Intertek provides expert guidance for navigating Brazil’s medical device regulations
Achieving compliance with Brazil’s INMETRO Ordinance 384/2020 is essential for medical devices entering this significant market. Intertek offers comprehensive solutions to address the ordinance’s detailed requirements, including testing, certification, and audit processes tailored to medical devices. These regulations ensure products meet strict safety, performance, and quality standards enforced by INMETRO and ANVISA.
The ordinance outlines specific requirements, such as the proper application of the INMETRO Conformity Identification Seal and updated processes for maintaining certificates of conformity. With no expiration date on certificates, ongoing compliance relies on regular audits and adherence to current technical standards. Intertek facilitates testing and documentation that align with these requirements, ensuring your devices are ready for the Brazilian market.
Manufacturers must also comply with evolving audit procedures, including Quality Management System reviews and Risk Management assessments. Intertek’s capabilities extend to testing against the latest technical standards and adapting to complex regulatory landscapes. This approach helps manufacturers meet all necessary criteria for successful market entry.
Intertek’s expertise ensures alignment with Brazil medical device regulations, streamlining the path to compliance while addressing all key aspects of the INMETRO ordinance. From product testing to certification, we deliver precise and efficient solutions that prepare your devices for success in Brazil.
Download our free Market Guidance Document for medical device regulatory requirements in Brazil. This guide outlines the compliance assessment steps in accordance with Ordinance 384/2020, the standard for the safety and performance of electronic medical equipment.
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** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.