Mediqol

The Brazilian Regulatory Agency, ANVISA, has recently officially published RDC 25/09 which calls for Brazilian companies (manufacturers, distributors or local agents) registering products in risk class III and IV (medical devices and equipment) and risk class II, III and IIIa (products for in-vitro diagnostics) to request GMP certificates from the device manufacturers (local and international) otherwise the company will not be allowed to register these categories of product in Brazil.

The GMP certificate issued by ANVISA is a mandatory item on the check-list of documents for registration for these products and will be issued after an audit of the respective plant/manufacturing site. Manufacturers will need to pay ANVISA’s fees for the GMP inspection (we are still seeking clarification on these fees) and submit a request for a GMP inspection by ANVISA staff. At this stage we aren’t sure if this is going to lead to a delay in product approvals but we’ll keep you posted with feedback from our client base.

For assistance with registering your products in South America please contact our International Product Registrations expert at sarah.ramsay@mediqol.com