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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**Overview of UL** UL addresses challenges in safety, security, and sustainability through the application of science, contributing to the creation of a better world. By enabling the safe introduction of advanced products and technologies, UL enhances trust. The staff at UL share a passion for making the world a safer place. From third-party research to standards development, testing, certification, and the provision of analysis/digital solutions, UL aims to build a healthier global society through its operations. The trust in UL supports smart decisions made by businesses, manufacturers, government authorities, regulatory agencies, and individuals. For more details, please refer to the website (UL.com). **Overview of UL Japan, Inc.** UL Japan, Inc. was established in 2003 as the Japanese subsidiary of UL, a global third-party safety science organization. Currently, leveraging UL's global network, it provides conformity assessment services for certification marks required for products in the North American UL mark, as well as safety and EMC certification PSE and S marks based on Japan's Electrical Appliance and Material Safety Law, and certification marks needed for the European and Chinese markets.
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