(1) The products declared for registration have been defined as Medical Devices or in vitro diagnostic reagents (or in accordance with the above definitions of medical devices or in vitro diagnostic reagents) by the Medical Device Classification Catalogue or the SFDA regulatory documents.

(2) Overseas medical device manufacturers have the licenses listed and certification in the location country.

(3) Personnel handling the medical device registration application shall be entrusted by the production enterprise and have corresponding professional knowledge to be familiar with the laws, regulations, rules and technical requirements for the registration management of medical devices.

(4) The applicant enterprise has completed the registration test of the product, the quality system assessment (if any) and the clinical trial (if any) work.