Yes, Brazil's National Health Surveillance Agency (ANVISA) may accept CE marking approval as a reference for medical device and diagnostics registration under certain conditions. ANVISA recognizes that the CE marking demonstrates compliance with the European Union's (EU) regulatory requirements for medical devices, which cover safety, performance, and other essential characteristics.
However, it's important to note that ANVISA has its own specific requirements for the registration of medical devices and diagnostics in Brazil, which may differ from those of the EU. While CE marking approval can be a valuable reference, it does not automatically guarantee registration with ANVISA.
In practice, when applying for registration in Brazil, manufacturers can use their CE marking approval as part of the technical documentation to demonstrate compliance with certain aspects of ANVISA's requirements. This may help streamline the registration process by providing evidence of conformity to recognized international standards.
However, ANVISA may still require additional information or documentation specific to Brazil's regulatory framework. Manufacturers should carefully review ANVISA's regulations and guidance documents to ensure that they meet all the necessary requirements for registration, even if they already have CE marking approval. Working with a local representative or regulatory consultant familiar with ANVISA's processes can also be beneficial in navigating the registration process effectively.
