Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's Republic of China)

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

No. 739

The Regulations on the Supervision and Administration of Medical Devices have been revised and passed at the 119th Executive Meeting of the State Council on December 21, 2020, and are hereby promulgated. They will come into effect on June 1, 2021 Premier Li Keqiang

February 9, 2021

 

Regulations on the Supervision and Management 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 approved at the 39th executive meeting of the State Council on February 12, 2014. Revised and approved at the 119th executive meeting of the State Council on December 21, 2020 based on the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017.)

Chapter 1 General Provisions

 

Article 1: In order to ensure the safety and effectiveness of medical devices, safeguard human health and life safety, and promote the development of the medical device industry, this regulation is formulated

Article 2: The development, production, operation, and use of medical devices within the territory of the People's Republic of China, as well as their supervision and management, shall be governed by these Regulations

Article 3: The drug regulatory department of the State Council is responsible for the supervision and management of medical devices nationwide

The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective responsibilities

Article 4: Local people's governments at or above the county level shall strengthen their leadership over the supervision and management of medical devices in their respective administrative regions, organize and coordinate the supervision and management of medical devices and emergency response work within their respective administrative regions, strengthen the construction of medical device supervision and management capabilities, and provide guarantees for the safety of medical devices

The departments responsible for drug supervision and management of local people's governments at or above the county level are responsible for the supervision and management of medical devices in their respective administrative regions. The relevant departments of local people's governments at or above the county level shall be responsible for the supervision and management of medical devices within their respective responsibilities

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

Article 6: The state implements classified management of medical devices according to their degree of risk

The first type is medical devices with a low level of risk, and implementing routine management can ensure their safety and effectiveness

The second type is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness

The third category is medical devices that have high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness

When evaluating the risk level of medical devices, factors such as the expected purpose, structural characteristics, and usage methods of the medical device should be considered

The drug regulatory department of the State Council is responsible for formulating classification rules and catalogs for medical devices, and timely analyzing and evaluating the risk changes of medical devices based on their production, operation, and use, and adjusting the classification rules and catalogs. When formulating and adjusting classification rules and catalogs, it is necessary to fully listen to the opinions of medical device registrants, recorders, production and operation enterprises, user units, and industry organizations, and refer to international medical device classification practices. The classification rules and catalog of medical devices shall be made public to the society

Article 7 Medical device products shall comply with mandatory national standards for medical devices; If there are no mandatory national standards, they should comply with the mandatory industry standards for medical devices

Article 8: The state shall formulate plans and policies for the medical device industry, incorporate medical device innovation into the development focus, prioritize the evaluation and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The drug regulatory department of the State Council shall cooperate with relevant departments of the State Council to implement the national medical device industry plan and guidance policies

Article 9: The state shall improve the innovation system of medical devices, support basic and applied research of medical devices, promote the promotion and application of new technologies in medical devices, and provide support in technology project approval, financing, credit, bidding procurement, medical insurance, and other aspects. Support enterprises to establish or jointly establish research and development institutions, encourage cooperation between enterprises and universities, research institutes, medical institutions, etc. 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 strengthens the informationization construction of medical device supervision and management, improves the level of online government services, and provides convenience for medical device administrative licensing, filing, etc

Article 11: Medical device industry organizations shall strengthen industry self-discipline, promote the construction of an integrity system, supervise enterprises to carry out production and business activities in accordance with the law, and guide enterprises to be honest and trustworthy

Article 12: Units and individuals who have made outstanding contributions in the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations Chapter 2 Registration and Filing of Medical Device Products

Article 13: The first category of medical devices shall be subject to product registration management, while the second and third categories of medical devices shall be subject to product registration management

Medical device registrants and registrants shall strengthen the quality management of the entire life cycle of medical devices, and bear responsibility for the safety and effectiveness of traditional Chinese medicine medical devices throughout the development, production, operation, and use process in accordance with the law

Article 14: For the registration of Class I medical device products and for the registration of Class II and Class III medical device products, the following documents shall be submitted:

（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 should comply with the requirements of the drug regulatory department of the State Council. It can be a self inspection report of the medical device registration applicant or the registrant, or an inspection report issued by a qualified medical device inspection institution entrusted

Those who comply with Article 24 of these Regulations and are exempt from clinical evaluation may be exempted from submitting clinical evaluation materials

