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Chapter I General Provisions
Article 1 These Regulations are formulated for the purpose of ensuring the safety and effectiveness of medical devices, safeguarding human health and life safety, and promoting the development of the medical device industry.
Article 2 These Regulations shall apply to the research and development, production, management and use of medical devices within the territory of the People's Republic of China as well as their supervision and administration.
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 of the State Council shall be responsible for the supervision and administration of medical devices within the scope of their respective functions and duties.
Article 4 The local people's government at or above the county level shall strengthen the leadership of the supervision and administration of medical devices within its administrative region, organize and coordinate the supervision and administration of medical devices within its administrative region as well as the emergency response work, strengthen the capacity building of the supervision and administration of medical devices, and provide guarantee for the safety work of medical devices.
The departments responsible for drug supervision and administration under the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative regions. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective functions and duties.
Article 5 The supervision and administration of medical devices shall follow the principles of risk management, whole-process control, scientific supervision and social co-governance.
Article 6 The State shall carry out classified management of medical devices according to the degree of risk.
The first category is low risk degree, the implementation of routine management can ensure its safety and effectiveness of medical devices.
The second category is the medical devices with moderate risks, which need to be strictly controlled and managed to ensure their safety and effectiveness.
The third category is the medical devices with high risks, which need to take special measures to strictly control and manage to ensure their safety and effectiveness.
In evaluating the risk degree of medical devices, factors such as the intended purpose, structural characteristics and application methods of medical devices should be considered.
The drug regulatory department under the State Council shall be responsible for formulating the classification rules and catalogue of medical devices, and shall timely analyze and evaluate the risk changes of medical devices and make adjustments to the classification rules and catalogue based on the production, marketing and use of medical devices. When formulating and adjusting the classification rules and catalogue, the opinions of medical device registrants, record holders, production and business enterprises, user units and industrial organizations shall be fully solicit, and the international medical device classification practice 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 compulsory national standard, the medical device industry standard shall be complied with.
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 the 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 applied research of medical devices, promote the popularization and application of new technologies of medical devices, and provide support in scientific and technological project approval, financing, credit, bidding and procurement, medical insurance and other aspects. Support enterprises to set up or jointly set up research and development institutions, encourage enterprises to cooperate with institutions of higher learning, scientific research institutes and medical institutions to carry out research and innovation of medical devices, strengthen protection of intellectual property rights of medical devices, and improve the ability of independent innovation of medical devices.
Article 10 The State shall strengthen the construction of informatization in the supervision and management of medical devices, improve the level of online government services, and provide convenience for the administrative licensing and filing of medical devices.
Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of credit system, urge enterprises to carry out production and operation 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 Device Products
Article 13 Category I medical devices shall be subject to the management of product registration, while category II and category III medical devices shall be subject to the management of product registration.
Registrants and recorders of medical devices shall strengthen the quality management of the whole life cycle of medical devices, and shall be legally responsible for the safety and effectiveness of medical devices during the whole process of research, production, operation and use.
Article 14 The following materials shall be submitted for the record of Class I medical device products and for the registration of Class II and Class III medical device products:
(1) Product risk analysis data;
(2) Technical requirements of the product;
(3) Product inspection report;
(4) Clinical evaluation data;
(5) Product specifications and sample labels;
(6) Documents of quality management system related to product development and production;
Other materials needed to prove the safety and effectiveness of the products.
The product inspection report shall meet the requirements of the drug regulatory department under the State Council, and may be the self-inspection report of the medical device registration applicant and the record holder, or the inspection report entrusted to a qualified medical device inspection institution to be issued.
Those who meet the circumstances of exemption from clinical evaluation prescribed in Article 24 of these Regulations may be exempted from submitting clinical evaluation data.
The medical device registration applicant and the record holder shall ensure that the materials submitted are legal, true, accurate, complete and traceable.
Article 15 For recordkeeping of Category I medical devices, the recorder shall submit the recordkeeping materials to the department in charge of drug supervision and administration of the people's government of the city divided into districts where it is located.
