INMETRO certification for electrical medical devices Gain access to the lucrative Brazilian market.
Your challenges INMETRO Certification is one of several complicated prerequisites that medical device manufacturers must fulfil to register their products in Brazil. Many manufacturers do not have a detailed understanding of the regulations involved in certification. They may also be unaware of the need of having a Legal Representative in Brazil. Communication between all parties involved can be complicated due to cultural and language barriers, as well as a lack of understanding of local regulations. For all these reasons, manufacturers intending to gain access to the Brazil market can benefit from partnering with an independent testing and certification provider that offers the necessary regulatory expertise and local knowledge.
What is INMETRO certification? Manufacturers wishing to market their electrical devices in Brazil must have their products registered with the competent national authority, ANVISA, which is the Brazilian
TÜV SÜD America
Health Surveillance Agency. To become registered with ANVISA, most electrical medical devices require INMETRO certification.
Why is INMETRO certification important for your business? Having a product certified by INMETRO provides assurance that it is in compliance with Brazilian regulations and required safety standards. Most electrical medical devices must have INMETRO Certification as a prerequisite for registration at ANVISA. Registration at ANVISA is a mandatory step for introducing a product to the market in Brazil.
How can you prepare for INMETRO certification? Manufacturers’ test reports may be outdated or they may involve a test lab that is not recognized. Only test reports issued by organizations that are accredited by either INMETRO or members of internationally recognized forums