Brazilian medical devices and INMETRO certification
Response to Brazil INMETRO
To sell medical devices in Brazil, product registration with ANVISA is required. However, before registering with ANVISA, you must demonstrate the conformity of the relevant products based on the INMETRO conformity assessment program. We have summarized the key points of the latest Ordinance No. 384 and the certification process concisely, so please access the "Related Links" below to assist you when considering entry into the Brazilian market.
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UL Solutions provides support necessary for obtaining certification as an INMETRO product certification body (OCP) in Brazil. Furthermore, for safety testing of target products required for certification (electrical safety, EMC, usability, software) and quality system audits for manufacturers, we conduct safety tests based on ISO 17025, with domestic inspectors who have extensive experience in factory inspections.
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