Exporting Medical Devices to Brazil: Seven Step Process (Part 3)
12 September 2011
Over the last few weeks, this blog has explored how manufacturers can ensure that their medical devices are ready for the Brazilian market. Specifically, the last blog on this subject discussed how 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). But what are the steps required to manage a medical device registration process?
There are a total of seven steps that each medical device manufacturer needs to consider before exporting to the Brazilian market. These seven steps include:
- Submission of technical documents to ANVISA.
- Certifying electro-medical devices falling under the scope of IEC 60601-1, performed by an INMETRO (National Institute of Metrology, Standardization and Industrial Quality) Certified Body, enabling a product to obtain the INMETRO Mark of Safety.
- Requiring the Certification Body (CB) test reports so that a product can obtain the INMETRO mark plus the mark of the certifying organization.
- Accomplishing surveillance audit assessments with INMETRO processes. Once your product is certified, it will bear the INMETRO mark. If a device already has a Certification Body (CB) Report, then it is wise to still test any differences between Brazilian national standards that are applicable to an electrical and electronic product.
- Securing a quality management system auditing and certification to ISO 13485:2003
- Completing the annual surveillance assessment of a product required by all manufacturers outside of Brazil to maintain their certification.
- Registering a medical device with the ANVISA medical database. All medical devices shipped to Brazil are checked by Brazilian Customs against the ANVISA medical database for registration requirements and are allowed to enter Brazil only if properly registered.