China Medical Device Regulation QA

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HLF-TW-10

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：

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

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：

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

．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

http://banshi.beijing.gov.cn/pubtask/task/1/110109000000/55bbc66a-12b9-49ee-bf1d-5fc6ad5e5267.html?locationCode=110109000000

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

http://www.gainder.com/

深圳市明邦財稅集團有限公司

http://www.mingbang123.com

HLF-TW-30

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：

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

．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.

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

http://www.zj-tiansong.com/

北京盈欣科儀醫療器材有限公司

http://med1625.yixie8.com/

HLF-TW-40

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：

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

https://www.zhuceabc.cn/

HLF-TW-50

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：

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

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.

．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.

．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.

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.

．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

．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

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

．Other content prohibited by laws and regulations.

Others

．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.

【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

https://www.zhuceabc.cn/

HLF-TW-60

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：

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

http://online.customs.gov.cn/static/pages/index.html?guidebookUrl=/static/pages/guides/000629002001/000629002001.html&applyUrl=https%3A%2F%2Fsc.chinaport.gov.cn%2Fdeskserver%2Fsw%2FdeskIndex%3Fmenu_id%3Ddec001&userType=0&systemType=WEB&taskCode=11100000000014154E1000629002001&flag=false

HLF-TW-70

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

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

http://gdmdt.gd.gov.cn/

浙江省醫療器材檢驗研究院

https://www.mdst.org.cn/

北京市醫療器材檢驗研究院

https://www.bimt.org.cn/

HLF-TW-80

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：

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.

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

https://www.zhonglun.com/

Contact Us

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E-mail: pek4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of China (GMT+8)
The Engaging Manager from Headquarter
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WeChat: JheHanKo
skype: dk5k6c045

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Evershine Potential Serviceable City (2 months preparatory period):
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(version: 2022/03)

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