[Analysis][NMPA] The transfer of the production of imported medical devices to Chinese enterprises

On March 5th, 2020, in order to further simplify and optimize the requirements for the licensing of medical devices and meet the needs of the people, the NMPA has drafted the "Announcement on Matters Related to the Transfer of Products That Have Obtained Registration Certificates for Imported Medical Devices to Production in Domestic Enterprises in China (Draft for Comment) ".


1.Scope of application

This Announcement applies to import medical device registrants who set up a foreign-controlled investment enterprise in China, and through which they produce the Class II and Class III medical devices that have received the import medical device registration certificate.


2. Registration requirements

(1)     The registration applicant is a foreign-invested enterprise in China established by the registrant of the imported medical device. According to the medical device product management classification, the applicant for registration shall submit a domestic medical device registration application to the corresponding medical products administration.

(2)     Registration applicants shall submit registration application materials in accordance with relevant requirements.

Among them, review data, research data, clinical evaluation data, product risk analysis data of medical device products; Review data of in vitro diagnostic reagent products, research data of main raw materials, analysis performance evaluation data, positive judgment value or reference interval determination data, and stability Sex research data, clinical evaluation data, product risk analysis data, etc. can be submitted using the original registration information of imported medical devices.

Import registrants and domestic registration applicants shall ensure that the above registration declaration materials are consistent with the original registration declaration materials submitted by the import registrant.

(3)     Formal requirements for registration application materials, such as the submission method, document order, eRPS directory, signature, etc., shall be implemented in accordance with relevant documents.


3. Registration process

Relevant procedures for acceptance, review and approval, which are not specified in this announcement, shall be implemented in accordance with the "Administrative Measures for the Registration of Medical Devices" and the "Administrative Measures for the Registration of In vitro Diagnostic Reagents".


NOTE: Where a registration application is submitted and approved in accordance with the requirements of this announcement, the remark column of the registration certificate shall indicate the medical device registration number of the imported product that has been approved for registration.

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