中國醫療器材登記法規問題集
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HLF-TW-10
請問中國對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of medical devices in China? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
在中國，國務院食品藥品監督管理部門(NMPA)負責全國醫療器材監督管理工作，國務院有關部門在各自的職責範圍內負責與醫療器材有關的監督管理工作，縣級以上地方人民政府食品藥品監督管理部門負責行政區域的醫療器材監督管理工作，縣級以上地方人民政府有關部門在各自的職責範圍內負責與醫療器材有關的監督管理工作。
醫療器材是指直接或間接用於人體的儀器、設備、器具、體外診斷試劑及校準物、材料，以及其他類似或相關的物品，包括所需要的計算機軟體。
醫療器材的使用旨在達到下列預期目的：
1.對疾病的預防、診斷、治療、監護、緩解。
2.對損傷或者殘疾的診斷、治療、監護、緩解、補償。
3.對解剖或者生理過程的研究、替代、調節或者支持。
4.對生命的支持或者維持。
5.妊娠控制。
6.通過對來自人體的樣本進行檢查，為醫療或者診斷目的提供信息。
醫療器材按照風險程度實行分類管理：
1.第一類：險程度低，實行常規管理可以保證其安全、有效的醫療器材。
2.第二類：具有中度風險，需要嚴格控制管理以保證其安全、有效的醫療器材。
3.第三類：具有較高風險，需要採取特別措施嚴格控制管理以保證其安全、有效的醫療器材。
In China, the Food and Drug Administration of the State Council (NMPA) is responsible for the supervision and administration of medical devices nationwide, the relevant departments of the State Council are responsible for the supervision and administration of medical devices within their respective responsibilities, and the food and drug administrations of local people’s governments at or above the county level Responsible for the supervision and management of medical device in the administrative region, and the relevant departments of the local people’s government at or above the county level are responsible for the supervision and management of medical device within their respective scope of duties.
Medical devices refer to instruments, device, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including required computer software, that are directly or indirectly used in the human body.
The use of medical devices is intended to achieve the following intended purposes:
- Prevention, diagnosis, treatment, monitoring, and mitigation of diseases.
- Diagnosis, treatment, monitoring, mitigation, and compensation for damage or disability.
- The study, substitution, regulation or support of anatomical or physiological processes.
- Support or maintenance of life.
- Pregnancy control.
- To provide information for medical or diagnostic purposes through the examination of samples from the human body.
Medical device shall be managed according to the level of risk:
- Category I : low-risk medical device, which can be guaranteed safe and effective by routine management.
- Category II: medical devices with moderate risk and require strict control and management to ensure their safety and effectiveness.
- Category III: high-risk medical devices that require special measures to strictly control and manage to ensure their safety and effectiveness.
【參考連結】
https://www.nmpa.gov.cn/directory/web/nmpa/index.html
https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/kpzhsh/kpzhshylqx/20171025134201114.html
HLF-TW-20
外國公司要到中國銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell medical devices in China, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要，從事醫療器材經營活動需為當地企業向所在地設區的市級負責藥品監督管理的部門(市政府)取得經營許可/備案，其中第一類醫療器材不需要經營許可和備案、第二類需完成備案、第三類需獲得許可。
醫療器材經營許可證
從事醫療器材經營活動，應遵守法律和醫療器材經營質量管理規範等要求，保證醫療器材經營過程信息真實、準確、完整和可追溯，醫療器材註冊人、備案人可以自行銷售，也可以委託醫療器材經營企業銷售其註冊、備案的醫療器材。
1.醫療器材經營實施分類管理
．經營第一類醫療器材不需要許可和備案。
．經營第二類醫療器材實行備案管理。
．經營第三類醫療器材實行許可管理。
- 從事醫療器材經營，應具備條件
．與經營範圍和經營規模相適應的質量管理機構或者質量管理人員，質量管理人員應具有相關專業學歷或者職稱。
．與經營範圍和經營規模相適應的經營場所。
．與經營範圍和經營規模相適應的儲存條件。
．與經營的醫療器材相適應的質量管理制度。
．與經營的醫療器材相適應的專業指導、技術培訓和售後服務的質量管理機構或者人員。
．從事第三類醫療器材經營的企業還應具有符合醫療器材經營質量管理制度要求的電腦管理系統，保證經營的產品可追溯。
鼓勵從事第一類、第二類醫療器材經營的企業建立符合醫療器材經營質量管理制度要求的電腦信息管理系統。
3.申請機構：所在地設區的市級負責藥品監督管理的部門。
- 第二類醫療器材備案申請資料
．法定代表人（企業負責人）、質量負責人身份證明、學歷或者職稱相關材料複本。
．企業組織機構與部門設置。
．醫療器材經營範圍、經營方式。
．經營場所和庫房的地理位置圖、平面圖、房屋產權文件或者租賃協議複本。
．主要經營設施、設備目錄。
．經營質量管理制度、工作程序等文件目錄。
．經辦人授權文件。
5.第三類醫療器材許可申請資料
．法定代表人（企業負責人）、質量負責人身份證明、學歷或者職稱相關材料複本。
．企業組織機構與部門設置。
．醫療器材經營範圍、經營方式。
．經營場所和庫房的地理位置圖、平面圖、房屋產權文件或者租賃協議複本。
．主要經營設施、設備目錄。
．經營質量管理制度、工作程序等文件目錄。
．信息管理系統基本情況。
．經辦人授權文件。
6.備註
．醫療器材經營許可證由國家藥品監督管理局統一樣式，由市級負責藥品監督管理的部門印製，電子證書與紙質證書具有同等法律效力。
．醫療器材經營許可證有效期屆滿需要延續的，醫療器材經營企業應在有效期屆滿前90個工作日至30個工作日期間提出延續申請。
．經營企業跨設區的市設置庫房的，由醫療器材經營許可發證部門或者備案部門通報庫房所在地設區的市級負責藥品監督管理的部門。
．經營企業新設立獨立經營場所的，應依法單獨申請醫療器材經營許可或者進行備案。
．醫療器材經營許可證有效期為5年，載明許可證編號、企業名稱、統一社會信用代碼、法定代表人、企業負責人、住所、經營場所、經營方式、經營範圍、庫房地址、發證部門、發證日期和有效期限等事項。
．同時申請第三類醫療器材經營許可和進行第二類醫療器材經營備案的，或者已經取得第三類醫療器材經營許可進行第二類醫療器材備案的，可以免予提交相應資料。
Yes, to engage in medical device business activities, it is necessary for local enterprises to obtain a business license/filing from the department responsible for drug supervision and management at the municipal level (municipal government) with districts where they are located. The filing needs to be completed, and Category III needs to be licensed.
Medical Device Business License
To engage in medical device business activities, they should abide by the requirements of laws and medical device business quality management regulations, and ensure that the information in the medical device business process is true, accurate, complete and traceable. Operating enterprises sell their registered and filed medical device.
- Implement Categoryified management of medical device business
．No license and filing are required to operate Category I medical device.
．The management of Category II of medical device shall be subject to recordation management.
．The operation of the third-Category medical device shall be subject to licensing management.
- To engage in the business of medical device, conditions shall be met
．Quality management institutions or quality management personnel that are suitable for business scope and business scale, and quality management personnel shall have relevant professional education or professional titles.
．A business site that is compatible with the business scope and scale of business.
．Storage conditions appropriate to the business scope and scale of operation.
．A quality management system that is compatible with the medical device that is being operated.
．Quality management institutions or personnel for professional guidance, technical training and after-sales service that are compatible with the medical device in operation.
．Enterprises engaged in the operation of Category III medical device should also have a computer management system that meets the requirements of the quality management system for medical device operation, to ensure that the products they operate can be traced back. Enterprises engaged in the operation of the first and second categories of medical device are encouraged to establish a computer information management system that meets the requirements of the quality management system for medical device operation.
- The applicant agency: the department responsible for drug supervision and administration at the city level with districts where it is located.
- Application materials for filing of Category II medical devices
．The legal representative (the person in charge of the enterprise), the identity certificate of the person in charge of quality, and a copy of the relevant materials of the educational background or professional title.
．Enterprise organization and department settings.
．The scope and mode of operation of medical device.
．A copy of the location map, floor plan, property title document or lease agreement of the business premises and warehouse.
．Main operating facilities, device catalog.
．Catalogue of documents such as operating quality management system and work procedures.
．Authorization documents of the manager.
- Application materials for the license of Category III of medical device
．The legal representative (the person in charge of the enterprise), the identity certificate of the person in charge of quality, and a copy of the relevant materials of the educational background or professional title.
．Enterprise organization and department settings.
．The scope and mode of operation of medical device.
．A copy of the location map, floor plan, building title documents or lease agreement of the business premises and warehouse.
．Main business facilities, device catalog.
．Catalogue of documents such as operating quality management system and work procedures.
．Basic information of the information management system.
．Authorization documents of the manager.
- Note
．The medical device business license is unified by the State Drug Administration and printed by the municipal department in charge of drug supervision and administration. The electronic certificate has the same legal effect as the paper certificate.
．If the validity period of the medical device business license needs to be renewed, the medical device business enterprise should apply for a renewal within 90 working days to 30 working days before the validity period expires.
．If the operating enterprise sets up warehouses in a city divided into districts, the medical device business license issuing department or the filing department shall notify the department responsible for drug supervision and administration at the districted city level where the warehouse is located.
．If a business enterprise establishes a new independent business place, it shall separately apply for a medical device business license or record it according to law.
．The medical device business license is valid for 5 years, indicating the license number, enterprise name, unified social credit code, legal representative, person in charge of the enterprise, domicile, business location, business method, business scope, warehouse address, issuing department, Issue date and validity period, etc.
．Those who apply for a Category III medical device business license and conduct a Category II medical device business record at the same time, or who have obtained a Category III medical device business license for a Category II medical device record, may be exempted from submitting the corresponding materials.
