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. This is the case for medical equipment, hypodermic needles, hypodermic syringes, gloves, condoms, and others, which will require the National Institute of Metrology, Quality and Technology (INMETRO) certification. 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. The National Telecommunication Agency (ANATEL) is another Brazilian authority. It deals with safety related to medical devices’ telecommunication and/or accessories that have any wireless communication, eg. bluetooth, wifi, etc. If a medical device requires INMETRO or ANATEL certification, the certificates, issued by a Brazilian certification body, will be mandatory before submitting your product registration to ANVISA.

DOMO Salute team has a deep knowledge on INMETRO and ANATEL requirements and can coordinate all the paths of your product`s certification, including obtaining quotes on your behalf. We can support you by choosing a certification body and act as a liaison between you and the local INMETRO and/or ANATEL accredited body. We can analyze all documents your product already has in order to identify if it fits the Brazilian requirements, e.g IEC 60601 test reports.

Our team also has a lot of experience managing the testing process, suggesting the best option among accredited testing laboratories and accredited certification bodies. Our engineers have successfully supported many medical devices companies obtaining INMETRO and ANATEL certificates in a smoother and quicker way.