INMETRO Certification

The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) is Brazil's Standards Regulatory Agency. Medical devices with electrical components and some non-electric devices, including needles, syringes, mattresses, gloves, breast implants, mechanical wheelchairs, handpieces and infusion sets, must be certified by INMETRO in order to obtain National Health Surveillance Agency (ANVISA) registration in Brazil. INMETRO certifiers typically accept electrical safety certifications from foreign testing agencies if they were performed by International Laboratory Accreditation Cooperation (ILAC)-certified laboratories to IEC 60601 3rd edition and the test report was issued within the previous two years. The INMETRO certificate is valid for 5 years. After 5 years is up, the certificate has to be renewed.

Test process

• Communicate and confirm the application at the early stage of the project
• Sample sending test
• Test and issue the test report
• Factory inspection
• Submit test report and audit report to the certification authority
• Issue certificate after the approval of the data

STEMart has extensive knowledge of INMETRO requirements and can help manufacturer obtain INMETRO certification.

What We Do

We take you through the step-by-step process to make sure your product is fully certified to be sold in the Brazilian market. The following are services we provide to expedite certification projects:

• Provide guidance in preparation for certification submittal
• Identify requirements that are not applicable under specific conditions
• Identify when one sample can represent a family
• Align certification programs to our customer's needs
• Identify a responsive and reputable in-country representative
• Submittal of IECEx technical package
• Assistance with the documentation package for the in-country applicant
• Advice on preparing manuals, QA and QMS documentation
• Co-ordination of site audit by the CSA Group auditing team
• Regular project calls with you and our partners

STEMart has a solid grasp of regulatory requirements along with the background to properly manage your INMETRO certification projects. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.