United States Of America
REGULATORY AUTHORITY: The US Food and Drug Administration (FDA) is responsible for the pre-market approval of all medical devices, as well as overseeing the manufacturing, performance and safety of those.

CLASSIFICATION SYSTEM: Medical devices are divided into Classes I, II and III.

TIMEFRAME: The FDA review process takes 90 days for 510(k), 30 days for 513(g) and 180 days for PMA.

LICENSE VALIDITY: Annual establishment registration is required.   

AUTHORIZED REPRESENTATIVE: A United States agent is required.

Last updated on February 15, 2017.



ARE YOU INTERESTED IN REGISTRATION IN THE UNITED STATES? REQUEST A FREE QUOTE>​

For​ more information on registration in the United States, check out the following articles on our blog:
5 Questions and Answers: New FDA GUDID Requirements
Case Study: Finding the Golden Mean for Class III Medical Device Registration with the USA FDA
5 Questions and Answers: Recent Requirements for Medical Devices in the USA
 
 
 
latest news
  • Nov 23 2017
    REGULATORY UPDATE - XERIDIEM

    Taiwan: Xeridiem's Entuit ENFit Standard was approved for sale with LICENSALE.COM®. ...

    Read More
  • Nov 23 2017
    REGULATORY UPDATE - VAREX IMAGING CORP.

    Italy: Varex Imaging's X-ray Tube and detector were approved for sale with LICENSALE.COM®....

    Read More
  • Nov 14 2017
    REGULATORY UPDATE - PERFLEX

    Canada: Perflex's Class II Denture Materials were approved for sale with LICENSALE.COM®....

    Read More
  • Nov 6 2017
    REGULATORY UPDATE - VAREX IMAGING CORP.

    China: Varex Imaging's Wuxy was approved for sale with LICENSALE.COM®....

    Read More
  • Oct 26 2017
    REGULATORY UPDATE - VAREX IMAGING CORP.

    China: Varex Imaging's X-ray Tube was approved for sale with LICENSALE.COM®....

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP