INMETRO & ANATEL Certification

Depending on the features of your product, certifications from other regulatory agencies may be necessary to comply with Brazilian regulations and obtain approval from ANVISA. This is particularly relevant for medical equipment such as hypodermic needles, hypodermic syringes, gloves, condoms, and others, which often require certification from the National Institute of Metrology, Quality, and Technology (INMETRO). INMETRO certification is typically mandated for electro-medical devices subject to IEC 60601 standards, but it may also be necessary for other product types. The certification process involves a systematic procedure to ensure a certain level of confidence in the quality and safety of the medical device, meeting predefined technical standards, requirements, and regulations. Another regulatory authority to consider is the National Telecommunication Agency (ANATEL), which oversees safety standards for medical devices with telecommunication features or accessories incorporating wireless communication technologies such as Bluetooth or Wi-Fi. If a medical device requires INMETRO or ANATEL certification, certificates issued by a Brazilian certification body are mandatory before submitting the product registration to ANVISA. DOMO Salute's team possesses extensive knowledge of INMETRO and ANATEL requirements and can manage all aspects of your product's certification process, including obtaining price quotes on your behalf. We assist in selecting a certification body and act as an intermediary between you and local INMETRO and/or ANATEL accredited bodies. Additionally, we analyze your product's existing documentation to ensure compliance with Brazilian requirements, including IEC 60601 test reports. Our experienced team excels in managing the testing process, recommending the best options among accredited testing laboratories and certification bodies.