【參考連結】
https://gkml.samr.gov.cn/nsjg/fgs/202203/t20220322_340682.html
HLF-TW-25
假如需要辦理，請問中國有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
杭州甘德企業管理諮詢有限公司
深圳市明邦財稅集團有限公司
HLF-TW-30
外國公司要到中國銷售醫療器材，可以指派中國公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell medical devices in China, can it assign an China company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
醫療器材註冊人、備案人可以自行銷售，也可以委託醫療器材經營企業銷售其註冊、備案的醫療器材，委託之醫療器材經營企業應符合條件並簽訂委託協議，明確雙方的權利和義務。
1.從事醫療器材經營，應具備條件
．與經營範圍和經營規模相適應的質量管理機構或者質量管理人員，質量管理人員應具有相關專業學歷或者職稱。
．與經營範圍和經營規模相適應的經營場所。
．與經營範圍和經營規模相適應的儲存條件。
．與經營的醫療器材相適應的質量管理制度。
．與經營的醫療器材相適應的專業指導、技術培訓和售後服務的質量管理機構或者人員。
．從事第三類醫療器材經營的企業還應具有符合醫療器材經營質量管理制度要求的電腦管理系統，保證經營的產品可追溯。鼓勵從事第一類、第二類醫療器材經營的企業建立符合醫療器材經營質量管理制度要求的電腦信息管理系統。
2.醫療器材經營企業應建立進貨查驗記錄製度，購進醫療器材時應查驗供貨企業的資質，以及醫療器材註冊證和備案信息、合格證明文件。進貨查驗記錄應真實、準確、完整和可追溯，包括：
．醫療器材的名稱、型號、規格、數量。
．醫療器材註冊證編號或者備案編號。
．醫療器材註冊人、備案人和受託生產企業名稱、生產許可證號或者備案編號。
．醫療器材的生產批號或者序列號、使用期限或者失效日期、購貨日期等。
．供貨者的名稱、地址以及聯繫方式。
．進貨查驗記錄應保存至醫療器材有效期滿後2年；沒有有效期的，不得少於5年。植入類醫療器材進貨查驗記錄應永久保存。
- 醫療器材註冊人、備案人和經營企業委託其他單位運輸、儲存醫療器材的，應對受託方運輸、儲存醫療器材的質量保障能力進行評估，並與其簽訂委託協議，明確運輸、儲存過程中的質量責任，確保運輸、儲存過程中的質量安全。
- 從事第二類、第三類醫療器材批發業務以及第三類醫療器材零售業務的經營企業應建立銷售記錄製度。
銷售記錄信息應真實、準確、完整和可追溯。銷售記錄包括：
．醫療器材的名稱、型號、規格、註冊證編號或者備案編號、數量、單價、金額。
．醫療器材的生產批號或者序列號、使用期限或者失效日期、銷售日期。
．醫療器材註冊人、備案人和受託生產企業名稱、生產許可證編號或者備案編號。
．從事第二類、第三類醫療器材批發業務的企業，銷售記錄還應包括購貨者的名稱、地址、聯繫方式、相關許可證明文件編號或者備案編號等。
．銷售記錄應保存至醫療器材有效期滿後2年；沒有有效期的，不得少於5年。植入類醫療器材銷售記錄應永久保存。
- 醫療器材經營企業應提供售後服務。約定由供貨者或者其他機構提供售後服務的，經營企業應加強管理，保證醫療器材售後的安全使用。
- 醫療器材經營企業應配備專職或者兼職人員負責售後管理，對客戶投訴的質量問題應查明原因，採取有效措施及時處理和反饋，並做好記錄，必要時及時通知醫療器材註冊人、備案人、生產經營企業。
- 醫療器材經營企業應協助醫療器材註冊人、備案人，對所經營的醫療器材開展不良事件監測，按照國家藥品監督管理局的規定，向醫療器材不良事件監測技術機構報告。
產品責任
1.醫療器材生產企業應建立健全醫療器材召回管理制度，收集醫療器材安全相關信息，對可能的缺陷產品進行調查、評估，及時召回缺陷產品。
2.進口醫療器材的境外製造廠商在中國境內指定的代理人應將僅在境外實施醫療器材召回的有關信息及時報告國家食品藥品監督管理總局；凡涉及在境內實施召回的，中國境內指定的代理人應實施。
3.醫療器材經營企業、使用單位應積極協助醫療器材生產企業對缺陷產品進行調查、評估，主動配合生產企業履行召回義務，按照召回計劃及時傳達、反饋醫療器材召回信息，控制和收回缺陷產品。
4.醫療器材經營企業、使用單位發現其經營、使用的醫療器材可能為缺陷產品的，應立即暫停銷售或者使用該醫療器材，及時通知醫療器材生產企業或者供貨商，並向所在地省、自治區、直轄市食品藥品監督管理部門報告；使用單位為醫療機構的，還應同時向所在地省、自治區、直轄市衛生行政部門報告。
5.醫療器材經營企業、使用單位所在地省、自治區、直轄市食品藥品監督管理部門收到報告後，應及時通報醫療器材生產企業所在地省、自治區、直轄市食品藥品監督管理部門。
- 對存在缺陷的醫療器材產品進行評估的主要內容包括：
．產品是否符合強制性標準、經註冊或者備案的產品技術要求。
．在使用醫療器材過程中是否發生過故障或者傷害。
．在現有使用環境下是否會造成傷害，是否有科學文獻、研究、相關試驗或者驗證能夠解釋傷害發生的原因。
．傷害所涉及的地區範圍和人群特點。
．對人體健康造成的傷害程度。
．傷害發生的概率。
．發生傷害的短期和長期後果。
．其他可能對人體造成傷害的因素。
7.根據醫療器材缺陷的嚴重程度，醫療器材召回分為：
．一級召回：使用該醫療器材可能或者已經引起嚴重健康危害的。
．二級召回：使用該醫療器材可能或者已經引起暫時的或者可逆的健康危害的。
．三級召回：使用該醫療器材引起危害的可能性較小但仍需要召回的。
．醫療器材生產企業應根據具體情況確定召回級別並根據召回級別與醫療器材的銷售和使用情況，科學設計召回計劃並組織實施。
8.生產企業作出醫療器材召回決定的，一級召回應在1日內，二級召回應在3日內，三級召回應在7日內，通知到有關醫療器材經營企業、使用單位或者告知使用者。召回通知應包括以下內容：
．召回醫療器材名稱、型號規格、批次等基本信息。
．召回的原因。
．召回的要求，如立即暫停銷售和使用該產品、將召回通知轉發到相關經營企業或者使用單位等。
．召回醫療器材的處理方式。
- 醫療器材生產企業對召回醫療器材的處理應有詳細的記錄，並向醫療器材生產企業所在地省、自治區、直轄市食品藥品監督管理部門報告，記錄應保存至醫療器材註冊證失效後5年，第一類醫療器材召回的處理記錄應保存5年。
對通過警示、檢查、修理、重新標籤、修改並完善說明書、軟件更新、替換、銷毀等方式能夠消除產品缺陷的，可以在產品所在地完成上述行為。需要銷毀的，應在食品藥品監督管理部門監督下銷毀。
10.醫療器材生產企業應在召回完成後10個工作日內對召回效果進行評估，並向所在地省、自治區、直轄市食品藥品監督管理部門提交醫療器材召回總結評估報告。
Medical device registrants and filers can sell on their own, or they can entrust medical device operators to sell their registered and filed medical devices. The entrusted medical device operators should meet the conditions and sign an entrustment agreement, clarifying the rights and obligations of both parties.
- To engage in the operation of medical device, conditions shall be met
．Quality management institutions or quality management personnel that are suitable for business scope and business scale, and quality management personnel shall have relevant professional education or professional titles.
．A business site that is compatible with the business scope and scale of business.
．Storage conditions suitable for business scope and business scale.
．A quality management system that is compatible with the medical device that is being operated.
．Quality management institutions or personnel for professional guidance, technical training and after-sales service that are compatible with the operating medical device.
．Enterprises engaged in the operation of Category III medical device should also have a computer management system that meets the requirements of the quality management system for medical device operation, to ensure that the products they operate can be traced back. Enterprises engaged in the operation of the first and second categories of medical device are encouraged to establish a computer information management system that meets the requirements of the quality management system for medical device operation.
- Medical device operating enterprises should establish a purchase inspection record system, and when purchasing medical device, they should check the qualifications of the supplier, as well as the medical device registration certificate and record information, and qualification certificates. Incoming inspection records should be true, accurate, complete and traceable, including:
．Name, model, specification and quantity of medical device.
．Medical device registration certificate number or record number.
．Names, production license numbers or filing numbers of medical device registrants, filing and entrusted manufacturers.
．The production batch number or serial number, expiration date or expiration date, purchase date, etc. of the medical device.
．Supplier’s name, address and contact information.
．Purchase inspection records shall be kept for 2 years after the expiration date of the medical device; if there is no valid period, it shall not be less than 5 years. Implantable medical device purchase inspection records shall be kept permanently.
- If the medical device registrant, filer and operating enterprise entrust other units to transport and store medical devices, they should evaluate the quality assurance ability of the entrusted party to transport and store medical devices, and sign an entrustment agreement with them to clarify the transportation and storage process. Quality responsibility to ensure quality safety during transportation and storage.
- Enterprises engaged in the wholesale business of Category II and Category III medical device and the retail business of Category III medical device shall establish a sales record system. Sales record information should be true, accurate, complete and traceable. Sales records include:
．The name, model, specification, registration certificate number or filing number, quantity, unit price, and amount of the medical device.
．The production batch number or serial number, use period or expiration date, and sale date of the medical device.
．Medical device registrant, filing and entrusted production enterprise name, production license number or filing number.
．For enterprises engaged in the wholesale business of Category II and Category III medical device, the sales records shall also include the purchaser’s name, address, contact information, relevant license document number or filing number, etc.
．Sales records shall be kept for 2 years after the expiration of the medical device’s validity period; if there is no validity period, it shall not be less than 5 years. Implantable medical device sales records shall be kept permanently.
- Medical device operating enterprises should provide after-sales service. If it is agreed that the supplier or other organization will provide after-sales service, the operating enterprise shall strengthen management to ensure the safe use of medical device after sales.
