Announcement of the National Medical Products Administrationon Matters Concerning Further Adjusting and Optimizing theProduction of Imported Medical Devices by Enterprises in China (N0.30, 2025)

Announcement of the National Medical Products Administrationon Matters Concerning Further Adjusting and Optimizing theProduction of Imported Medical Devices by Enterprises in China(N0.30, 2025)

In September 2020, the Announcement of the National Medical Products Administration on MattersConcerning the Production of Imported Medical Devices by Enterprises in China (No.104, 2020hereinafter referred to as the Announcement) was issued and implemented. To thoroughly carry out thedeployment made by the Central Committee of the Communist Party of China and the State Council toadvance high-level opening to the outside world, fully implemnt the requirements of the Opinions oftheGeneral Ofice ofthe State Council on Comprehensively Deepening the Regulatory Reform ofDrugs andMedical Devices to Promote the High-guality Development ofthe Pharmaceutical industry (GBF [2024No.53), continuously deepen the regulatory refonm of medical devices, and promote the high-qualitydevelopment of the medical device industry, some requirements of the Announcement are further adjustedand optimized as follows:

I. Scope ofApplication

The foreign-invested enterprises mentioned in the Anmouncement may be an enterprise established bythe registrant of imported medical devices, or an enterprise with the same actual controller as the registrantof imported medical devices. That is, the Announcement applies to matters related to the production ofClass ll and Class lll products that have obta

ined registration certificates for imported medical deviceswithin the territory of the People's Republic of China by foreign-invested enterprises established byregistrants of imported medical devices or with the same actual controller.

The actual controller shall comply with the relevant definitions and provisions stipulated in theCompany Law ofthe People's Republic of'China, that is, the actual controller refers to the person who canpractically dominate the behaviors of a company through an investment relationship, agreement, or otherarrangements.

II. Requirements for Registration Application

(l)The registration applicant shall submit the registration application dossiers in accordanee with theformats and contents required in the Announcement of National Medical Products Administration onIssuing the Requirements for the Registration Application Dossiers and the Format ofApproval Certificatesof Medical Devices (No.121, 2021)and Announcement of National Medical Products Administration onIssuing the Requirements for Registration Application Dossiers ofIn Vitro Diagnostic Reagents andFormats efApproval Documents (No.122, 2021).

Among them, the overview data, non-clinical data (except the list of basic principles of safety andperfommance, produet technical requirements and inspection reports), and clinical evaluation data of theproduct can be the original registration application dossiers of imported medical devices. Product technicarequirements and inspection reports shall reflect that the product meets the applicable mandatory standard requriments.

(ll) If the registration applicant and the registrant of imported medical devices have the same actualcontroller, the explanatory and supporting documents that both parties have the same actual controller shalbe provided. The explanatory documents may contain the explanation of the equity relationship betweenthe two parties, etc., and the supporting documents shall include the reports containing information on theactual controller, such as the registration applicant's Anual Report of the Enterprise which is the mostrecent from the date of application for registration and have been uploaded or disclosed in accordance withthe requirements of the competent authorities. The corresponding explanatory and supporting documents.

shall be archived by the drug regulatory authority for future reference.(ll) The registration applicant shall submit a Letter of Authorizafion issued by the registrant ofimported medical devices to explicitly indicate the agreement on the use of the original registrationapplication dossiers of the imported medical devices by the registration applicant for domestic registrationapplication and production. The Letter of Authorization shall be notarized by the Notary Office where theregistrant ofthe imported medical devices is located.

III. Registration System Verification Requirements

The registration applicant shall promise that the main raw materials and the main production processwill not change, provide the self inspection report that the domestic production quality management systemof the product complies with the Good Manufacturing Practice for Medical Devices and comparison reportof overseas and domestic quality management systems.

In accordance with the medical device registration quality management system verification proceduresthe drug regulatory authorities shall conduct verilication of domestic registration applicants, and at thesame time focus on the substantive equivalence of domestic and foreign quality management systems inproduct design and development.

If there is a difference between the domestic produets to be applied for registration and the qualitymanagement system of the imported medical devices, the registration applicant shall explain in detail.promise that the relevant difierences will not cause changes in the registration items, and at the same time.make risk analysis, clarify the main risk points and control measures, and ensure the safety, efectivenessand controllable quality of the products.