In September 2020, the National Medical Products Administration (NMPA) issued and implemented the “Announcement on Matters Concerning the Production of Imported Medical Device Products by Domestic Enterprises in China” (No. 104 of 2020, hereinafter referred to as the “Announcement”).
Background and Policy Intent
To thoroughly implement the directives of the CPC Central Committee and the State Council on promoting high-level opening-up, fully carry out the requirements of the “Opinions of the General Office of the State Council on Deepening the Reform of Drug and Medical Device Regulation and Promoting the High-Quality Development of the Pharmaceutical Industry” (Document No. 53 [2024] of the General Office of the State Council), further deepen the reform of medical device regulation, and promote the high-quality development of the medical device industry, certain provisions of the Announcement are hereby adjusted and optimized as follows:
I. Scope of Application
The foreign-invested enterprises referred to in the Announcement may either be enterprises established by the registrant of the imported medical device, or enterprises under the same ultimate controller as the registrant of the imported medical device.
In other words, the Announcement applies to matters concerning the self-manufacturing within the territory of the People's Republic of China by foreign-invested enterprises—either established by, or sharing the same ultimate controller with—the registrant of imported medical devices for Class II and Class III products that have already obtained an imported medical device registration certificate.
The ultimate controller shall conform to the relevant definitions and provisions of the Company Law of the People's Republic of China, namely, the ultimate controller refers to a person who is able to actually control the conduct of a company through investment relationships, agreements, or other arrangements.
II. Registration Application Requirements
- The registration applicant shall submit the registration application materials in accordance with the format, catalog, and other requirements specified in the “Announcement of the National Medical Products Administration on Publishing the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents” (No. 121 of 2021), and the “Announcement of the National Medical Products Administration on Publishing the Requirements for In Vitro Diagnostic Reagents Registration Application Materials and the Format of Approval Documents” (No. 122 of 2021).
Among these, the summary materials of the product, non-clinical materials (excluding the list of essential principles of safety and performance, product technical requirements, and test reports), and clinical evaluation materials may utilize the original registration application materials of the imported medical device. The product technical requirements and test reports shall demonstrate that the product complies with applicable mandatory standards.
- If the registration applicant and the imported medical device registrant share the same ultimate controller, an explanation of the shared control and supporting documentation shall be provided.
The explanatory documents may include a statement on the shareholding relationship between both parties, while the supporting documents shall include the most recent “Annual Report of the Enterprise” of the registration applicant prior to the registration application date, or other reports containing information on the ultimate controller that have been uploaded or disclosed in accordance with the requirements of the competent authority. Such explanatory and supporting materials shall be archived by the drug regulatory authority for future reference.
- The registration applicant shall submit a power of attorney issued by the registrant of the imported medical device explicitly consenting to the applicant's use of the original registration application materials for domestic registration application and product manufacturing.
The power of attorney must be notarized by a notary public in the jurisdiction where the registrant of the imported medical device is located.
III. Requirements for Verification of the Registration Quality Management System
The registration applicant shall undertake that the main raw materials and primary manufacturing processes remain unchanged and shall submit a self-inspection report demonstrating that the domestic manufacturing quality management system complies with China's “Good Manufacturing Practice for Medical Devices,” along with a comparative report of the quality management systems used domestically and abroad.
In accordance with the procedures for verifying the quality management system for medical device registration, the drug regulatory authority shall conduct inspections of the domestic registration applicant, with particular emphasis on the essential equivalence between the domestic and overseas quality management systems in the product design and development stages.
Where differences exist between the quality management systems of the domestically proposed registered product and that of the imported medical device, the registration applicant shall provide a detailed explanation, undertake that such differences will not lead to changes in the registration particulars, and perform a thorough risk analysis. The applicant shall clearly identify key risk points and corresponding control measures to ensure the product's safety, efficacy, and controllable quality.
IV. Other Provisions
- For imported innovative medical device products manufactured within China in accordance with the requirements of the Announcement, the relevant matters such as registration and production licensing shall be given priority handling.
- Where an overseas registrant, invested in by a domestic enterprise in China, manufactures within China Class II or Class III medical device products that have already obtained imported medical device registration certificates, the domestic enterprise that invested in the overseas registrant, or another domestic enterprise under the same ultimate controller, shall serve as the registration applicant to apply for product registration and undertake self-manufacturing.
- Subsequent matters such as change registration and renewal registration for approved products shall be handled in accordance with the provisions of the “Measures for the Administration of Medical Device Registration and Filing” and the “Measures for the Administration of In Vitro Diagnostic Reagent Registration and Filing.”
This is hereby announced.