- Medical device operating enterprises should be equipped with full-time or part-time personnel to be responsible for after-sales management, and should find out the reasons for customer complaints about quality problems, take effective measures to deal with and give feedback in a timely manner, and keep records. Filers, production and operation enterprises.
- Medical device operating companies should assist medical device registrants and filers to monitor adverse events of the medical devices they operate, and report to the technical institutions for monitoring adverse events of medical devices in accordance with the regulations of the State Drug Administration.
Product Liability
- Medical device manufacturers should establish and improve the medical device recall management system, collect information on medical device safety, investigate and evaluate possible defective products, and recall defective products in a timely manner.
- The agent designated by the overseas manufacturer of imported medical device in China shall promptly report the relevant information of the recall of medical device only overseas to the State Food and Drug Administration; if the recall in China is involved, the agent designated in China shall people should implement.
- Medical device operating enterprises and users should actively assist medical device manufacturers to investigate and evaluate defective products, actively cooperate with manufacturers to fulfill recall obligations, timely communicate and feedback medical device recall information in accordance with the recall plan, and control and recover defective products.
- If a medical device operating enterprise or user unit finds that the medical device it operates or uses may be a defective product, it should immediately suspend the sale or use of the medical device, promptly notify the medical device manufacturer or supplier, and report to the province or autonomous region where it is located. , the municipal food and drug supervision and administration department; if the user is a medical institution, it should also report to the health administrative department of the province, autonomous region, or municipality directly under the Central Government at the same time.
- After receiving the report, the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device operating enterprise or user unit is located shall promptly notify the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located.
- The main contents of the evaluation of defective medical device products include:
．Whether the product complies with mandatory standards, registered or filed product technical requirements.
．Whether there has been any malfunction or injury during the use of medical device.
．Whether it will cause harm in the current use environment, and whether there is scientific literature, research, relevant experiments or verification that can explain the reasons for the harm.
．The scope of the area and the characteristics of the population involved in the injury.
．The degree of harm to human health.
．The probability of injury occurring.
．Short-term and long-term consequences of injury.
．Other factors that may cause harm to the human body.
- According to the severity of medical device defects, medical device recalls are divided into:
．Category I recall: The use of the medical device may or has caused serious health hazards.
．Category II recall: The use of the medical device may or has caused temporary or reversible health hazards.
．Category III recall: The use of the medical device is less likely to cause harm but still needs to be recalled.
．Medical device manufacturers should determine the recall level according to the specific situation and scientifically design recall plans and organize their implementation according to the recall level and the sales and use of medical device.
- If a manufacturer makes a decision to recall medical device, the first-level recall should be within 1 day, the second-level recall should be within 3 days, and the third-level recall should be within 7 days, and the relevant medical device operators, user units or users should be notified. The recall notice should include the following:
．Basic information such as the name, model specification, batch, etc. of the recalled medical device.
．Reason for recall.
．Recall requirements, such as immediately suspending the sale and use of the product, forwarding the recall notice to the relevant operating enterprise or user unit, etc.
．How to dispose of recalled medical devices.
- The medical device manufacturer should keep detailed records on the handling of recalled medical devices, and report to the food and drug supervision and administration department of the province, autonomous region, or municipality where the medical device manufacturer is located. The records should be kept for 5 years after the medical device registration certificate expires. The handling records for the recall of Category I medical devices shall be kept for 5 years. Where product defects can be eliminated by means of warning, inspection, repair, relabeling, modification and improvement of manuals, software update, replacement, destruction, etc., the above actions may be completed at the location of the product. Those that need to be destroyed shall be destroyed under the supervision of the food and drug administration.
- The medical device manufacturer shall evaluate the recall effect within 10 working days after the recall is completed, and submit the medical device recall summary evaluation report to the food and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located.
【參考連結】
https://gkml.samr.gov.cn/nsjg/fgs/202203/t20220322_340682.html
https://gkml.samr.gov.cn/nsjg/bgt/202106/t20210629_331728.html
HLF-TW-35
假如需要辦理指派中國公司擔任營業代理人，請問中國有專業服務公司可以協助？
Evershine RD：
浙江天松醫療器材股份有限公司
北京盈欣科儀醫療器材有限公司
HLF-TW-40
外國公司銷售到中國醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing medical devices sold to China? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
進口醫療器材需以中國境內設立的代表機構名義或指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門(NMPA)申請醫療器材產品備案/註冊。
醫療器材產品註冊與備案
1.註冊與備案
．第一類：醫療器材產品備案管理
．第二類、第三類：醫療器材實行產品註冊管理。
2.申請人
．第一類醫療器材的境外生產企業，由其在中國境內設立的代表機構或者指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門提交備案資料和備案人所在國（地區）主管部門准許該醫療器材上市銷售的證明文件。
．第二類、第三類醫療器材的境外生產企業，應由其在中國境內設立的代表機構或者指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門提交註冊申請資料和註冊申請人所在國（地區）主管部門准許該醫療器材上市銷售的證明文件。
3.申請網頁：
第一類https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
第二、第三類
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204400101
4.有效期：醫療器材註冊證有效期為5年。有效期屆滿需要延續註冊的，應在有效期屆滿6個月前向原註冊部門提出延續註冊的申請。
5.第一類醫療器材產品備案和申請第二類、第三類醫療器材產品註冊，應提交下列資料：
．產品風險分析資料；
．產品技術要求；
．產品檢驗報告；
．臨床評價資料；
．產品說明書及標籤樣稿；
．與產品研製、生產有關的質量管理體系文件；
．證明產品安全、有效所需的其他資料。
6.備註
．醫療器材註冊申請人、備案人應對所提交資料的真實性負責。
．第一類醫療器材產品備案，由備案人向所在地設區的市級人民政府食品藥品監督管理部門提交備案資料。
其中，產品檢驗報告可以是備案人的自檢報告；臨床評價資料不包括臨床試驗報告，可以是通過文獻、同類產品臨床使用獲得的數據證明該醫療器材安全、有效的資料。
．申請第二類醫療器材產品註冊，註冊申請人應向所在地省、自治區、直轄市人民政府食品藥品監督管理部門提交註冊申請資料。
申請第三類醫療器材產品註冊，註冊申請人應向國務院食品藥品監督管理部門提交註冊申請資料。
．第二類、第三類醫療器材產品註冊申請資料中的產品檢驗報告應是醫療器材檢驗機構出具的檢驗報告；臨床評價資料應包括臨床試驗報告，
．註冊申請自受理之日起3個工作日內將註冊申請資料轉交技術審評機構，技術審評機構在完成技術審評後向食品藥品監督管理部門提交審評意見，於20個工作日內作出決定。
對符合安全、有效要求的，准予註冊並發給醫療器材註冊證；對不符合要求的，不予註冊並書面說明理由。
．第一類醫療器材產品備案，不需要進行臨床試驗。第二類、第三類醫療器材產品註冊，應進行臨床試驗；但是，有下列情形之一的，可以免於進行臨床試驗：工作機理明確、設計定型，生產工藝成熟，已上市的同品種醫療器材臨床應用多年且無嚴重不良事件記錄，不改變常規用途的；通過非臨床評價能夠證明該醫療器材安全、有效的；通過對同品種醫療器材臨床試驗或者臨床使用獲得的數據進行分析評價，能夠證明該醫療器材安全、有效的。
．第三類醫療器材進行臨床試驗對人體具有較高風險的，應經國務院食品藥品監督管理部門批准。臨床試驗對人體具有較高風險的第三類醫療器材目錄由國務院食品藥品監督管理部門製定、調整併公佈。
標籤、說明書
1.說明書應包括以下內容：
．產品名稱、型號、規格。
．註冊人或者備案人的名稱、住所、聯繫方式及售後服務單位，進口醫療器材還應載明代理人的名稱、住所及聯繫方式。
．生產企業的名稱、住所、生產地址、聯繫方式及生產許可證編號或者生產備案憑證編號，委託生產的還應標註受託企業的名稱、住所、生產地址、生產許可證編號或者生產備案憑證編號。
．醫療器材註冊證編號或者備案憑證編號。
．產品技術要求的編號。
．產品性能、主要結構組成或者成分、適用範圍。
．禁忌症、注意事項、警示以及提示的內容。
．安裝和使用說明或者圖示，由消費者個人自行使用的醫療器材還應具有安全使用的特別說明
．產品維護和保養方法，特殊儲存、運輸條件、方法。
．生產日期，使用期限或者失效日期。
．配件清單，包括配件、附屬品、損耗品更換週期以及更換方法的說明等。
．醫療器材標籤所用的圖形、符號、縮寫等內容的解釋。
．說明書的編制或者修訂日期。
．其他應標註的內容。
．重複使用的醫療器材應在說明書中明確重複使用的處理過程，包括清潔、消毒、包裝及滅菌的方法和重複使用的次數或者其他限制。
2.說明書中有關注意事項、警示以及提示性內容主要包括：
．產品使用的對象。
．潛在的安全危害及使用限制。
．產品在正確使用過程中出現意外時，對操作者、使用者的保護措施以及應採取的應急和糾正措施。
．必要的監測、評估、控制手段。
．一次性使用產品應註明一次性使用字樣或者符號，已滅菌產品應註明滅菌方式以及滅菌包裝損壞後的處理方法，使用前需要消毒或者滅菌的應說明消毒或者滅菌的方法。
．產品需要同其他醫療器材一起安裝或者聯合使用時，應註明聯合使用器材的要求、使用方法、注意事項。
．在使用過程中，與其他產品可能產生的相互干擾及其可能出現的危害。
．產品使用中可能帶來的不良事件或者產品成分中含有的可能引起副作用的成分或者輔料。
．醫療器材廢棄處理時應注意的事項，產品使用後需要處理的，應註明相應的處理方法。
．根據產品特性，應提示操作者、使用者註意的其他事項。
- 標籤應包括以下內容：
．產品名稱、型號、規格
．註冊人或者備案人的名稱、住所、聯繫方式，進口醫療器材還應載明代理人的名稱、住所及聯繫方式
．醫療器材註冊證編號或者備案憑證編號
．生產企業的名稱、住所、生產地址、聯繫方式及生產許可證編號或者生產備案憑證編號，委託生產的還應標註受託企業的名稱、住所、生產地址、生產許可證編號或者生產備案憑證編號
．生產日期，使用期限或者失效日期
．電源連接條件、輸入功率
．根據產品特性應標註的圖形、符號以及其他相關內容
．必要的警示、注意事項
．特殊儲存、操作條件或者說明
．使用中對環境有破壞或者負面影響的醫療器材，其標籤應包含警示標誌或者中文警示說明
．帶放射或者輻射的醫療器材，其標籤應包含警示標誌或者中文警示說明
．醫療器材標籤因位置或者大小受限而無法全部標明上述內容的，至少應標註產品名稱、型號、規格、生產日期和使用期限或者失效日期，並在標籤中明確標示：其他內容詳見說明書。
- 醫療器材說明書和標籤不得有下列內容：
．含有：療效最佳、保證治愈、包治、根治、即刻見效、完全無毒副作用等表示功效的斷言或者保證的。
．含有：最高技術、最科學、最先進、最佳等絕對化語言和表示的。
．說明治愈率或者有效率的。
．與其他企業產品的功效和安全性相比較的。
．含有：保險公司保險、無效退款等承諾性語言的。
．利用任何單位或者個人的名義、形像作證明或者推薦的
．含有誤導性說明，使人感到已經患某種疾病，或者使人誤解不使用該醫療器材會患某種疾病或者加重病情的表述，以及其他虛假、誇大、誤導性的內容。
．法律、法規規定禁止的其他內容。
5.其他
．醫療器材說明書應由註冊申請人或者備案人在醫療器材註冊或者備案時，提交食品藥品監督管理部門審查或者備案，提交的說明書內容應與其他註冊或者備案資料相符合。
．醫療器材說明書和標籤對疾病名稱、專業名詞、診斷治療過程和結果的表述，應採用國家統一發布或者規範的專用詞彙，度量衡單位應符合國家相關標準的規定。
．醫療器材最小銷售單元應附有說明書，醫療器材的使用者應按照說明書使用醫療器材。
．產品名稱應使用通用名稱，通用名稱應符合國家食品藥品監督管理總局製定的醫療器材命名規則。第二類、第三類醫療器材的產品名稱應與醫療器材註冊證中的產品名稱一致，產品名稱應清晰地標明在說明書和標籤的顯著位置。
．醫療器材說明書和標籤文字內容應使用中文，中文的使用應符合國家通用的語言文字規範。醫療器材說明書和標籤可以附加其他文種，但應以中文表述為準。醫療器材說明書和標籤中的文字、符號、表格、數字、圖形等應準確、清晰、規範。
To import medical device, it is necessary to apply to the Food and Drug Administration (NMPA) of the State Council for filing/registration of medical device in the name of a representative office established in China or a designated enterprise legal person within China as an agent.
