-->
New Regulations on Supervision and Administration of Medical Devices issued by the National Medical Products Administration
2021-9-4

Order of the State Council of the people's Republic of China

No. 739

The regulations on the supervision and administration of medical devices, which were revised and adopted at the 119th executive meeting of the State Council on December 21, 2020, are hereby promulgated and shall enter into force as of June 1, 2021.

Premier Li Keqiang

February 9, 2021

Regulations on the supervision and administration of medical devices

(promulgated by order No. 276 of the State Council of the people's Republic of China on January 4, 2000, revised and adopted at the 39th executive meeting of the State Council on February 12, 2014, revised according to the decision of the State Council on Amending the regulations on the supervision and administration of medical devices on May 4, 2017, and revised and adopted at the 119th executive meeting of the State Council on December 21, 2020)

Chapter I General Provisions

Article 1 These Regulations are formulated to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of medical device industry.

Article 2 These Regulations shall apply to the research, production, operation and use of medical devices and their supervision and administration within the territory of the people's Republic of China.

Article 3 the drug regulatory department under the State Council shall be responsible for the supervision and administration of medical devices throughout the country.

The relevant departments under the State Council shall be responsible for the supervision and administration related to medical devices within their respective functions and responsibilities.

Article 4 the local people's governments at or above the county level shall strengthen their leadership over the supervision and administration of medical devices in their respective administrative regions, organize and coordinate the supervision and administration of medical devices and the response to emergencies in their respective administrative regions, strengthen the capacity-building of supervision and administration of medical devices, and provide guarantee for the safety of medical devices.

The drug supervision and administration departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices in their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration related to medical devices within their respective functions and responsibilities.

Article 5 the supervision and management of medical devices shall follow the principles of risk management, whole process control, scientific supervision and social co governance.

Article 6 the State implements classified management of medical devices according to the degree of risk.

The first category is medical devices with low risk, and the implementation of routine management can ensure their safety and effectiveness.

The second category is medical devices with moderate risk and need to be strictly controlled and managed to ensure their safety and effectiveness.

The third category is medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.

In evaluating the risk degree of medical devices, the expected purpose, structural characteristics, use methods and other factors of medical devices shall be considered.

The drug regulatory department under the State Council is responsible for formulating the classification rules and classification catalogue of medical devices, timely analyzing and evaluating the risk changes of medical devices according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalogue. In formulating and adjusting the classification rules and classification catalogue, the opinions of the medical device registrants, filers, production and operation enterprises, users and industry organizations shall be fully listened to, and the practice of international medical device classification shall be referred to. The classification rules and catalogue of medical devices shall be published to the public.

Article 7 medical device products shall meet the mandatory national standards for medical devices; If there is no mandatory national standard, it shall comply with the mandatory industrial standards for medical devices.

Article 8 the State formulates plans and policies for the medical device industry, brings the innovation of medical devices into the focus of development, gives priority to the evaluation and approval of innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes the high-quality development of the medical device industry. The drug regulatory department under the State Council shall cooperate with relevant departments under the State Council to implement the national medical device industry planning and guidance policies.

Article 9 the State shall improve the innovation system of medical devices, support the basic research and Application Research of medical devices, promote the promotion and application of new technologies of medical devices, and provide support in science and technology project approval, financing, credit, bidding procurement, medical insurance, etc. Support enterprises to establish or jointly establish research and development institutions, encourage enterprises to cooperate with colleges and universities, scientific research institutes and medical institutions to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the independent innovation ability of medical devices.

Article 10 the State shall strengthen the informatization construction of medical device supervision and management, improve the online government service level, and provide convenience for administrative licensing and filing of medical devices.

Article 11 medical device industry organizations shall strengthen industry self-discipline, promote the construction of integrity system, urge enterprises to carry out production and business activities according to law, and guide enterprises to be honest and trustworthy.

Article 12 units and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with the relevant provisions of the state.

Chapter II Registration and filing of medical devices

Article 13 class I medical devices shall be subject to product filing management, and class II and class III medical devices shall be subject to product registration management.

The registrants and recorders of medical devices shall strengthen the quality management of the whole life cycle of medical devices and bear responsibility for the safety and effectiveness of traditional Chinese medical devices in the whole process of development, production, operation and use according to law.

Article 14 the following materials shall be submitted for the filing of class I medical devices and the application for the registration of class II and class III medical devices:

(1) Product risk analysis data;

(2) Product technical requirements;

(3) Product inspection report;

(4) Clinical evaluation data;

(5) Product manual and label sample;

(6) Quality management system documents related to product development and production;

(7) Other materials required to prove the safety and effectiveness of the product.

