In September 2020, the NMPA Announcement on Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 104, 2020, hereinafter referred to as the Announcement) was issued and implemented. To thoroughly implement the decisions of the CPC Central Committee and the State Council on advancing high-level opening-up, fully carry out the requirements of 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), continuously deepen the reform of medical device regulation, and promote the high-quality development of the medical device industry, the following adjustments and optimizations are hereby made to certain provisions of the Announcement:

I. Scope of Application

The foreign-invested enterprises referred to in the Announcement can either be an enterprise established by the imported medical device registrant or an enterprise that shares the same actual controller as the registrant of the imported medical device. In other words, this Announcement is applicable to matters concerning the production of Class II and Class III medical devices with imported medical device registration certificates in the People's Republic of China by the imported medical device registrants through their foreign-invested enterprises established in China or the foreign-invested enterprises that share the same actual controller as the registrants of the imported medical device.

The actual controller shall comply with the relevant definitions and provisions of the Company Law of the People's Republic of China, which stipulates that an actual controller refers to a person who can actually control the company’s actions through investment relationships, agreements, or other arrangements.

II. Requirements for Registration and Application

(1) 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.

(2) 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. 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 been 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.

(3) 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.

III. Registration System Verification Requirements

The registration applicant shall commit that there will be no changes in the main raw materials and main production processes and provide a self-inspection report that the domestic production quality management system of the product complies with the Good Manufacturing Practice for Medical Devices and a comparison report of overseas and domestic quality management systems.

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 changes 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.

IV. Other Aspects

(1) For imported innovative medical devices produced within China in accordance with the requirements of the Announcement, the relevant registration, production licensing, and other matters shall be given priority in processing.

(2) For the production of Class II and Class III medical devices with imported medical device registration certificates in China by overseas registrants invested by Chinese domestic enterprises, the domestic investor enterprise or another domestic enterprise that shares the same actual controller may serve as the registration applicant to apply for product registration and undertake production.

(3) For products already approved for registration, subsequent matters such as registration changes and renewals shall be handled in accordance with the Provisions for Medical Device Registration and Filing and the Provisions for In-vitro Diagnostic Reagent Registration and Filing.

It is hereby announced.

National Medical Products Administration

March 17, 2025