Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
On August 15, this blog explored some of the specifics surrounding the increased market expansion of the medical device industry in Brazil. But what are the best ways to register a medical device that can be sold in this market? What are the standards required by Brazil?
All medical equipment and devices intended for sale in Brazil must be registered with the Brazilian national health administration agency, the Agencia Nacional Vigilancia de Sanitaria (ANVISA). This agency has enforcement powers similar to the FDA, including cancellation of operation permits for drugs, food, medical and cosmetic products and licensing of manufacturers and distributors.
If a medical device is electrically powered, a company will likely need to obtain INMETRO certification from an authorized Certification Body in Brazil. Also, as of May 2010, ANVISA requires most medical device manufacturers to comply with Brazil’s Good Manufacturing Practice (GMP).
A certified body is a key step in helping a company with INMETRO, modifying existing FDA GMP, or achieving an ISO 13485-compliant system.