Registration and filing of medical device products
- Registration and filing
．Category I: Filing management of medical device products
．Category II and Category III: Medical device is subject to product registration management.
- The applicant
．For overseas manufacturers of Category I medical devices, their representative offices in China or designated corporate legal persons in China shall be their agents to submit filing materials and the competent authorities of the country (region) where the filing person is located to the Food and Drug Administration of the State Council. Evidence that the medical device is approved for sale on the market.
．Overseas manufacturers of Category II and Category III medical devices shall submit registration application materials and registration applicants to the Food and Drug Administration of the State Council through their representative offices established in China or designated corporate legal persons in China as agents. Documents proving that the competent authority of the country (region) where the medical device is approved for sale on the market.
- Application webpage:
Category I https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
Category II &and Category III
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204400101
- Validity period: The medical device registration certificate is valid for 5 years. If it is necessary to renew the registration after the expiry of the validity period, an application for renewal of the registration shall be submitted to the original registration department 6 months before the expiry of the validity period.
- The following materials should be submitted for filing of Category I medical device products and applying for the registration of Category II and Category III medical device products:
．Product risk analysis information;
．Product technical requirements;
．Product inspection report;
．Clinical evaluation information;
．Product brochures and label samples;
．Quality management system documents related to product development and production;
．Other information required to prove the safety and efficacy of the product.
- Note
．The medical device registration applicant and filing person shall be responsible for the authenticity of the submitted materials.
．For the filing of Category I medical device products, the filing person shall submit the filing materials to the food and drug supervision and administration department of the people’s government at the municipal level where the district is located. Among them, the product inspection report can be the self-inspection report of the filer; the clinical evaluation data does not include the clinical trial report, and can be the data obtained through literature and the clinical use of similar products to prove that the medical device is safe and effective.
．To apply for the registration of Category II medical device products, the registration applicant should submit the registration application materials to the food and drug administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where it is located. To apply for the registration of a Category III medical device product, the registration applicant shall submit the registration application materials to the food and drug administration under the State Council.
．The product inspection report in the application materials for the registration of Category II and Category III medical device products shall be the inspection report issued by the medical device inspection institution; the clinical evaluation data shall include the clinical trial report,
．The registration application shall transfer the registration application materials to the technical review agency within 3 working days from the date of acceptance. Decide. For those that meet the safety and effectiveness requirements, the registration shall be granted and a medical device registration certificate shall be issued; for those that do not meet the requirements, the registration shall not be granted and the reasons shall be explained in writing.
．For the filing of Category I of medical device products, clinical trials are not required. For the registration of Category II and Category III medical device products, clinical trials shall be conducted; however, clinical trials may be exempted under any of the following circumstances: the working mechanism is clear, the design is finalized, the production process is mature, and the same variety of medical devices that have been marketed The medical device has been used clinically for many years and has no serious adverse event records, and does not change its routine use; it can be proved that the medical device is safe and effective through non-clinical evaluation; through the analysis and evaluation of the data obtained from clinical trials or clinical use of the same variety of medical devices, it can be proved that the medical device is safe and effective. Prove that the medical device is safe and effective.
．If the clinical trials of Category III medical devices have relatively high risks to the human body, they shall be approved by the food and drug supervision and administration department of the State Council. The catalogue of Category III medical devices with relatively high risks to humans in clinical trials shall be formulated, adjusted and published by the food and drug administration under the State Council.
Labels, Instructions
- Instructions should include the following:
．Product name, model, specification.
．The name, address, contact information and after-sales service unit of the registrant or filing person, and the name, address and contact information of the agent for imported medical device should also be indicated.
．The name, domicile, production address, contact information and production license number or production record certificate number of the production enterprise, and the entrusted production shall also be marked with the name, domicile, production address, production license number or production record certificate number of the entrusted enterprise.
．Medical device registration certificate number or filing certificate number.
．Number of product technical requirements.
．Product performance, main structural composition or ingredients, and scope of application.
．Contents of contraindications, precautions, warnings and prompts.
．Installation and use instructions or illustrations, medical device used by consumers themselves should also have special instructions for safe use
．Product care and maintenance methods, special storage and transportation conditions, methods.
．Date of manufacture, expiration date or expiration date.
．List of accessories, including accessories, accessories, replacement cycle of consumables and description of replacement methods.
．Explanation of graphics, symbols, abbreviations, etc. used on medical device labels.
．Date of preparation or revision of the manual.
．Other content that should be marked.
．For reusable medical devices, the handling procedures for reuse, including cleaning, disinfection, packaging, and sterilization methods, and the number of reuses or other limitations should be specified in the instructions.
- The relevant precautions, warnings and hints in the manual mainly include:
．The object used by the product.
．Potential Safety Hazards and Use Restrictions.
．The protective measures for operators and users, as well as emergency and corrective measures to be taken when an accident occurs during the correct use of the product.
．Necessary monitoring, evaluation and control means.
．Disposable products should be marked with single-use words or symbols, sterilized products should be marked with the sterilization method and the treatment method after the sterilization package is damaged, and the disinfection or sterilization method should be indicated if disinfection or sterilization is required before use.
．When the product needs to be installed or used in combination with other medical device, the requirements, usage methods and precautions for the combined use of the device should be indicated.
．In the process of use, the possible mutual interference with other products and the possible hazards.
．Adverse events that may occur during product use or ingredients or excipients contained in product ingredients that may cause side effects.
．Matters needing attention when disposing of medical device, if the product needs to be disposed of after use, the corresponding disposal method should be indicated.
．According to the characteristics of the product, the operator and user should be prompted to pay attention to other matters.
- The label shall include the following:
．Product name, model, specification
．The name, domicile and contact information of the registrant or filing person, and the name, domicile and contact information of the agent for imported medical device shall also be indicated
．Medical device registration certificate number or filing certificate number
．The name, domicile, production address, contact information and production license number or production record certificate number of the production enterprise. If the production is entrusted, the name, domicile, production address, production license number or production record certificate number of the entrusted enterprise shall also be marked
．Date of manufacture, expiry date or expiration date
．Power connection conditions, input power
．Graphics, symbols and other related content that should be marked according to product characteristics
．Necessary warnings and precautions
．Special storage, handling conditions or instructions
．For medical device that has damage or negative impact on the environment during use, the label should contain warning signs or Chinese warning instructions
．For medical device with radiation or radiation, the label should contain warning signs or Chinese warning instructions
．If the medical device label cannot fully indicate the above content due to the limited location or size, at least the product name, model, specification, production date and use period or expiration date should be marked, and clearly marked in the label: For other details, please refer to the instruction manual.
- Instructions and labels of medical devices shall not contain the following contents:
．Contains: the best curative effect, guaranteed cure, inclusive cure, radical cure, immediate effect, completely free of toxic and side effects, etc.
．Contains: the highest technology, the most scientific, the most advanced, the best and other absolute language and representation.
．Explain the cure rate or efficiency.
．Compared with the efficacy and safety of other enterprise products.
．Contains: insurance company insurance, invalid refund and other promise language.
．Using the name or image of any unit or individual as proof or recommendation
．Contains misleading statements that make people feel that they have suffered from a certain disease, or misunderstand the statement that a certain disease will be developed or aggravated by not using the medical device, and other false, exaggerated, and misleading content.
．Other content prohibited by laws and regulations.
