FDA medical Certificate of registration 注册证书  註冊證書
  • All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31.

  • All establishments required to register must pay the user fee before registration. 

$379

Expedited (2-Day)

 

Medical Device Establishment Registration and US Agent Service 

  • We provide FDA User Fee account for you to make payment.

  • $100 refund if you do not receive Owner Operator Number in 2 days.

  • Medical device establishment registration or modification.

  • ​US agent or Correspondent communication service (During same FDA Fiscal Year). 

  • ​Include free electronic certificate.

  • Free modification or renewal during service period.

We encourage you to schedule consultation for better understanding of FDA compliance.