Medical device registration applicants and registrants should ensure that the submitted materials are legal, true, accurate, complete, and traceable

Article 15: For the registration of Class I medical device products, the registrant shall submit the registration materials to the department responsible for drug supervision and management of the municipal people's government in the district where the registrant is located

For overseas registrants who export Class I medical devices to China, their designated domestic enterprise legal representative shall submit the registration materials and proof of approval from the competent authorities of the country (region) where the registrant is located for the marketing and sales of the medical device to the drug regulatory department of the State Council. Innovative medical devices that have not been listed overseas may not be required to submit proof documents from the competent authorities of the country (region) where the registrant is located that allow the medical device to be listed for sale

The registrant shall complete the filing upon submitting the filing materials that comply with the provisions of this Regulation to the department responsible for drug supervision and management. The department responsible for drug supervision and management shall, within 5 working days from the date of receiving the filing materials, disclose the relevant information to the society through the online government service platform of the State Council's drug supervision and management department

If there is a change in the items stated in the filing materials, the original filing department shall be notified of the change in filing

Article 16: To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the local province, autonomous region, or municipality directly under the central government. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the State Council

For overseas registration applicants who export Class II and Class III medical devices to China, their designated domestic enterprise legal representative shall submit registration application materials and proof documents from the competent authorities of the country (region) where the registration applicant is located that allow the medical device to be sold on the market to the drug regulatory department of the State Council. Innovative medical devices that have not been listed overseas may not be required to submit proof documents from the competent authorities of the country (region) where the registration applicant is located that allow the medical device to be listed for sale

The drug regulatory department of the State Council shall formulate regulations on the procedures and requirements for the registration and review of medical devices, and strengthen supervision and guidance on the registration and review work 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 registration applications shall review the safety and effectiveness of medical devices, as well as the registration applicant's ability to ensure the safety and effective quality management of medical devices

The drug regulatory department that accepts registration applications shall transfer the registration application materials to the technical evaluation institution within 3 working days from the date of acceptance of the registration application. 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 approval

If the drug regulatory department that accepts the registration application deems it necessary to verify the quality management system during the technical evaluation of medical devices, it shall organize quality management system verification

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

The drug regulatory department that accepts registration applications shall, within 5 working days from the date of approval for registration of medical devices, disclose relevant registration information to the public through the online government service platform of the State Council's drug regulatory department

Article 19: For medical devices used for the treatment of rare diseases, serious life-threatening diseases without effective treatment methods, and urgently needed in response to public health events, the drug regulatory department that accepts registration applications may make conditional approval decisions and specify relevant matters in the medical device registration certificate

In the event of a particularly significant public health emergency or other serious threat to public health, the competent health department of the State Council shall propose suggestions for the emergency use of medical devices based on the needs of prevention and control of the event. After the organization and approval of the drug regulatory department of the State Council, emergency use of medical devices can be carried out within a certain range and period

Article 20: Medical device registrants and registrants shall fulfill the following obligations:

（1） Establish a quality management system that is suitable for the product and maintain effective operation

（2） Develop a post market research and risk management plan and ensure effective implementation

（3） Conduct adverse event monitoring and re evaluation in accordance with the law

（4） Establish and implement product traceability and recall systems

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

The domestic enterprise legal person designated by the overseas medical device registrant and registrant in China shall assist the registrant and registrant in fulfilling 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 methods of use of registered Class II and Class III medical device products that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department to handle the registration change procedures; If other changes occur, they shall be filed or reported in accordance with the regulations of the drug regulatory department of the State Council

Article 22: The validity period of the medical device registration certificate is 5 years. If the registration needs to be renewed after the expiration of the validity period, an application for renewal of registration should be submitted to the original registration department 6 months before the expiration of the validity period

Except for the circumstances specified in the third paragraph 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 a decision is not made within the prescribed time limit, it shall be deemed that the extension is granted

If one of the following situations occurs, the registration shall not be renewed:

（1） Failure to submit an application for renewal of registration within the prescribed time limit

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

（3） Medical devices approved with conditions have not completed the items specified in the medical device registration certificate within the specified period

Article 23: For newly developed medical devices that have not been included in the classification catalog, the applicant may directly apply for product registration in accordance with the provisions of this Regulation on the registration of Class III medical device products, or determine the product category based on the classification rules and apply to the drug regulatory department of the State Council for category confirmation before applying for product registration or filing in accordance with the provisions of this Regulation