- Others
．The medical device instructions shall be submitted by the registration applicant or filing person to the food and drug supervision and administration department for review or filing when the medical device is registered or filed, and the contents of the submitted instructions shall be consistent with other registration or filing materials.
．The description of disease names, professional terms, diagnosis and treatment process and results in medical device manuals and labels shall use special vocabulary uniformly issued or standardized by the state, and the units of measurement shall comply with the relevant national standards.
．The minimum sales unit of medical device should be accompanied by instructions, and users of medical device should use the medical device in accordance with the instructions.
．The product name should use the generic name, and the generic name should comply with the naming rules for medical devices formulated by the State Food and Drug Administration. The product names of Category II and Category III medical devices should be consistent with the product names in the medical device registration certificate, and the product names should be clearly marked in a prominent position on the instructions and labels.
．The instructions and labels of medical device should be written in Chinese, and the use of Chinese should comply with the national language standards. Instructions and labels of medical device may be attached in other languages, but the Chinese language shall prevail. The words, symbols, tables, figures, graphics, etc. in the instructions and labels of medical device shall be accurate, clear and standardized.
【參考連結】
https://gkml.samr.gov.cn/nsjg/bgt/202106/t20210629_331738.html
HLF-TW-45
請問在中國有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
瑞旭集團
https://www.cirs-group.com/foodcn
天健華成
HLF-TW-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
進口醫療器材需以中國境內設立的代表機構名義或指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門(NMPA)申請醫療器材產品備案/註冊。
醫療器材產品註冊與備案
1.註冊與備案
．第一類：醫療器材產品備案管理
．第二類、第三類：醫療器材實行產品註冊管理。
2.申請人
．第一類醫療器材的境外生產企業，由其在中國境內設立的代表機構或者指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門提交備案資料和備案人所在國（地區）主管部門准許該醫療器材上市銷售的證明文件。
．第二類、第三類醫療器材的境外生產企業，應由其在中國境內設立的代表機構或者指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門提交註冊申請資料和註冊申請人所在國（地區）主管部門准許該醫療器材上市銷售的證明文件。
3.申請網頁：
第一類https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
第二、第三類
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204400101
4.有效期：醫療器材註冊證有效期為5年。有效期屆滿需要延續註冊的，應在有效期屆滿6個月前向原註冊部門提出延續註冊的申請。
5.第一類醫療器材產品備案和申請第二類、第三類醫療器材產品註冊，應提交下列資料：
．產品風險分析資料；
．產品技術要求；
．產品檢驗報告；
．臨床評價資料；
．產品說明書及標籤樣稿；
．與產品研製、生產有關的質量管理體系文件；
．證明產品安全、有效所需的其他資料。
6.備註
．醫療器材註冊申請人、備案人應對所提交資料的真實性負責。
．第一類醫療器材產品備案，由備案人向所在地設區的市級人民政府食品藥品監督管理部門提交備案資料。
其中，產品檢驗報告可以是備案人的自檢報告；臨床評價資料不包括臨床試驗報告，可以是通過文獻、同類產品臨床使用獲得的數據證明該醫療器材安全、有效的資料。
．申請第二類醫療器材產品註冊，註冊申請人應向所在地省、自治區、直轄市人民政府食品藥品監督管理部門提交註冊申請資料。
申請第三類醫療器材產品註冊，註冊申請人應向國務院食品藥品監督管理部門提交註冊申請資料。
．第二類、第三類醫療器材產品註冊申請資料中的產品檢驗報告應是醫療器材檢驗機構出具的檢驗報告；臨床評價資料應包括臨床試驗報告，
．註冊申請自受理之日起3個工作日內將註冊申請資料轉交技術審評機構，技術審評機構在完成技術審評後向食品藥品監督管理部門提交審評意見，於20個工作日內作出決定。對符合安全、有效要求的，准予註冊並發給醫療器材註冊證；對不符合要求的，不予註冊並書面說明理由。
．第一類醫療器材產品備案，不需要進行臨床試驗。第二類、第三類醫療器材產品註冊，應進行臨床試驗；但是，有下列情形之一的，可以免於進行臨床試驗：工作機理明確、設計定型，生產工藝成熟，已上市的同品種醫療器材臨床應用多年且無嚴重不良事件記錄，不改變常規用途的；通過非臨床評價能夠證明該醫療器材安全、有效的；通過對同品種醫療器材臨床試驗或者臨床使用獲得的數據進行分析評價，能夠證明該醫療器材安全、有效的。
．第三類醫療器材進行臨床試驗對人體具有較高風險的，應經國務院食品藥品監督管理部門批准。臨床試驗對人體具有較高風險的第三類醫療器材目錄由國務院食品藥品監督管理部門製定、調整併公佈。
標籤、說明書
1.說明書應包括以下內容：
．產品名稱、型號、規格。
．註冊人或者備案人的名稱、住所、聯繫方式及售後服務單位，進口醫療器材還應載明代理人的名稱、住所及聯繫方式。
．生產企業的名稱、住所、生產地址、聯繫方式及生產許可證編號或者生產備案憑證編號，委託生產的還應標註受託企業的名稱、住所、生產地址、生產許可證編號或者生產備案憑證編號。
．醫療器材註冊證編號或者備案憑證編號。
．產品技術要求的編號。
．產品性能、主要結構組成或者成分、適用範圍。
．禁忌症、注意事項、警示以及提示的內容。
．安裝和使用說明或者圖示，由消費者個人自行使用的醫療器材還應具有安全使用的特別說明
．產品維護和保養方法，特殊儲存、運輸條件、方法。
．生產日期，使用期限或者失效日期。
．配件清單，包括配件、附屬品、損耗品更換週期以及更換方法的說明等。
．醫療器材標籤所用的圖形、符號、縮寫等內容的解釋。
．說明書的編制或者修訂日期。
．其他應標註的內容。
．重複使用的醫療器材應在說明書中明確重複使用的處理過程，包括清潔、消毒、包裝及滅菌的方法和重複使用的次數或者其他限制。
2.說明書中有關注意事項、警示以及提示性內容主要包括：
．產品使用的對象。
．潛在的安全危害及使用限制。
．產品在正確使用過程中出現意外時，對操作者、使用者的保護措施以及應採取的應急和糾正措施。
．必要的監測、評估、控制手段。
．一次性使用產品應註明一次性使用字樣或者符號，已滅菌產品應註明滅菌方式以及滅菌包裝損壞後的處理方法，使用前需要消毒或者滅菌的應說明消毒或者滅菌的方法。
．產品需要同其他醫療器材一起安裝或者聯合使用時，應註明聯合使用器材的要求、使用方法、注意事項。
．在使用過程中，與其他產品可能產生的相互干擾及其可能出現的危害。
．產品使用中可能帶來的不良事件或者產品成分中含有的可能引起副作用的成分或者輔料。
．醫療器材廢棄處理時應注意的事項，產品使用後需要處理的，應註明相應的處理方法。
．根據產品特性，應提示操作者、使用者註意的其他事項。
- 標籤應包括以下內容：
．產品名稱、型號、規格
．註冊人或者備案人的名稱、住所、聯繫方式，進口醫療器材還應載明代理人的名稱、住所及聯繫方式
．醫療器材註冊證編號或者備案憑證編號
．生產企業的名稱、住所、生產地址、聯繫方式及生產許可證編號或者生產備案憑證編號，委託生產的還應標註受託企業的名稱、住所、生產地址、生產許可證編號或者生產備案憑證編號
．生產日期，使用期限或者失效日期
．電源連接條件、輸入功率
．根據產品特性應標註的圖形、符號以及其他相關內容
．必要的警示、注意事項
．特殊儲存、操作條件或者說明
．使用中對環境有破壞或者負面影響的醫療器材，其標籤應包含警示標誌或者中文警示說明
．帶放射或者輻射的醫療器材，其標籤應包含警示標誌或者中文警示說明
．醫療器材標籤因位置或者大小受限而無法全部標明上述內容的，至少應標註產品名稱、型號、規格、生產日期和使用期限或者失效日期，並在標籤中明確標示：其他內容詳見說明書。
- 醫療器材說明書和標籤不得有下列內容：
．含有：療效最佳、保證治愈、包治、根治、即刻見效、完全無毒副作用等表示功效的斷言或者保證的。
．含有：最高技術、最科學、最先進、最佳等絕對化語言和表示的。
．說明治愈率或者有效率的。
．與其他企業產品的功效和安全性相比較的。
．含有：保險公司保險、無效退款等承諾性語言的。
．利用任何單位或者個人的名義、形像作證明或者推薦的
．含有誤導性說明，使人感到已經患某種疾病，或者使人誤解不使用該醫療器材會患某種疾病或者加重病情的表述，以及其他虛假、誇大、誤導性的內容。
．法律、法規規定禁止的其他內容。
5.其他
．醫療器材說明書應由註冊申請人或者備案人在醫療器材註冊或者備案時，提交食品藥品監督管理部門審查或者備案，提交的說明書內容應與其他註冊或者備案資料相符合。
．醫療器材說明書和標籤對疾病名稱、專業名詞、診斷治療過程和結果的表述，應採用國家統一發布或者規範的專用詞彙，度量衡單位應符合國家相關標準的規定。
．醫療器材最小銷售單元應附有說明書，醫療器材的使用者應按照說明書使用醫療器材。
．產品名稱應使用通用名稱，通用名稱應符合國家食品藥品監督管理總局製定的醫療器材命名規則。第二類、第三類醫療器材的產品名稱應與醫療器材註冊證中的產品名稱一致，產品名稱應清晰地標明在說明書和標籤的顯著位置。
．醫療器材說明書和標籤文字內容應使用中文，中文的使用應符合國家通用的語言文字規範。醫療器材說明書和標籤可以附加其他文種，但應以中文表述為準。醫療器材說明書和標籤中的文字、符號、表格、數字、圖形等應準確、清晰、規範。
To import medical device, it is necessary to apply to the Food and Drug Administration (NMPA) of the State Council for filing/registration of medical device in the name of a representative office established in China or a designated enterprise legal person within China as an agent.
Registration and filing of medical device products
- Registration and filing
．Category I: Filing management of medical device products
．Category II and Category III: Medical device is subject to product registration management.