For an overseas record holder exporting Category I medical devices within the territory of China, the domestic enterprise legal person designated by the foreign record holder shall submit the record filing materials and the certification documents of the competent authority of the country (region) of the record holder's home country approving the marketing of such medical devices to the drug regulatory department under the State Council. For an innovative medical device that has not been listed abroad, the competent authority of the country (region) where the archivist resides may not submit the certificate approving the marketing of such medical device.
The archival filing shall be completed upon submission of archival filing materials conforming to the provisions of these Regulations to the department responsible for drug supervision and administration. The department in charge of drug supervision and administration shall, within 5 working days from the date of receiving the archival data, publicize relevant archival information to the public through the online government affairs service platform of the drug regulatory department under the State Council.
Where any item specified in the archival documents changes, it shall be changed to the original archival department for archival purposes.
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 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 device products, the registration applicant shall submit the registration application materials to the drug regulatory department under the State Council.
Where an overseas registration applicant exports Category II or III medical devices within the territory of China, the domestic enterprise legal person designated by the applicant shall submit to the drug regulatory department under the State Council the registration application materials and the certification documents of the competent authority of the country (region) where the registration applicant is located approving the marketing of the medical devices. An innovative medical device that has not been listed abroad may not submit the certificate approving the marketing of such medical device by the competent authority of the country (region) where the registration applicant is located.
The drug regulatory department under the State Council shall stipulate the procedures and requirements for the registration examination of medical devices, and strengthen supervision and guidance over 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 accepting the application for registration shall examine the safety and effectiveness of the medical devices and the ability of the registration applicant to guarantee the safety and effective quality management of the medical devices.
The drug regulatory department accepting the application for registration shall, within 3 working days from the date of accepting the application for registration, hand over the materials of the application for registration to the technical evaluation institution. The technical evaluation agency shall, after completing the technical evaluation, submit the evaluation opinions to the drug regulatory department accepting the application for registration as the basis for approval.
Where the drug regulatory department accepting the application for registration deems it necessary to inspect the quality management system when organizing the technical evaluation of medical devices, it shall organize and carry out the inspection of the quality management system.
Article 18 The drug regulatory department that accepts the application for registration shall make a decision within 20 working days from the date of receiving the evaluation opinions. To those who meet the requirements, registration shall be granted and a medical device registration certificate shall be issued; Those who do not meet the requirements shall not be registered and shall give reasons in writing.
The drug regulatory department accepting the application for registration shall, within 5 working days from the date of approving the registration of medical devices, publish the registration information to the society through the online government affairs service platform of the drug regulatory department under the State Council.
Article 19 The drug regulatory department accepting the application for registration may make conditional approval decisions for urgently needed medical devices used for the treatment of rare diseases, diseases seriously endangering life and diseases with no effective treatment means, and for responding to public health events, and shall specify relevant matters in the registration certificate of medical devices.
Appear particularly important public health emergencies or other serious threat to public health emergencies, health administrative department under the State Council according to the need of the prevention and control of events suggest use of emergency medical apparatus and instruments, after agreed by the pharmaceutical supervisory and administrative department under the State Council organization argument can be used in a certain range within the time limit and emergency.
Article 20 The registrant and record holder of a medical device shall perform the following obligations:
(1) Establish a quality management system suitable for the products and maintain its effective operation;
(II) Formulate post-listing research and risk control plans and ensure their effective implementation;
(3) To carry out monitoring and reevaluation of adverse events according to law;
(4) Establish and implement product traceability and recall systems;
(5) Other obligations stipulated by the pharmaceutical supervisory and administrative department under the State Council.
The domestic enterprise legal person designated by the overseas medical device registrant or record holder shall assist the registrant or record holder to fulfill the obligations prescribed in the preceding paragraph.
Article 21 Where there are substantial changes in the design, raw materials, production process, scope of application and method of use of Class II and Class III medical devices that have been registered, which may affect the safety and effectiveness of the medical devices, the registrant shall apply to the original registration department for the registration alteration procedures; Any other changes shall be put on record or reported in accordance with the provisions of the drug regulatory department under the State Council.
Article 22 The term of validity of the medical device registration certificate is 5 years. Where it is necessary to renew the registration upon expiration of the term of validity, an application for renewal of registration shall be filed with the original registration department 6 months prior to the expiration of the term of validity.
