INMETRO

Depending on the product’s features, certifications in other Regulatory Agencies may be needed in order to meet the Brazilian regulation and get ANVISA’s approval. INMETRO certification is often required for electro-medical devices subjected to IEC 60601, though it may be required for other product types as well.

The process then involves a systematic procedure attesting a certain degree of confidence regarding the medical device`s (that must meet pre-established technical standards, requirements and regulations) quality and safety.

 If a medical device requires INMETRO certification, the certificate, issued by a Brazilian certification body, will be mandatory before submitting your product registration to ANVISA.