1, business registration
2, business registration application form
3, FDA confirmation, the release of the enterprise serial number; 1.2.Product Registration
1 medical device products are divided into three categories in terms of the degree of risk to the safety of: a) Class 1 medical device listing control
2 Class 2 Market Access Approval (ie. 510 (K) approval) c) Class 3 PMA pre-entry approval 1.2.2 Entrusted agent
"FDA Registration and Notification Entrustment Agreement" (signed by the legal representative, stamped with the company's official seal) 1.2.3 Provide information
Enterprise business license
4, business legal person code certificate, the registration of legal person of the association, etc. (copy stamped with the company's official seal) c) Valid period of qualification certificate or production license certificate (copy with the company seal) d) "FDA Registration Application Form" (in Chinese, English each one, stamped with the company seal) e) FDA new additional requirements for the submission of other documents (if any). Brief introduction of the enterprise (the establishment time of the enterprise, economic performance, technical force, the main production varieties and their performance, asset status).
5. Registration and listing are free of charge;
510(K) and PMA are required to pay according to the fee schedule published by FDA online.
6, for registration
7, calculated after the fee, the FDA 60 working days to complete the registration;
8, the FDA website published to inform the registration, 510 (K), PMA of the FDA to send another letter of approval of access