IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in...
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 3rd 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.
Common questions
How long does it take to get INMETRO certification if we do not have testing reports less than two years old?
The certification will generally start after you finish updating your test reports. Some certifiers allow you to work on the certification in parallel to the testing. In the latter case, the whole process would typically take 5-6 months if no major issues are detected during the testing and certification processes.
Do the testing reports need to be less than two years old at the time we submit our registration to ANVISA, or when ANVISA finally reviews our submission?
Neither. The test reports must be less than two years old to apply to the INMETRO certification process, which is done prior to the registration itself. ANVISA only considers the date of issuance of the INMETRO certificate when reviewing registration applications.
What are some other non-electric medical products that require INMETRO?
Needles, syringes, mattresses, gloves, breast implants, mechanical wheelchairs, hand pieces, and infusion sets.
Can the testing be done outside Brazil or do I have to use a lab in Brazil?
For the certification of electro medical devices, the testing can be done outside of Brazil, which is often recommended. For other products, in country testing in Brazil is required.
How long is the INMETRO certificate valid?
The INMETRO certificate is valid for five years and then it must be renewed.
When will I receive the INMETRO inspection?
After the certifier is chosen and the proposal is signed, the certifier will schedule the best date for the inspection to take place with the manufacturer. After this initial audit, there will be annual maintenance inspections throughout the validity of the certificate.
Who will be inspected: the legal manufacturer or the actual manufacturer?
The actual manufacturer will be inspected. If there is more than one, all manufacturing sites must be inspected.
Listen to our 4 minute audio podcast interview on INMETRO certification in Brazil:
Interested in learning more about INMETRO certification in Brazil? Emergo's Ann Marie Boullie, Vice President of Business Development, and Tatiana Sell, International Projects Manager, discuss some of our most frequently asked INMETRO questions in this podcast interview.
Frequently Asked Questions
How long does it take to get INMETRO certification if we do not have testing reports less than 2 years old?
The certification will generally start after you finish updating your test reports. Some certifiers allow you to work on the certification in parallel to the testing. In the latter case, the whole process would typically take 5-6 months, if no major issues are detected during the testing and certification processes.
Do the testing reports need to be less than 2 years old at the time we submit our registration to ANVISA, or when ANVISA finally reviews our submission?
Neither. The test reports must be less than 2 years old to apply to the INMETRO certification process, which is done prior to the registration itself. ANVISA only considers the date of issuance of the INMETRO certificate when reviewing registration applications.
How do I know if our testing lab is ILAC certified?
You have to know what certifying body certified the testing lab. Once you have this name, go to the ILAC website (http://ilac.org/signatory-search/) and look for the certifying body.
What are some other non-electric medical products that require INMETRO?
Needles, syringes, mattresses, gloves, breast implants, mechanical wheelchairs, handpieces and infusion sets.
Can the testing be done outside Brazil or do I have to use a lab in Brazil?
For the certification of electro medical devices, the testing can be done outside of Brazil. This is the route that we most recommend. For other products such as needles, condoms, etc., in country testing in Brazil is required.
How long is the INMETRO certificate valid?
The INMETRO certificate is valid for 5 years. After 5 years is up, the certificate has to be renewed.
When will I receive the INMETRO inspection?
After the certifier is chosen and the proposal is signed, the certifier will schedule the best date for the inspection to take place with the manufacturer. After this initial audit, there will be annual maintenance inspections throughout the validity of the certificate.
Who will be inspected: the legal manufacturer or the actual manufacturer?
The actual manufacturer. If there is more than one, all manufacturing sites will have to receive the inspections.
