In Brazil, the Agency for Health Monitoring ANVISA (Agência Nacional de Vigilância Sanitária) is responsible for the registration of medical products. In order to begin the process of registration at ANVISA, we need either an authorized representative or a subsidiary in Brazil. For us, our subsidiary Schoelly Latin America is responsible for representing our products before the registration authorities.
All in all, the registration with ANVISA is cumbersome and the advantages that you have with a registration by an experienced manufacturer are obvious: we take over the complete responsibility for a punctual classification of the medical products according to Brazilian regulations, a successful execution of the registration and for the receipt of the five-year registration certificate.
To attain a registration of electric (active) medical products (field of validity IEC 60601-1) with ANVISA, first an effective INMETRO certification must be shown. To get this, the appropriate test reports must be submitted. As a rule, IEC test reports are sufficient. It can happen, however, that additional demands must be proven through further testing. Additionally, annual factory inspections are carried out at our site, because we are the manufacturer.
Our quality management system must also fulfill specific requirements. Within the framework of a 4 to 5-day long inspection by the ANVISA, checks are made as to whether these requirements are being met. Following a successful inspection, the agency issues an inspection certificate. The inspections take place every two years.
In addition to the INMETRO certification, we must submit technical documentation to ANVISA. Technical documentations, which we have submitted for CE approval in Europe, are generally accepted.
The described proofs and documentations are submitted by our subsidiary to ANVISA for review. Following successful registration, the authorities put the product into the publicly accessible databank and it can be viewed via internet. From this point on, the product can be marketed in Brazil. How long a registration in Brazil takes, depends on different factors. In general we expect a period of six to twelve months.
Of course, we already own the registration for the majority of our standard products in Brazil through our subsidiary. This allows you to immediately start to purchase and distribute products for the Brazilian market.