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Demystifying INMETRO and ANATEL certification for health products




I am sure that you have already asked yourself why Brazil has such bureaucratic processes and that at some point it has already been frustrating receiving the news that the company will have to certify its product/equipment in order to regularize it with ANVISA. Is this all bad?


The global trend is that more and more the requirements by Organs regulatory agencies of different countries are more similar, always seeking to guarantee safety, especially regarding ​​medical products/equipment. We have as an example the MDSAP (Unique Audit Program in Health Products) * which includes countries like Australia, Canada, United States, Japan and Brazil, where, with an unified inspection, it is possible to obtain certification in Good Manufacturing Practices for several countries. This way, it is possible to reach more than one market meeting very similar requirements.


For products under the Health Surveillance regime, INMETRO certification is mandatory because Ordinances 54/2016 and 544/2016, in addition to complementary legislation, bring the requirements for the certification of these products: “These Requirements apply to equipment, including parts and accessories, for medical, dental, laboratory or physiotherapy purposes, used directly or indirectly for diagnosis, treatment, rehabilitation and monitoring in human beings, and equipment for the purpose of beautification and aesthetics”.


Having a product certified by INMETRO not only has the benefit of ensuring that it is safe for the user and the patient, but can also be used by your company as a marketing tool. In addition, it is important to consider that, nowadays, information reaches a large number of people and entities very quickly, therefore, the risk of having your company's image degraded by the marketing of a product that does not comply with the legislation in effect, can become an obstacle for your sales.


For health equipment that transmits data and/or voice by RF or cables, Anatel Certification is also mandatory. The products are classified in 3 categories (1,2 and 3) and the Designated Certification Bodies (OCD) are responsible for evaluating the product and classifying it according to the classifications already defined by the agency.


The certification of INMETRO and ANATEL is carried out by the Certification Bodies accredited / approved by their respective competent entities, whose job is to demystify and show that the process does not need to be as difficult as one thinks and neither as long as expected. The certification process consists of document evaluation, laboratory tests and auditing (applicable, depending on the type of certification) and at the end of the process, the Technical Conformity Certificate is issued by the Certification Body. Certifying is synonymous with reliability and adequacy with health legislation!


* More information about MDSAP at

http://portal.anvisa.gov.br/programa-de-auditoria-unica-mdsap

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