The product inspection report shall meet the requirements of the drug regulatory department under the State Council. It can be the self inspection report of the applicant and recorder of medical device registration, or the inspection report issued by a qualified medical device inspection institution entrusted.

Those who are exempted from clinical evaluation in accordance with the provisions of Article 24 of these regulations may be exempted from submitting clinical evaluation materials.

The medical device registration applicant and the recorder shall ensure that the materials submitted are legal, true, accurate, complete and traceable.

Article 15 for the filing of class I medical devices, the filing person shall submit the filing materials to the drug regulatory department of the local municipal people's government divided into districts.

For the overseas filer who exports class I medical devices to China, the domestic enterprise legal person designated by him shall submit the filing materials and the supporting documents that the competent department of the country (region) where the filer is located permits the listing and sales of the medical devices to the drug regulatory department under the State Council. For innovative medical devices that are not listed abroad, the supporting documents that the competent department of the country (region) where the filing person is located allows the medical devices to be listed and sold may not be submitted.

The filing person shall complete the filing after submitting the filing materials in accordance with the provisions of these regulations to the Department in charge of drug supervision and administration. The Department in charge of drug supervision and administration shall, within 5 working days from the date of receiving the filing materials, publish the filing related information to the public through the online government service platform of the drug supervision and administration department under the State Council.

In case of any change in the matters specified in the filing materials, it shall change the filing to the original filing department.

Article 16 to apply for the registration of class II medical devices, the registration applicant shall submit the registration application materials to the drug regulatory 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 class III medical devices, the registration applicant shall submit the registration application materials to the drug regulatory department under the State Council.

For an overseas registration applicant who exports class II and class III medical devices to China, the domestic enterprise legal person designated by him shall submit the registration application materials and the supporting documents of the competent department of the country (region) where the registration applicant is located allowing the medical devices to be sold on the market to the drug regulatory department under the State Council. For innovative medical devices that are not listed abroad, the certification documents that the competent department of the country (region) where the registration applicant is located allows the medical devices to be listed and sold may not be submitted.

The drug regulatory department under the State Council shall stipulate the procedures and requirements for the registration examination of medical devices, and strengthen the supervision and guidance of the registration examination of the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government.

Article 17 the drug regulatory department that accepts the registration application shall examine the safety and effectiveness of medical devices and the ability of the registration applicant to ensure the safety and effective quality management of medical devices.

The drug regulatory department accepting the registration application shall, within 3 working days from the date of accepting the registration application, transfer the registration application materials to the technical evaluation institution. After completing the technical review, the technical review institution shall submit the review opinions to the drug regulatory department that accepts the registration application as the basis for examination and approval.

If the drug regulatory department accepting the registration application considers it necessary to verify the quality management system when organizing the technical review of medical devices, it shall organize the verification of the quality management system.

Article 18 the drug regulatory department that accepts the registration application shall make a decision within 20 working days from the date of receiving the review opinions. For those who meet the conditions, registration is approved and a medical device registration certificate is issued; Those who do not meet the conditions shall not be registered and the reasons shall be explained in writing.

The drug regulatory department accepting the registration application shall publish the registration related information to the public through the online government service platform of the drug regulatory department under the State Council within 5 working days from the date when the medical device is approved for registration.

Article 19 for medical devices urgently needed for the treatment of rare diseases, serious life-threatening diseases without effective means of treatment and public health events, the drug regulatory department that accepts the registration application may make a conditional approval decision and specify the relevant matters in the medical device registration certificate.

In the event of a particularly major public health emergency or other emergency that seriously threatens public health, the competent department of health under the State Council shall put forward suggestions for the emergency use of medical devices according to the needs of preventing and controlling the event, and the medical devices can be used urgently within a certain range and time limit after being demonstrated and approved by the drug regulatory department under the State Council.

Article 20 the registrant and recorder of medical devices shall perform the following obligations:

(1) Establish a quality management system suitable for products and maintain effective operation;

(2) Formulate post listing research and risk control plan and ensure its effective implementation;

(3) Carry out adverse event monitoring and re evaluation according to law;

(4) Establish and implement product traceability and recall system;

(5) Other obligations stipulated by the drug regulatory department under the State Council.

The domestic enterprise legal person designated by the overseas medical device registrant and recorder shall assist the registrant and recorder in performing the obligations specified in the preceding paragraph.

