Brazil INMETRO Certification Consulting for Medical Devices

ANSWERED ON THIS PAGE:

• What is Brazil INMETRO certification for medical devices?
• Which devices require INMETRO certification?
• Will our existing medical device tests meet INMETRO requirements?

Some medical devices must be certified by The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) to obtain National Health Surveillance Agency (ANVISA) registration in Brazil. INMETRO certification is often required for electro-medical devices subject to IEC 60601, though it may be required for other product types as well.

Emergo’s staff in Brazil has extensive experience with ANVISA registration and INMETRO certification. We can help you identify the testing requirements for your device.

Electrical safety testing completed outside of Brazil

Many companies located outside Brazil have already completed IEC 60601 electrical safety testing. 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 3^rd edition and the test report was issued within the previous two years. 

Your testing results must still be validated by an INMETRO certifier, but if your test results meet INMETRO’s criteria, it can help expedite the certification process.

Choose Emergo to advise you on INMETRO requirements

Emergo has registered hundreds of devices in Brazil so we understand INMETRO requirements very well. Here’s how we can help:

• If you elect to do testing in Brazil, Emergo can act as a liaison between you and the local INMETRO certifier as part of your medical device registration in Brazil.
• We will oversee your certification and determine if current IEC 60601 electrical safety certification (or other non-electrical certification) is likely to be accepted by the INMETRO certifier.
• If necessary, we can coordinate INMETRO testing by identifying accredited testing agencies and obtaining quotes on your behalf.

Our experienced team in Brazil can assist you with every step of the ANVISA registration process in Brazil.