NMPA

In September 2020, the Announcement of the State Food and Drug Administration on Matters related to the production of Imported Medical Device Products in Chinese domestic enterprises (No. 104 of 2020, hereinafter referred to as the Announcement) was issued and implemented. In order to fully implement the deployment of the Party Central Committee and The State Council on promoting high-level opening to the outside world, fully implement the requirements of The General Office of the State Council on Comprehensively Deepening the Reform of Pharmaceutical and Medical Device Supervision and Promoting the high-quality development of the Pharmaceutical Industry (GuOCofa (2024) No. 53), continue to deepen the reform of medical device supervision and promote the high-quality development of the medical device industry, The requirements for further adjustment and optimization of the "Announcement" are as follows:

一、Scope of application

The foreign-invested enterprise mentioned in the Announcement may be an enterprise established by the registrant of imported medical devices, or an enterprise with the same actual controller as the registrant of imported medical devices. That is, the Announcement applies to matters related to the establishment of imported medical device registrants, or foreign-invested enterprises with the same actual controller, in the territory of the People's Republic of China to produce Class II and Class III products that have obtained imported medical device registration certificates.

The actual controller shall conform to the relevant definitions and provisions of the Company Law of the People's Republic of China, that is, the actual controller refers to the person who can actually control the conduct of the company through investment relations, agreements or other arrangements.

二、Registration and declaration requirements

（一）The registration applicant shall comply with the requirements of the "Announcement of the State Drug Administration on the publication of medical device registration application data requirements and approval certification document Format" (No. 121 of 2021) and the "Announcement of the State Drug Administration on the publication of in vitro diagnostic reagent registration application data requirements and approval certification document format" (No. 122 of 2021) Form, catalog, etc. Submit registration declaration materials.

Among them, the summary data of the product, non-clinical data (except the list of basic principles of ** and performance, product technical requirements and inspection reports), clinical evaluation data, can use the original registration and declaration data of imported medical devices. Product technical requirements and inspection reports shall reflect that the product meets the applicable mandatory standards.

（二）If the registration applicant and the imported medical device registrant have the same actual controller, the explanation and supporting documents that the two parties have the same actual controller shall be provided. Supporting documents shall include the registration applicant's Annual Report of the Enterprise and other reports containing the actual controller information that are close to the registration application date and have been uploaded or disclosed according to the requirements of the competent authorities. The corresponding instructions and supporting documents shall be filed by the drug regulatory department for future reference.

（三）The registration applicant shall submit a letter of authorization issued by the registrant of imported medical devices that explicitly agrees that the registration applicant shall use the original registration declaration data of imported medical devices to carry out domestic registration declaration and produce products. The letter of authorization shall be notarized by the notary institution where the registrant of the imported medical device is located.

三、registration system verification requirements

The registration applicant shall promise that the main raw materials and the main production process will not change, and provide a self-inspection report of the product production quality management system in line with China's "Medical Device production quality Management Standards" and a comparison report of domestic and foreign quality management systems.

Drug regulatory departments in accordance with the medical device registration quality management system verification procedures, to carry out verification of domestic registration applicants, while focusing on the product design and development links of domestic and foreign quality management system substantive equality.

For domestic products to be registered and imported medical device product quality management system differences, the registration applicant should explain in detail, promise that the relevant differences will not cause changes in registration matters, while doing a good risk analysis, clear the main risk points and control measures, to ensure that the product is perfect, effective, quality control.

四、Other aspects

（一）For imported innovative medical device products produced in China in accordance with the requirements of the Announcement, the corresponding registration, production license and other matters shall be handled first.

（二）Where an overseas registrant invested by a Chinese domestic enterprise produces Class II and Class III medical device products in China that have obtained the registration certificate for imported medical devices, the Chinese domestic enterprise investing in the overseas registrant or other domestic enterprises with the same actual controller as the domestic enterprise shall apply for the registration of the product and produce it on its own as the registration applicant.

（三）The subsequent change of registration and extension of registration of products approved for registration shall be handled in accordance with the provisions of the Measures for the Management of Medical Device Registration and Filing and the Measures for the Management of in Vitro Diagnostic Reagent Registration and Filing.

It is hereby announced.