- The applicant
．For overseas manufacturers of Category I medical devices, their representative offices in China or designated corporate legal persons in China shall be their agents to submit filing materials and the competent authorities of the country (region) where the filing person is located to the Food and Drug Administration of the State Council. Evidence that the medical device is approved for sale on the market.
．Overseas manufacturers of Category II and Category III medical devices shall submit registration application materials and registration applicants to the Food and Drug Administration of the State Council through their representative offices established in China or designated corporate legal persons in China as agents. Documents proving that the competent authority of the country (region) where the medical device is approved for sale on the market.
- Application webpage:
Category I https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207201300101
Category II &and Category III
https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204400101
- Validity period: The medical device registration certificate is valid for 5 years. If it is necessary to renew the registration after the expiry of the validity period, an application for renewal of the registration shall be submitted to the original registration department 6 months before the expiry of the validity period.
- The following materials should be submitted for filing of Category I medical device products and applying for the registration of Category II and Category III medical device products:
．Product risk analysis information;
．Product technical requirements;
．Product inspection report;
．Clinical evaluation information;
．Product brochures and label samples;
．Quality management system documents related to product development and production;
．Other information required to prove the safety and efficacy of the product.
- Note
．The medical device registration applicant and filing person shall be responsible for the authenticity of the submitted materials.
．For the filing of Category I medical device products, the filing person shall submit the filing materials to the food and drug supervision and administration department of the people’s government at the municipal level where the district is located.
Among them, the product inspection report can be the self-inspection report of the filer; the clinical evaluation data does not include the clinical trial report, and can be the data obtained through literature and the clinical use of similar products to prove that the medical device is safe and effective.
．To apply for the registration of Category II medical device products, the registration applicant should submit the registration application materials to the food and drug administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where it is located.
To apply for the registration of a Category III medical device product, the registration applicant shall submit the registration application materials to the food and drug administration under the State Council.
．The product inspection report in the application materials for the registration of Category II and Category III medical device products shall be the inspection report issued by the medical device inspection institution; the clinical evaluation data shall include the clinical trial report,
．The registration application shall transfer the registration application materials to the technical review agency within 3 working days from the date of acceptance. Decide. For those that meet the safety and effectiveness requirements, the registration shall be granted and a medical device registration certificate shall be issued; for those that do not meet the requirements, the registration shall not be granted and the reasons shall be explained in writing.
．For the filing of Category I of medical device products, clinical trials are not required. For the registration of Category II and Category III medical device products, clinical trials shall be conducted; however, clinical trials may be exempted under any of the following circumstances: the working mechanism is clear, the design is finalized, the production process is mature, and the same variety of medical devices that have been marketed The medical device has been used clinically for many years and has no serious adverse event records, and does not change its routine use; it can be proved that the medical device is safe and effective through non-clinical evaluation; through the analysis and evaluation of the data obtained from clinical trials or clinical use of the same variety of medical devices, it can be proved that the medical device is safe and effective. Prove that the medical device is safe and effective.
．If the clinical trials of Category III medical devices have relatively high risks to the human body, they shall be approved by the food and drug supervision and administration department of the State Council.
The catalogue of Category III medical devices with relatively high risks to humans in clinical trials shall be formulated, adjusted and published by the food and drug administration under the State Council.
Labels, Instructions
- Instructions should include the following:
．Product name, model, specification.
．The name, address, contact information and after-sales service unit of the registrant or filing person, and the name, address and contact information of the agent for imported medical device should also be indicated.
．The name, domicile, production address, contact information and production license number or production record certificate number of the production enterprise, and the entrusted production shall also be marked with the name, domicile, production address, production license number or production record certificate number of the entrusted enterprise.
．Medical device registration certificate number or filing certificate number.
．Number of product technical requirements.
．Product performance, main structural composition or ingredients, and scope of application.
．Contents of contraindications, precautions, warnings and prompts.
．Installation and use instructions or illustrations, medical device used by consumers themselves should also have special instructions for safe use
．Product care and maintenance methods, special storage and transportation conditions, methods.
．Date of manufacture, expiration date or expiration date.
．List of accessories, including accessories, accessories, replacement cycle of consumables and description of replacement methods.
．Explanation of graphics, symbols, abbreviations, etc. used on medical device labels.
．Date of preparation or revision of the manual.
．Other content that should be marked.
．For reusable medical devices, the handling procedures for reuse, including cleaning, disinfection, packaging, and sterilization methods, and the number of reuses or other limitations should be specified in the instructions.
- The relevant precautions, warnings and hints in the manual mainly include:
．The object used by the product.
．Potential Safety Hazards and Use Restrictions.
．The protective measures for operators and users, as well as emergency and corrective measures to be taken when an accident occurs during the correct use of the product.
．Necessary monitoring, evaluation and control means.
．Disposable products should be marked with single-use words or symbols, sterilized products should be marked with the sterilization method and the treatment method after the sterilization package is damaged, and the disinfection or sterilization method should be indicated if disinfection or sterilization is required before use.
．When the product needs to be installed or used in combination with other medical device, the requirements, usage methods and precautions for the combined use of the device should be indicated.
．In the process of use, the possible mutual interference with other products and the possible hazards.
．Adverse events that may occur during product use or ingredients or excipients contained in product ingredients that may cause side effects.
．Matters needing attention when disposing of medical device, if the product needs to be disposed of after use, the corresponding disposal method should be indicated.
．According to the characteristics of the product, the operator and user should be prompted to pay attention to other matters.
- The label shall include the following:
．Product name, model, specification
．The name, domicile and contact information of the registrant or filing person, and the name, domicile and contact information of the agent for imported medical device shall also be indicated
．Medical device registration certificate number or filing certificate number
．The name, domicile, production address, contact information and production license number or production record certificate number of the production enterprise. If the production is entrusted, the name, domicile, production address, production license number or production record certificate number of the entrusted enterprise shall also be marked
．Date of manufacture, expiry date or expiration date
．Power connection conditions, input power
．Graphics, symbols and other related content that should be marked according to product characteristics
．Necessary warnings and precautions
．Special storage, handling conditions or instructions
．For medical device that has damage or negative impact on the environment during use, the label should contain warning signs or Chinese warning instructions
．For medical device with radiation or radiation, the label should contain warning signs or Chinese warning instructions
．If the medical device label cannot fully indicate the above content due to the limited location or size, at least the product name, model, specification, production date and use period or expiration date should be marked, and clearly marked in the label: For other details, please refer to the instruction manual.
- Instructions and labels of medical devices shall not contain the following contents:
．Contains: the best curative effect, guaranteed cure, inclusive cure, radical cure, immediate effect, completely free of toxic and side effects, etc.
．Contains: the highest technology, the most scientific, the most advanced, the best and other absolute language and representation.
．Explain the cure rate or efficiency.
．Compared with the efficacy and safety of other enterprise products.
．Contains: insurance company insurance, invalid refund and other promise language.
．Using the name or image of any unit or individual as proof or recommendation
．Contains misleading statements that make people feel that they have suffered from a certain disease, or misunderstand the statement that a certain disease will be developed or aggravated by not using the medical device, and other false, exaggerated, and misleading content.
．Other content prohibited by laws and regulations.
- Others
．The medical device instructions shall be submitted by the registration applicant or filing person to the food and drug supervision and administration department for review or filing when the medical device is registered or filed, and the contents of the submitted instructions shall be consistent with other registration or filing materials.
．The description of disease names, professional terms, diagnosis and treatment process and results in medical device manuals and labels shall use special vocabulary uniformly issued or standardized by the state, and the units of measurement shall comply with the relevant national standards.
．The minimum sales unit of medical device should be accompanied by instructions, and users of medical device should use the medical device in accordance with the instructions.
．The product name should use the generic name, and the generic name should comply with the naming rules for medical devices formulated by the State Food and Drug Administration. The product names of Category II and Category III medical devices should be consistent with the product names in the medical device registration certificate, and the product names should be clearly marked in a prominent position on the instructions and labels.
．The instructions and labels of medical device should be written in Chinese, and the use of Chinese should comply with the national language standards. Instructions and labels of medical device may be attached in other languages, but the Chinese language shall prevail. The words, symbols, tables, figures, graphics, etc. in the instructions and labels of medical device shall be accurate, clear and standardized.
【參考連結】
https://gkml.samr.gov.cn/nsjg/bgt/202106/t20210629_331738.html
HLF-TW-55
請問在中國有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
瑞旭集團
https://www.cirs-group.com/foodcn
天健華成
HLF-TW-60
經過核准登記的醫療器材，進口到中國要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved medical devices into China? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
進口醫療器材需以中國境內設立的代表機構名義或指定中國境內的企業法人作為代理人，向國務院食品藥品監督管理部門(NMPA)申請醫療器材產品備案/註冊，進口前於海關總署申報，無銷售許可證。
海關總署申報
1.申請條件：在海關註冊登記的企業。
2.申請資料：
．證明進出口貨物的實際情況的資料，包括進出口貨物的品名、規格、用途、產地、貿易方式等。
．合約複本1份(電子版或紙質版)
．發票複本1份(電子版或紙質版)
．裝箱清單複本1份(電子版或紙質版)
．提（運）單複本1份(電子版或紙質版)
．代理報關授權委託協議（蓋章）原件1份(電子版或紙質版)
．進口醫療器材還應提供，附有醫療器材註冊登記表的醫療器材註冊證或經備案的證明文件；進口捐贈醫療器材還需提供加蓋印章的境外捐贈醫療器材產品備案申請和捐贈醫療器材產品一覽表。
．進出口所需的許可證件及隨附憑證。
．海關總署規定的其他進出口憑證。
3.申請網頁：https://online.customs.gov.cn
4.辦理流程：
．向海關傳送電子報關單及隨附憑證。
．進出口貨物的收發貨人以自己的名義，向海關申報的，報關單當由進出口貨物收發貨人簽名蓋章，並隨附有關憑證。
．報關企業接受進出口貨物的收發貨人委託，以自己的名義或以委託人的名義向海關申報的，當向海關提交由委託人簽署的授權委託書，並按照委託書的授權範圍辦理有關海關手續。
．進口貨物的收貨人當自運輸工具申報進境之日起十四日內，出口貨物的發貨人除海關特准的外當在貨物運抵海關監管區後、裝貨的二十四小時以前，向海關申報。
．商品檢驗：海關根據有關工作規範、企業信用類別、產品風險等級，判別是否需要實施現場檢驗及是否需要對產品實施抽樣檢測。
．法定檢驗的進口商品經檢驗涉及人身財產安全、健康、環境保護項目不合格的，由海關責令當事人銷毀或者退運；其他項目不合格的，可以在海關監督下進行技術處理，經重新檢驗合格的，方可銷售或者使用。海關對檢驗不合格的成套設備及其材料，簽發不准安裝使用通知書。經技術處理，並經海關重新檢驗合格的，方可安裝使用。
．法定檢驗的出口商品經海關檢驗或者口岸查驗不合格的，可以在海關監督下進行處理，經重新檢驗合格的，方准出口；不能進行技術處理或者技術處理後重新檢驗仍不合格的，不准出口。
5.備註
．進口貨物的收貨人、出口貨物的發貨人當向海關如實申報，交驗進出口許可證件和有關憑證。國家限制進出口的貨物，沒有進出口許可證件的，不予放行。
．進口貨物的收貨人超過前款規定期限向海關申報的，由海關徵收滯報金。
To import medical device, it is necessary to apply for the record/registration of medical device to the Food and Drug Administration of the State Council (NMPA) in the name of a representative office established in China or to designate an enterprise legal person in China as an agent, and declare to the General Administration of Customs before importing.No sales license.