Article 21 if there are substantial changes in the design, raw materials, production process, scope of application and use methods of class II and class III registered medical devices, which may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for handling the change of registration procedures; Other changes shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council.

Article 22 the registration certificate of medical devices shall be valid for 5 years. If it is necessary to renew the registration at the expiration of the validity period, an application for renewal of registration shall be submitted to the original registration department 6 months before the expiration of the validity period.

Except for the circumstances specified in paragraph 3 of this article, the drug regulatory department that receives the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed to have been granted.

Under any of the following circumstances, the registration shall not be renewed:

(1) Failing to apply for renewal of registration within the specified time limit;

(2) The mandatory standards for medical devices have been revised, and the medical devices applying for continuous registration cannot meet the new requirements;

(3) The medical devices approved with conditions fail to complete the items specified in the medical device registration certificate within the specified time limit.

Article 23 for the newly developed medical devices that have not been listed in the classification catalogue, the applicant may directly apply for product registration in accordance with the provisions of these Regulations on the registration of class III medical devices, It may also judge the product category according to the classification rules and apply to the drug regulatory department under the State Council for category confirmation, and then apply for product registration or product filing in accordance with the provisions of these regulations.

In case of directly applying for the registration of class III medical devices, the drug regulatory department under the State Council shall determine the category according to the risk degree, and timely include the medical devices approved for registration into the classified catalogue. If the application category is confirmed, the drug regulatory department under the State Council shall determine the category of the medical device and inform the applicant within 20 working days from the date of accepting the application.

Article 24 clinical evaluation shall be conducted for the registration and filing of medical devices; However, if one of the following conditions is met, the clinical evaluation can be exempted:

(1) The working mechanism is clear, the design is finalized, the production process is mature, the medical devices of the same type that have been on the market for many years without serious adverse event records, and do not change the routine use;

(2) Others that can prove the safety and effectiveness of the medical device through non clinical evaluation.

The drug regulatory department under the State Council shall formulate guidelines for clinical evaluation of medical devices.

Article 25 in the clinical evaluation of medical devices, the safety and effectiveness of medical devices can be proved by carrying out clinical trials, or by analyzing and evaluating the clinical literature and clinical data of the same type of medical devices according to the product characteristics, clinical risks, existing clinical data, etc.

According to the provisions of the drug regulatory department under the State Council, when conducting the clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the safety and effectiveness of the products, clinical trials shall be carried out.

Article 26 clinical trials of medical devices shall be conducted in clinical trial institutions with corresponding conditions in accordance with the requirements of the standard for the quality management of clinical trials of medical devices, and shall be filed with the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government where the clinical trial sponsor is located. The drug regulatory department accepting the clinical trial filing shall inform the drug regulatory department and the competent health department at the same level of the place where the clinical trial institution is located.

Medical device clinical trial institutions shall implement filing management. The conditions that a medical device clinical trial institution should meet, as well as the filing management measures and clinical trial quality management standards, shall be formulated and published by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.

The State supports medical institutions to carry out clinical trials, brings the evaluation of clinical trial conditions and capabilities into the grade evaluation of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.

Article 27 If the clinical trial of class III medical devices has a high risk to human body, it shall be approved by the drug regulatory department under the State Council. When examining and approving clinical trials, the drug regulatory department under the State Council shall make a comprehensive analysis of the equipment, professionals and other conditions of the institution to undertake clinical trials of medical devices, the risk degree of the medical devices, the implementation plan of clinical trials, the comparative analysis report of clinical benefits and risks, etc, And make a decision and notify the clinical trial sponsor within 60 working days from the date of accepting the application. If no notice is given within the time limit, it shall be deemed as consent. If a clinical trial is approved, it shall be notified to the drug regulatory department and the competent health department of the people's Government of the province, autonomous region or municipality directly under the central government where the clinical trial institution is located.

The catalogue of class III medical devices with high risk to human body in clinical trials shall be formulated, adjusted and published by the drug regulatory department under the State Council.

Article 28 to carry out clinical trials of medical devices, ethical review shall be carried out in accordance with the provisions, the subjects shall be informed of the purpose, purpose and possible risks of the trial, and the written informed consent of the subjects shall be obtained; If the subject is a person without or with limited civil capacity, he shall obtain the written informed consent of his guardian according to law.

When conducting clinical trials, no fees related to clinical trials shall be charged to the subjects in any form.

Article 29 those undergoing clinical trials shall be strictly controlled for treatment