Medical

Argentina

General country-specific regulatory information is provided on this page. Become a user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

Medical

Brazil

Appointing a Brazilian Registration Holder Foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian Registration Holder (BRH). Your BRH will submit your registration application to ANVISA and maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable. …