: 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