U.S. Food and Drug Administration
Medical Device is classified into Class I, II, and III, according to the effect on the human body.
In order to export products to the US, actions such as registration, 510(k) (Premarket Notification), PMA (Premarket Approval) need to be taken depending on the type and the Class of products.
Chemron FDA performs various testings, meeting the purpose required by FDA, in connection of the medical device research institute.
Based on the documents and information provided to us, as well as the needs of our clients, we request FDA certification with the assistance of experts specialized in medical device.
Chemron FDA has completed FDA registration and validation of medical device over 400 businesses.
With our accumulated know-how of certification and approval of medical device can become your export partner.
Reference : http://www.fda.gov/MedicalDevices/