The NMPA Announcement on Further Adjustment and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025) was issued on March 18, 2025. This Announcement shall come into force as of the date of issuance (hereinafter referred to as the Announcement). The background, main principles, and key issues of the adjustments and optimizations in this Announcement are explained as follows:

I. Background

In 2020, the National Medical Products Administration (NMPA) issued the Announcement on Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 104, 2020) (hereinafter referred to as Announcement No. 104), which optimized the requirements for registration application dossiers, accelerated the marketing process of corresponding products, and further enriched the supply of domestic medical devices. On December 30, 2024, the Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53) was issued, which explicitly called for "optimizing the review and approval process for the transfer of already-marketed overseas drugs and medical devices to domestic production, and for supporting foreign-invested enterprises in localizing the production of original drugs and high-end medical equipment". To implement these relevant requirements, the NMPA drafted this Announcement based on in-depth research and by widely soliciting opinions from all parties.

II. Main Principles

Taking into account industry feedback on the need to further optimize relevant measures during the implementation of Announcement No. 104, this Announcement adopts a problem-oriented approach. It combines the current regulatory requirements for medical device registration management, and based on the principle of scientific regulation, further makes adjustment to the scope of application, adjusts and optimizes the registration application requirements, optimizes the requirements for registration system verification, and increases support for the domestic production of innovative products on the basis of Announcement No. 104. The contents of Announcement No. 104 not addressed in this Announcement shall remain valid.

III. Explanation of Key Issues

(1) Adjustment of the scope of application. The definition of "foreign-invested enterprise" in Announcement No. 104, which was originally an enterprise established by the registrant of the imported medical device, is adjusted to "It can be an enterprise established by the registrant of the imported medical device, or an enterprise that shares the same actual controller as the registrant of the imported medical device." At the same time, it is clarified that the actual controller shall comply with the relevant definitions and regulations in the Company Law of the People's Republic of China. An actual controller refers to a person who can actually control the company’s actions through investment relationships, agreements, or other arrangements.

(2) Adjustment and optimization of registration application dossier requirements.

First, the registration applicant shall submit the application dossiers in accordance with the formats, contents, etc., required by the current application dossier requirements. That is, the registration applicant shall submit the application dossiers in accordance with the formats, contents, etc. specified in the NMPA Announcement on the Issuance of the Requirements for Registration Application Dossiers of Medical Device and the Format of Approval Documents (No. 121, 2021) and the NMPA Announcement on the Issuance of the Requirements for Registration Application Dossiers of In Vitro Diagnostic Reagents and the Format of Approval Documents (No. 122, 2021).

For the summary data, non-clinical data (except for the list of basic principles of safety and performance, product technical requirements, and test reports), and clinical evaluation data of the product, the original registration application dossiers for the imported medical devices can be submitted. However, the product technical requirements and test reports shall reflect that the product complies with the applicable mandatory standard requirements.

Second, where the registration applicant and the imported medical device registrant share the same actual controller, a statement and supporting documents proving such a relationship shall be provided by the registration applicant. The statement document may include a description of the equity relationship between the two parties. The supporting documents shall include the most recent Enterprise Annual Report of the registration applicant closest to the registration application date and other reports containing information about the actual controller, as uploaded or disclosed per requirements by the competent department. These corresponding statements and supporting documents shall be archived and retained by the medical product regulatory authority for future reference.

Third, the registration applicant shall submit a letter of authorization issued by the registrants of the imported medical devices, explicitly consenting to the registration applicant's use of the original registration application dossiers of the imported medical device for domestic registration application and product production purposes. The letter of authorization shall be notarized by a notary institution located in the place where the registrant of the imported medical device is located.

(3) Optimization of registration system verification requirements. According to the working procedure for the verification of quality management system for medical device registration, drug regulatory authorities shall conduct verifications for domestic registration applicants, focusing on the substantial equivalence of the domestic and overseas quality management systems in the product design and development process.

Where differences exist between the quality management systems of the proposed domestically registered products and imported medical devices, the registration applicant shall provide a detailed explanation, commit that such differences will not result in any change to the registered items, conduct a risk analysis to identify major risk points and corresponding control measures and ensure the safety, effectiveness, and controllable quality of the product.

(4) Support for the transfer of production of innovative products. The Announcement specifies that priority will be given to the registration and production licensing procedures for innovative imported medical devices being transferred to domestic production.

Additionally, for products approved for registration in accordance with this Announcement, subsequent change registrations and renewals shall be handled in accordance with relevant laws and regulations and will not be bound to the handling of corresponding matters for already registered imported products.