1, business registration
2, business registration application form
3, FDA confirmation, release of the business 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 the product: a) Class 1 medical device listing control
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 the information
Enterprise business license
4, business legal person code certificate, the registration certificate of the association legal person and so on (copy stamped with the official seal of the company) c) Valid qualification certificate or production license certificate (copy with company seal) d) "FDA Registration Application Form" (one copy in Chinese and one copy in English, stamped with company seal) e) FDA new requirements for the submission of other documents (if any). Brief introduction of the enterprise (the time of establishment 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 status , 510 (K), PMA of the FDA to send another letter of approval of access