Declaration of the General Administration of Customs
- Application requirements: Enterprises registered with the customs.
- Application information:
．Documents proving the actual situation of imported and exported goods, including the name, specification, use, origin, trade method, etc. of imported and exported goods.
．1 copy of the contract (electronic or paper version)
．1 copy of the invoice (electronic or paper version)
．1 copy of packing list (electronic or paper version)
．1 copy of the bill of lading (shipping) (electronic or paper version)
．1 original copy of the agency declaration authorization agreement (stamped) (electronic or paper version)
．Imported medical device should also provide a medical device registration certificate with a medical device registration form or a documented certificate; imported donated medical device should also provide a stamped overseas donated medical device product filing application and a list of donated medical device products .
．Permits and accompanying documents required for import and export.
．Other import and export documents stipulated by the General Administration of Customs.
- URL: https://online.customs.gov.cn
- Process:
．Send electronic customs declaration and accompanying documents to customs.
．If the consignee or consignor of import and export goods declares to the customs in his own name, the declaration form shall be signed and sealed by the consignee and consignee of import and export goods, and the relevant documents shall be attached.
．If a customs declaration enterprise accepts the entrustment of the consignee and consignor of import and export goods and declares to the customs in its own name or in the name of the client, it shall submit a power of attorney signed by the client to the customs, and handle the relevant matters according to the scope of authorization of the power of attorney. customs formalities.
．The consignee of imported goods shall be within 14 days from the date when the means of transport declares entry, and the consignor of exported goods shall be within 24 hours after the goods arrive in the customs supervision area, unless otherwise approved by the customs. Customs declaration.
．Commodity inspection: The customs judges whether on-site inspection is necessary and whether it is necessary to conduct sampling inspection of products according to relevant work specifications, enterprise credit categories, and product risk levels.
．If the imported goods subject to statutory inspection are found to be unqualified in terms of personal and property safety, health, and environmental protection, the customs shall order the parties concerned to destroy or return the goods; if other items fail to pass the inspection, they may undergo technical treatment under the supervision of the customs, and those that pass the re-inspection shall before it can be sold or used.
The Customs shall issue a Notice of Prohibition of Installation and Use to the complete set of device and its materials that fail the inspection. After technical treatment and re-inspection by the customs, it can be installed and used.
．If the export commodities subject to statutory inspection fail to pass the customs inspection or port inspection, they may be handled under the supervision of the customs. If they pass the re-inspection, they will be allowed to export; if the technical treatment cannot be carried out or the re-inspection is still unqualified after the technical treatment, the export is not allowed. Export.
- Note
．The consignee of imported goods and the consignor of exported goods shall declare truthfully to the customs, and submit the import and export licenses and relevant certificates for inspection.
The goods whose import and export are restricted by the state will not be released without the import and export license.
．If the consignee of the imported goods declares to the customs beyond the time limit specified in the preceding paragraph, the customs shall levy a fine for delayed declaration.
【參考連結】
http://www.customs.gov.cn/chengdu_customs/519436/519438/2099353/index.html
HLF-TW-70
中國醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
醫療器材註冊需檢附檢驗資料
- 綜述資料
．產品描述：器材及操作原理描述、型號規格、包裝說明、研發歷程、與同類和/或前代產品的參考和比較。
．適用範圍和禁忌症：適用範圍、預期使用環境、適用人群、禁忌症。
．申報產品上市歷史：上市情況、不良事件和召回、銷售、不良事件及召回率。
．其他需說明的內容
- 非臨床資料
．產品風險管理資料：風險分析、風險評價、風險控制、任何一個或多個剩餘風險的可接受性評定、與產品受益相比，綜合評價產品風險可接受。
．醫療器材安全和性能基本原則清單：一般原則、臨床評價、化學、物理和生物學特性、滅菌和微生物污染、環境和使用條件、對電氣、機械和熱風險的防護、有源醫療器材及與其連接的醫療器材、含有軟體的醫療器材以及獨立軟體、具有診斷或測量功能的醫療器材、說明書和標籤、輻射防護、對非專業用戶使用風險的防護、含有生物源材料的醫療器材、適用於醫療器材的基本原則、輻射防護、植入醫療器材的特殊要求、提供能量或物質的醫療器材對患者或使用者的風險防護、含有藥物成分的組合產品。
．產品技術要求及檢驗報告：申報產品適用標準情況、產品技術要求、產品檢驗報告。
．研究資料：化學和物理性能研究、電氣系統安全性研究、輻射安全研究、軟體研究、生物學特性研究、生物源材料的安全性研究、清潔消毒滅菌研究、動物試驗研究證明產品安全性/有效性的其他研究資料。
．非臨床文獻：與申報產品相關的已發表的非臨床研究（如屍體研究、生物力學研究等）文獻/書目列表。
．穩定性研究：貨架有效期、使用穩定性、運輸穩定性。
- 臨床評價資料
．臨床評價資料：產品描述和研發背景、臨床評價路徑等
4.產品說明書和標籤樣稿
．產品說明書
．標籤樣稿
5.質量管理體系文件
．生產製造信息：產品描述、生產器材或其部件的所有地址和聯絡信息；外包生產、重要組件或原材料的生產（如動物組織和藥品）、關鍵工藝過程、滅菌等情況的所有重要供應商名稱和地址(如果適用)。
．質量管理體系程序：包括質量手冊、質量方針、質量目標和文件及記錄控製程序。
．管理職責程序：闡述質量方針、策劃、職責/權限/溝通和管理評審，對建立和維護質量管理體系形成管理保證文件的程序。
．資源管理程序：實施和維護質量管理體系所形成足夠資源（包括人力資源、基礎設施和工作環境）供應文件的程序。
．產品實現程序：設計和開發程序、採購程序、生產和服務控制程序、監視和測量裝置控制程序。
．質量管理體系的測量、分析和改進程序：監視、測量、分析和改進以確保產品和質量管理體系的符合性，並保持質量管理體係有效性的文件的程序。
．其他質量體系程序信息。
．質量管理體系核查文件。
- 醫療器材安全和性能基本原則
．安全和性能的通用基本原則
．臨床評價
．滅菌和微生物污染
．環境和使用條件
．對電氣、機械和熱風險的防護
．有源醫療器材及與其連接的醫療器材
．含有軟件的醫療器材以及獨立軟件
．具有診斷或測量功能的醫療器材
．說明書和標籤
．輻射防護
．對非專業用戶使用風險的防護
．含有生物源材料的醫療器材
．化學、物理和生物學特性
．植入醫療器材的特殊要求
．提供能量或物質的醫療器材對患者或使用者的風險防護
．含有藥物成分的組合產品
Medical device registration requires inspection data
- General information
．Product Description: Description of device and operating principles, model specifications, packaging instructions, research and development history, reference and comparison with similar and/or previous generation products.
．Scope of application and contraindications: scope of application, intended use environment, applicable population, contraindications.
．Report product listing history: listing status, adverse events and recalls, sales, adverse events and recall rates.
．Others
- Non-clinical data
．Product risk management information: risk analysis, risk evaluation, risk control, acceptability assessment of any one or more residual risks, and comprehensive evaluation of product risk acceptability compared to product benefits.
．List of Fundamental Principles of Medical Device Safety and Performance: General Principles, Clinical Evaluation, Chemical, Physical and Biological Characteristics, Sterilization and Microbiological Contamination, Environmental and Conditions of Use, Protection against Electrical, Mechanical and Thermal Risks, Active Medical Devices and Their Connections medical devices containing software and stand-alone software, medical devices with diagnostic or measuring functions, instructions and labels, radiation protection, protection against the risk of use by non-professional users, medical devices containing biologically derived materials, suitable for medical devices Basic principles of radiation protection, special requirements for implantable medical devices, risk protection to patients or users of medical devices that provide energy or substances, and combination products containing pharmaceutical ingredients.
．Product technical requirements and inspection reports: the applicable standards for the declared products, product technical requirements, and product inspection reports.
．Research materials: chemical and physical performance research, electrical system safety research, radiation safety research, software research, biological property research, safety research of biologically sourced materials, cleaning, disinfection and sterilization research, animal test research to prove the safety/effectiveness of the product other research data.
．Non-clinical literature: A list of literature/bibliography of published non-clinical studies (such as cadaveric studies, biomechanical studies, etc.) related to the declared product.
．Stability research: shelf life, use stability, transportation stability.
- Clinical evaluation data
．Clinical evaluation data: product description and research and development background, clinical evaluation path, etc.