For those who directly apply for the registration of Class III medical device products, the drug regulatory department of the State Council shall determine the category based on the degree of risk, and promptly include the approved medical devices in the classification catalog. If the application category is confirmed, the drug regulatory department of the State Council shall, within 20 working days from the date of acceptance of the application, determine the category of the medical device and notify the applicant

Article 24: The registration and filing of medical device products shall undergo clinical evaluation; However, if one of the following conditions is met, clinical evaluation can be exempted:

（1） The working mechanism is clear, the design is standardized, the production process is mature, and the same type of medical device has been clinically applied for many years without serious adverse event records, without changing its conventional use

（2） Other non clinical evaluations can demonstrate the safety and effectiveness of the medical device

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

Article 25: Clinical evaluation of medical devices may be conducted based on product characteristics, clinical risks, existing clinical data, etc., by conducting clinical trials, or by analyzing and evaluating clinical literature and data of the same variety of medical devices, to prove the safety and effectiveness of medical devices

According to the regulations of the drug regulatory department of the State Council, when conducting clinical evaluation of medical devices, if the existing clinical literature and data are insufficient to confirm the safety and effectiveness of the product, clinical trials should be conducted

Article 26: Clinical trials of medical devices shall be conducted in accordance with the requirements of the quality management standards for clinical trials of medical devices, in clinical trial institutions with corresponding conditions, and shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality where the clinical trial applicant is located. The drug regulatory department that accepts clinical trial registration shall report the registration situation to the drug regulatory department and health regulatory department at the same level in the location of the clinical trial institution

Medical device clinical trial institutions implement record keeping management. The conditions that medical device clinical trial institutions should possess, as well as the filing management measures and clinical trial quality management standards, shall be formulated and announced by the drug regulatory department of the State Council in conjunction with the health regulatory department of the State Council

The state supports medical institutions in conducting clinical trials, including the evaluation of clinical trial conditions and capabilities in the level evaluation of medical institutions, and encourages medical institutions to carry out innovative medical device clinical trials

Article 27: Clinical trials of Class III medical devices that pose a high risk to the human body shall be approved by the drug regulatory department of the State Council. The drug regulatory department of the State Council shall conduct a comprehensive analysis of the equipment, professional personnel, and other conditions of the institution intended to undertake clinical trials of medical devices, the risk level of the medical device, the clinical trial implementation plan, and the comparative analysis report of clinical benefits and risks. The decision shall be made and the clinical trial applicant shall be notified within 60 working days from the date of acceptance of the application. If no notice is given within the time limit, it shall be deemed as consent. If clinical trials are allowed, they shall be notified to the drug regulatory department and the health regulatory 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 list of Class III medical devices with high risks to the human body in clinical trials shall be formulated, adjusted, and published by the drug regulatory department of the State Council

Article 28: When conducting clinical trials of medical devices, ethical review shall be conducted in accordance with regulations, and detailed information such as the purpose, purpose, and potential risks of the trial shall be informed to the subjects, and written informed consent shall be obtained from the subjects; If the subject is a person without or with limited civil capacity, they shall obtain written informed consent from their guardian in accordance with the law

Clinical trials shall not be conducted and fees related to clinical trials shall not be charged to subjects in any form

Article 29: Medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatment methods may benefit patients through medical observation. After ethical review and informed consent, they can be used free of charge for other patients with similar conditions in institutions conducting clinical trials of medical devices. Their safety data can be used for medical device registration applications

Chapter 3 Medical Device Production

Article 30: To engage in the production of medical devices, the following conditions shall be met:

（1） Having a production site, environmental conditions, production equipment, and professional technical personnel suitable for the production of medical devices

（2） Having institutions or dedicated inspectors and inspection equipment capable of conducting quality inspections on medical devices produced

（3） There is a management system to ensure the quality of medical devices

（4） Having the ability to provide after-sales service that is suitable for the medical devices produced

（5） Meet the requirements specified in product development and production process documents

Article 31 Those engaged in the production of Class I medical devices shall file with the department in charge of drug supervision and administration under the people's government of the city divided into districts where they are located, and the filing shall be completed after the submission of relevant materials meeting the requirements specified in Article 30 of these Regulations

