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New INMETRO Ordinance 384 – Certification for Medical Devices

Understand the new INMETRO healthcare product certification ordinance for Brazil.

Lab technician testing a medical device.

March 30, 2021

On Dec. 18, 2020 INMETRO published a new regulation intended to update the current requirements for medical device certifications. The changes aligned some points in the Brazilian certification process with other international certification models. This includes the acceptance of  manufacturer valid QMS certification and changes the criteria for test report acceptance. 

On Feb. 24, UL’s Victor Bastos (sales manager for Latin America) led a webinar concerning the new INMETRO regulation for medical device certification in Brazil, and discussed topics such as:

  • Overview of ANVISA and INMETRO
  • Transition period for certifications under Ord. 54 and 350
  • Products under 384:2020 scope
  • General certification process
  • Audit at manufacturer and applicant location 

After the discussion, Victor answered numerous questions from participants during the Q&A session.

View the webinar to learn more or contact us with any questions.


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