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
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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 Manufacturers’ test reports may be outdated or they may involve a test lab that is not recognized.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
B enefit from an expert partnership – with in-depth understanding of the latest changes and updates to the various guidelines and regulations. E njoy global support – with our international reach and high level of laboratory expertise, combined with our indepth knowledge of local requirements.
Why choose TÜV SÜD?
How can we help you? TÜV SÜD is one of the world’s largest independent providers of testing and certification services. With our complete knowledge of local legislation, guidelines and standards, we assist you to achieve compliance for your medical devices within the Brazilian market.
Our INMETRO certification services TÜV SÜD is accredited by INMETRO as a Certification Body (CB) for electrical medical devices. We provide INMETRO initial certification and annual maintenance. Our clients can choose to have factory inspections carried out parallel with other inspections (NRTL) or audits (ISO 13485/MDD). We also offer medical device testing in compliance with INMETRO requirements.
Your business benefits G ain access to the Brazilian market – by successfully achieving INMETRO certification. S ave time – by synchronizing testing and inspections combined with other programs. M inimize risk – by involving us early in the product design stage. We can provide our services through the entire certification process and from the onset, giving you a competitive edge.
With our global network of strong multidisciplinary expertise, we offer you a personalized one-stop solution, fitting all your requirements and market standards. We offer extensive knowledge of the relevant market regulations, standards and testing and conformity requirements so that you can keep your products in line with the latest regulatory developments.
Choose certainty. Add value. TÜV SÜD is a premium quality, safety and sustainability company that specializes in testing, inspection, auditing and certification. Represented in over 800 locations worldwide, we hold accreditations in Europe, the Americas, the Middle East, Asia and Africa. By delivering services to our customers, we add tangible value to businesses, consumers and the environment.
Related services TÜV SÜD provides the following related services: M edical device testing according to INMETRO requirements Medical Device Single Audit Program (MDSAP) covering Brazilian GMP requirements
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such as IAAC, EA or ILAC are accepted for INMETRO certification. The regional office will require information regarding your company, manufacturer and product, as well as technical documentation. You need to nominate a Legal Representative, which is a Brazilian based company that will represent your product in the market. The certification service will start after the approval of the Legal Representative.
TÜV SÜD has a strong reputation as one of the largest independent providers of testing and certification services. We are also renowned as a specialist in testing products in their intended operating environment. Our widely recognized TÜV SÜD certification marks help you to demonstrate your commitment to safety, adding value to your products and promoting trust among consumers.