Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts.
Imported medical device registration shall perform “Imported Medical Device Registration Testing Regulation”.
applying medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institution.
technical supporting material that shall be inspected by SFDA, finally SFDA will give a decision.
catalog changes, manufacturers shall apply for alteration and re-register according to the changed catalog in concerning regulatory authority of the government.
Literal alteration of product name and trade name.
Applicant documentation requirements of medical device certificate alteration
Include manufacturing license, Counterpart of Business License, and the applying products falls into the approved manufacturing scope of manufacturing license;
registration standard, the report shall be signed by main testing personnel or main testing responsible personnel, and auditor.
responsibilities of entering into market, and a classification illustration of concerning product models, specifications.
If falling into this method Clause 33, please submit original medical device registration copy certificate. If falling into this method Clause 34 and Clause 35, please submit the original medical device registration certificate.
in China and the user manual of Class I does not need to be singed.
report bad events of medical device and be responsible to communicate with food drug administration.
The user manual of Class II and Class III shall be singed by manufacturer or its agency located in China and the user manual of Class I does not need to be singed.
All the files above mentioned shall have Chinese version. For the annex 2 and 4, the files would be copies, but have to be notarized by original organization that issuing them or by local notary public. Other files in this annex must be submitted the original files signed by manufacture or its office in Beijing or representative.
abilities (testing resources are included.)
responsibilities by manufacturer.
its representative in China )