- Product manual and label sample
．Product manual
．Label sample
- Quality management system documentation
．Manufacturing Information: Product description, all addresses and contact information for manufacturing device or its components; names and address (if applicable).
．Quality management system procedures: including quality manual, quality policy, quality objectives and document and record control procedures.
．Management Responsibilities Procedure: Describe the quality policy, planning, responsibilities/authorities/communication and management review, and form management assurance documents for establishing and maintaining the quality management system.
．Resource Management Procedures: Procedures for implementing and maintaining the documentation for the provision of adequate resources (including human resources, infrastructure and work environment) resulting from the quality management system.
．Product realization procedures: design and development procedures, procurement procedures, production and service control procedures, monitoring and measurement device control procedures.
．Quality Management System Measurement, Analysis, and Improvement Procedures: Procedures for monitoring, measuring, analyzing, and improving to ensure product and quality management system compliance, and to maintain documentation of the quality management system effectiveness.
．Additional quality system program information.
．Quality management system verification documents.
- Basic principles of medical device safety and performance
．General basic principles of safety and performance
．Clinical evaluation
．Sterilization and microbiological contamination
．Environment and Conditions of Use
．Protection against electrical, mechanical and thermal risks
．Active medical devices and connected medical devices
．Medical devices that contain software and stand-alone software
．Medical devices with diagnostic or measurement functions
．Instructions & Labels
．Radioprotection
．Protection against the risk of non-professional users
．Medical Devices Containing Biosourced Materials
．Chemical, Physical and Biological Properties
．Particular requirements for implantable medical devices
．Risk protection for patients or users of medical devices that provide energy or matter
．Combination products containing pharmaceutical ingredients
【參考連結】
https://www.nmpa.gov.cn/ylqx/ylqxggtg/20210930155134148.html
HLF-TW-75
中國醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
需為中國境內認可之檢驗中心之檢驗資料。
HLF-TW-77
請問在中國有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
廣東省醫療器材質量監督檢驗所
浙江省醫療器材檢驗研究院
北京市醫療器材檢驗研究院
HLF-TW-80
外國子公司進口醫療器材後，如果委託中國的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports medical devices and entrusts a distributor in China to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
需要，從事醫療器材經營活動需為當地企業向所在地設區的市級負責藥品監督管理的部門(市政府)取得經營許可/備案，其中第一類醫療器材不需要經營許可和備案、第二類需完成備案、第三類需獲得許可。
產品責任
1.醫療器材生產企業應建立健全醫療器材召回管理制度，收集醫療器材安全相關信息，對可能的缺陷產品進行調查、評估，及時召回缺陷產品。
2.進口醫療器材的境外製造廠商在中國境內指定的代理人應將僅在境外實施醫療器材召回的有關信息及時報告國家食品藥品監督管理總局；凡涉及在境內實施召回的，中國境內指定的代理人應實施。
3.醫療器材經營企業、使用單位應積極協助醫療器材生產企業對缺陷產品進行調查、評估，主動配合生產企業履行召回義務，按照召回計劃及時傳達、反饋醫療器材召回信息，控制和收回缺陷產品。
4.醫療器材經營企業、使用單位發現其經營、使用的醫療器材可能為缺陷產品的，應立即暫停銷售或者使用該醫療器材，及時通知醫療器材生產企業或者供貨商，並向所在地省、自治區、直轄市食品藥品監督管理部門報告；使用單位為醫療機構的，還應同時向所在地省、自治區、直轄市衛生行政部門報告。
5.醫療器材經營企業、使用單位所在地省、自治區、直轄市食品藥品監督管理部門收到報告後，應及時通報醫療器材生產企業所在地省、自治區、直轄市食品藥品監督管理部門。
- 對存在缺陷的醫療器材產品進行評估的主要內容包括：
．產品是否符合強制性標準、經註冊或者備案的產品技術要求。
．在使用醫療器材過程中是否發生過故障或者傷害。
．在現有使用環境下是否會造成傷害，是否有科學文獻、研究、相關試驗或者驗證能夠解釋傷害發生的原因。
．傷害所涉及的地區範圍和人群特點。
．對人體健康造成的傷害程度。
．傷害發生的概率。
．發生傷害的短期和長期後果。
．其他可能對人體造成傷害的因素。
7.根據醫療器材缺陷的嚴重程度，醫療器材召回分為：
．一級召回：使用該醫療器材可能或者已經引起嚴重健康危害的。
．二級召回：使用該醫療器材可能或者已經引起暫時的或者可逆的健康危害的。
．三級召回：使用該醫療器材引起危害的可能性較小但仍需要召回的。
．醫療器材生產企業應根據具體情況確定召回級別並根據召回級別與醫療器材的銷售和使用情況，科學設計召回計劃並組織實施。
8.生產企業作出醫療器材召回決定的，一級召回應在1日內，二級召回應在3日內，三級召回應在7日內，通知到有關醫療器材經營企業、使用單位或者告知使用者。召回通知應包括以下內容：
．召回醫療器材名稱、型號規格、批次等基本信息。
．召回的原因。
．召回的要求，如立即暫停銷售和使用該產品、將召回通知轉發到相關經營企業或者使用單位等。
．召回醫療器材的處理方式。
- 醫療器材生產企業對召回醫療器材的處理應有詳細的記錄，並向醫療器材生產企業所在地省、自治區、直轄市食品藥品監督管理部門報告，記錄應保存至醫療器材註冊證失效後5年，第一類醫療器材召回的處理記錄應保存5年。對通過警示、檢查、修理、重新標籤、修改並完善說明書、軟件更新、替換、銷毀等方式能夠消除產品缺陷的，可以在產品所在地完成上述行為。需要銷毀的，應在食品藥品監督管理部門監督下銷毀。
- 醫療器材生產企業應在召回完成後10個工作日內對召回效果進行評估，並向所在地省、自治區、直轄市食品藥品監督管理部門提交醫療器材召回總結評估報告。
Yes, to engage in medical device business activities, it is necessary for local enterprises to obtain a business license/filing from the department responsible for drug supervision and management at the municipal level (municipal government) with districts where they are located. The filing needs to be completed, and Category III needs to be licensed.
Product Liability
- Medical device manufacturers should establish and improve the medical device recall management system, collect information on medical device safety, investigate and evaluate possible defective products, and recall defective products in a timely manner.
- The agent designated by the overseas manufacturer of imported medical device in China shall promptly report the relevant information of the recall of medical device only overseas to the State Food and Drug Administration; if the recall in China is involved, the agent designated in China shall people should implement.
- Medical device operating enterprises and users should actively assist medical device manufacturers to investigate and evaluate defective products, actively cooperate with manufacturers to fulfill recall obligations, timely communicate and feedback medical device recall information in accordance with the recall plan, and control and recover defective products.
- If a medical device operating enterprise or user unit finds that the medical device it operates or uses may be a defective product, it should immediately suspend the sale or use of the medical device, promptly notify the medical device manufacturer or supplier, and report to the province or autonomous region where it is located. , the municipal food and drug supervision and administration department; if the user is a medical institution, it should also report to the health administrative department of the province, autonomous region, or municipality directly under the Central Government at the same time.
- After receiving the report, the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device operating enterprise or user unit is located shall promptly notify the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located.
- The main contents of the evaluation of defective medical device products include:
．Whether the product complies with mandatory standards, registered or filed product technical requirements.
．Whether there has been any malfunction or injury during the use of medical device.
．Whether it will cause harm in the current use environment, and whether there is scientific literature, research, relevant experiments or verification that can explain the reasons for the harm.
．The scope of the area and the characteristics of the population involved in the injury.
．The degree of harm to human health.
．The probability of injury occurring.
．Short-term and long-term consequences of injury.
．Other factors that may cause harm to the human body.
- According to the severity of medical device defects, medical device recalls are divided into:
．Category I recall: The use of the medical device may or has caused serious health hazards.
．Category II recall: The use of the medical device may or has caused temporary or reversible health hazards.
．Category III recall: The use of the medical device is less likely to cause harm but still needs to be recalled.
．Medical device manufacturers should determine the recall level according to the specific situation and scientifically design recall plans and organize their implementation according to the recall level and the sales and use of medical device.
- If a manufacturer makes a decision to recall medical device, the first-level recall should be within 1 day, the second-level recall should be within 3 days, and the third-level recall should be within 7 days, and the relevant medical device operators, user units or users should be notified. The recall notice should include the following:
．Basic information such as the name, model specification, batch, etc. of the recalled medical device.
．Reason for recall.
．Recall requirements, such as immediately suspending the sale and use of the product, forwarding the recall notice to the relevant operating enterprise or user unit, etc.
．How to dispose of recalled medical devices.
- The medical device manufacturer should keep detailed records on the handling of recalled medical devices, and report to the food and drug supervision and administration department of the province, autonomous region, or municipality where the medical device manufacturer is located. The records should be kept for 5 years after the medical device registration certificate expires.
The handling records for the recall of Category I medical devices shall be kept for 5 years. Where product defects can be eliminated by means of warning, inspection, repair, relabeling, modification and improvement of manuals, software update, replacement, destruction, etc., the above actions may be completed at the location of the product. Those that need to be destroyed shall be destroyed under the supervision of the food and drug administration. - The medical device manufacturer shall evaluate the recall effect within 10 working days after the recall is completed, and submit the medical device recall summary evaluation report to the food and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located.
【參考連結】https://gkml.samr.gov.cn/nsjg/fgs/202203/t20220322_340682.html
https://gkml.samr.gov.cn/nsjg/bgt/202106/t20210629_331728.html
HLF-TW-85
請問在中國有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
金誠同達律師事務所
https://www.jtn.com/CN/index.aspx?PageUrl=index
中倫律師事務所
Email：pek4ww@evershinecpa.com
或
北京永辉协同网路咨询有限公司 Evershine.pek
地址:北京市东域区东直门外大街48号东方银座公寓C栋17D
地铁2号线东直门站出口,也是机场线最后一站
驻在北京业务联系人:李高斌经理
或
联络人：陈中成 首席合伙人/会计师/专利师
手机：+886-933-920-199
skype: daleccchen
wechat: EvershiineCPA
电话：+886-2-2717-0515 分机:100
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