What Is A Certified Product?


2021-11-05

The production date of the product is within the validity period of the registration certificate, and it is regarded as a certified product. Imported products produced outside the valid period of the registration certificate shall be regarded as unlicensed products and cannot be imported.
Approved medical devices for registration refer to medical devices consistent with the contents of the medical device registration certificate and accessories and manufactured within the validity period of the medical device registration certificate.
Refer to Article 112 of the “Administrative Measures for the Registration and Filing of Medical Devices.”
Takeaway:On Sep 2, 2021, NMPA officially mentioned that imported products produced outside the valid period of the registration certificate shall be regarded as unlicensed products and cannot be imported.