Medical Device Registration Services - United States

Regulatory Department

The Center for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA)

Regulation

21 CFR Part 800-1299

Regulatory Classification & Registration Process

Class I – Lowest Risk

  • 510(k) Premarket Notification (Exemptions may apply)

  • De Novo Classification Request required for novel medical devices

  • Timeframe: 1 month

Class II

  • 510(k) Premarket Notification (Exemptions may apply)

  • De Novo Classification Request required for novel medical devices

  • Timeframe: 9-12 months

Class III – Highest Risk

  • Premarket Approval Application (PMA)

  • Humanitarian Device Exemption (HDE) may apply to certain humanitarian use medical devices

  • Timeframe: >12 months

* An American representative is required to represent overseas medical device manufacturers. We will be able to manage this for you.

Looking to register your medical device in the United States? Contact us today!