In order to further implement the Opinions on the Reform of Review and Approval System for Drugs and Medical Devices issued by the State Council and the Opinions on Deepening the Reform of Review and Approval System to Encourage Innovation of Drugs and Medical Devices issued by the General Office of the CPC Central Committee and the General Office of the State Council as well as the reform of "Streamline Administration, Delegate Power, Strengthen Regulation and Improve Services", and optimize business environment requirements, comprehensively deepen reform of the review and approval system for medical devices, promote highquality development of the medical device industry, and better meet public health needs, on September 18, 2020, NMPA announced the following matters concerning the production of products with imported medical device registration certificates in domestic enterprises in China:

I. Scope of application 

This Announcement is applicable to the matters concerning the production of Class II and Class III medical devices with imported medical device registration certificates in China by the imported medical device registrants through their foreigninvested enterprises established in China.

II.Registration requirements

(I) The foreign-invested enterprise established by an imported medical device registrant in China shall, as the registration applicant, submit the application for medical device registration in China to the corresponding drug regulatory authority. The content of the registration application, except the name, domicile and production address of the registrant, shall, in principle, be consistent with relevant items specified in the corresponding imported medical device registration certificate and its attachments.

(II) The registration applicant shall submit the registration application dossiers according to the requirements of Announcement on the Requirements for Registration Application Dossiers of Medical Devices and the Format of Approval Documents (CFDA Announcement [2014] No.43) and Announcement on the Requirements for Registration Application Dossiers of In Vitro Diagnostic Reagents and the Format of Approval Documents (CFDA Announcement [2014] No.44). For the summary data, study data, clinical evaluation data, product risk analysis data of medical devices, and the summary data, study data of main raw materials (if applicable), study data of main production process and reaction system (if applicable), analysis performance evaluation data, positive cut-off value or reference interval determination data, stability study data, clinical evaluation data, product risk analysis data etc. of in vitro diagnostic reagents, the original registration application dossiers for the imported medical devices can be submitted. The import registrant and domestic registration applicant shall ensure that the above materials are relevant to and supportive for this registration application.

(III) The registration and application procedures are implemented in accordance with the Provisions for Medical Device Registration, the Provisions for In Vitro Diagnostic Reagent Registration and relevant provisions for electronic Regulated Product Submission (eRPS).

(IV) Where an application for registration is submitted and approved in accordance with the requirements of this Announcement, the column of Remark shall indicate the medical device registration certificate number of the imported product that has been approved for registration.

III. Registration system verification requirements

Registration applicants shall ensure that the main production process of the product is included in the domestic production, commit that there will be no change in main raw materials and production processes, and provide the self-inspection report that the domestic production quality management system of the product complies with the Good Manufacturing Practice for Medical Devices and equivalence 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 comprehensive verification for domestic registration applicants, focusing on the equivalence and traceability of domestic and foreign quality management systems, as well as whether changes in the system caused by changes in the production processes will generate new risks and cause changes in the registered items.

IV. Post-marketing surveillance requirements

Domestic registrants shall apply for the production licenses of medical devices in accordance with the Measures for Supervision and Administration of Medical Device Production, strictly implement the principal responsibility of quality safety, and strengthen the quality management of medical devices throughout their life cycle; and establish and improve the quality management system and ensure its effective operation according to the requirements of the Good Manufacturing Practice for Medical Devices.

V. Other aspects

The production of Class II and Class III medical devices with imported medical device registration certificates in China by overseas registrants invested by domestic enterprises in China can be implemented with reference to this Announcement. The domestic enterprises in China that invest the overseas registrants should apply for product registration as the registration applicants. The matters related to the products with medical device registration certificates obtained in Hong Kong, Macao and Taiwan can be implemented with reference to this Announcement. This Announcement shall be implemented as of the date of issuance.