If the medical device registrant produces the first type of medical device on their own, they may submit relevant materials that meet the conditions specified in Article 30 of this Regulation when filing the product in accordance with Article 15 of this Regulation, and complete the production filing

Article 32: Those engaged in the production of Class II and Class III medical devices shall apply for a production license from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and submit relevant materials that meet the conditions stipulated in Article 30 of these Regulations, as well as the registration certificate of the medical devices produced

The drug regulatory department that accepts production license applications shall review the application materials, verify them in accordance with the requirements of the quality management standards for medical device production formulated by the drug regulatory department of the State Council, and make a decision within 20 working days from the date of acceptance of the application. For those who meet the prescribed conditions, a license shall be granted and a medical device production license shall be issued; For those who do not meet the prescribed conditions, no permission shall be granted and written reasons shall be provided

The validity period of the medical device production license is 5 years. If the validity period needs to be extended upon expiration, the extension procedures shall be handled in accordance with the relevant laws and regulations on administrative licensing

Article 33: The quality management standards for medical device production shall clearly stipulate the design and development of medical devices, production equipment conditions, raw material procurement, production process control, product release, organizational structure and personnel allocation of enterprises, and other matters that affect the safety and effectiveness of medical devices

Article 34: Medical device registrants and registrants may produce medical devices themselves, or entrust enterprises that meet the provisions of these regulations and meet corresponding conditions to produce medical devices

If a medical device is commissioned for production, the medical device registrant and registrant shall be responsible for the quality of the medical device commissioned for production, and strengthen the management of the production behavior of the commissioned production enterprise to ensure that it produces in accordance with legal requirements. The medical device registrant and registrant shall sign a commission agreement with the entrusted production enterprise, clarifying the rights, obligations, and responsibilities of both parties. The entrusted production enterprise shall organize production in accordance with laws and regulations, medical device production quality management standards, mandatory standards, product technical requirements, and commission agreements, be responsible for production behavior, and accept supervision from the commissioning party

Implantable medical devices with high risks shall not be commissioned for production, and the specific catalog shall be formulated, adjusted, and published by the drug regulatory department of the State Council

Article 35: Medical device registrants, recorders, and entrusted production enterprises shall establish and improve a quality management system suitable for the medical devices they produce in accordance with the quality management standards for medical device production, and ensure their effective operation; Strictly organize production in accordance with the registered or registered product technical requirements, ensuring that the medical devices manufactured meet mandatory standards and the registered or registered product technical requirements

Medical device registrants, recorders, and entrusted production enterprises shall regularly conduct self inspections of the operation of the quality management system and submit self inspection reports in accordance with the regulations of the drug regulatory department of the State Council

Article 36: If the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, the medical device registrant, registrant, and entrusted production enterprise shall immediately take corrective measures; If it may affect the safety and effectiveness of medical devices, production activities should be immediately stopped and reported to the original production license or production filing department

Article 37 Medical devices shall use a common name. The universal name shall comply with the naming rules for medical devices formulated by the drug regulatory department of the State Council

Article 38: The state shall implement a unique identification system for medical devices step by step based on the category of medical device products, to achieve traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council

Article 39 Medical devices shall have instructions and labels. The content of the instruction manual and label should be consistent with the relevant content registered or filed, ensuring authenticity and accuracy

The instructions and labels of medical devices should indicate the following:

（1） Common name, model, and specification

（2） The names, addresses, and contact information of the medical device registrant, registrant, and entrusted production enterprise

（3） Production date, service life or expiration date

（4） Product performance, main structure, and scope of application

（5） Taboos, precautions, and other contents that require warning or reminder

（6） Installation and usage instructions or illustrations

（7） Maintenance and upkeep methods, special transportation and storage conditions and methods

（8） Other contents that should be indicated in the product technical requirements

The second and third categories of medical devices should also indicate the medical device registration certificate number

Medical devices used by consumers themselves should also have special instructions for safe use

Chapter 4: Medical Device Management and Use

Article 40: To engage in the business activities of medical devices, there shall be a business premises and storage conditions that are suitable for the scale and scope of business, as well as a quality management system and quality management institutions or personnel that are suitable for the medical devices being operated

Article 41: For those engaged in the operation of Class II medical devices, the operating enterprise shall file a record with the department responsible for drug supervision and management of the municipal people's government with districts in its location and submit relevant materials that meet the conditions specified in Article 40 of these Regulations

According to the