Registration of Imported-to-domestic Products

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.

(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

The same as the regular medical device registration process.