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.
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.