Except for the circumstances as provided for in paragraph 3 of this Article, the drug regulatory department that has received the application for renewal of registration shall make a decision to grant renewal before the expiration of the validity period of the medical device registration certificate. If no decision is made within the time limit, the extension shall be deemed to be granted.
Registration shall not be renewed under any of the following circumstances:
(1) Failure to apply for renewal of registration within the prescribed time limit;
(2) The compulsory standards for medical devices have been revised, and the medical devices applying for renewed registration cannot meet the new requirements;
(3) For medical devices with conditional approval, it fails to complete the items specified in the registration certificate of medical devices within the prescribed time limit.
Article 23 of the newly developed has not been listed in the catalog of medical apparatus and instruments, the applicant may, in accordance with the regulations related to the regulation of the third class medical equipment product registration directly apply for product registration, can also according to the classification rules determine the product category and applied to the pharmaceutical supervisory and administrative department under the State Council for type confirmed in accordance with the provisions of these regulations apply to product registration or for a product for the record.
If a medical device product of Category III is directly applied for registration, the drug regulatory department under the State Council shall determine the category according to the degree of risk, and timely include the medical device approved for registration into the classified catalogue. If the category of the application is confirmed, the drug regulatory department under the State Council shall, within 20 working days from the date of accepting the application, determine the category of the medical device and inform the applicant.
Article 24 Clinical evaluation shall be conducted in the registration and filing of medical device products; However, if one of the following conditions is met, clinical evaluation may be exempted:
(1) A medical device of the same type that has been marketed with clear working mechanism, finalized design, mature production technology, and has been clinically used for many years without records of serious adverse events, and does not change its routine use;
(2) Other medical devices that can be proved to be safe and effective through non-clinical evaluation.
The drug regulatory department under the State Council shall formulate guidelines for clinical evaluation of medical devices.
Article 25 Clinical evaluation of medical devices may be conducted to prove the safety and effectiveness of medical devices 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 and existing clinical data.
According to the provisions of the drug regulatory department under the State Council, when conducting 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 A clinical trial of medical devices shall be conducted in a clinical test institution with appropriate conditions in accordance with the requirements of the quality control standards for clinical trial 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 sponsor of the clinical trial is located. The drug regulatory department that accepts the filing of clinical trial shall notify the drug regulatory department and the competent health department at the same level where the clinical trial institution is located.
Institutions for clinical trial of medical devices shall implement archival management. The requirements that a medical device clinical test institution shall have, the measures for archival administration and the standards for the quality control of clinical trials shall be formulated and promulgated by the drug regulatory department under the State Council jointly with the competent health department under the State Council.
The state supports medical institutions in carrying out clinical trials, includes evaluation of clinical trial conditions and capabilities in the hierarchical evaluation of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.
Article 27 Where a clinical trial of Category III medical devices has a high risk to human beings, it shall be approved by the pharmaceutical supervisory and administrative department under the State Council. The pharmaceutical supervisory and administrative department under the State Council for examination and approval of clinical trials of medical devices shall be assumed to clinical trials of equipment, professional conditions, the degree of risk for medical devices and clinical trial implementation plan, clinical benefit and risk analysis report and other comprehensive analysis, and 60 working days from the date of acceptance of application, make a decision and notify the sponsor clinical trials. Failure to notify within the time limit shall be deemed as consent. Where a clinical trial is approved, a notification shall be made 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 the third category of medical devices with high risk to human beings from clinical trials shall be formulated, adjusted and promulgated by the drug regulatory department under the State Council.
Article 28 When conducting a clinical trial of a medical device, ethical review shall be conducted in accordance with the provisions, and detailed information such as the purpose, use and possible risks of the test shall be informed to the subjects, and written informed consent shall be obtained from the subjects; If the subject is a person without civil capacity or a person with limited civil capacity, he/she shall obtain the written informed consent of his/her guardian according to law.
In conducting a clinical trial, no fees related to the clinical trial shall be charged from the subjects in any form.
Article 29 for ongoing clinical trials for the treatment of severe life-threatening and there is no effective treatment of diseases of medical apparatus and instruments, the medical observation may bring benefit to patients, after ethical review, informed consent, can the institutions of medical instrument clinical trial in free for other patients with the same illness, its safety data can be used for medical device registration.
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