Brazil INMETRO recertification

[WalterPeck]

I am currently working on INMETRO re-certification for several medical devices. As I do not have much expertise in Brazil, I am relying on our in-country representative to communicate the requirements for this process. However, they have previously communicated information that turned out to be incorrect in this process so I'm looking to get verification from others here who might be able to help.

We have submitted a 60601-1-2 test report compliant to the latest recognized ABNT NBR standard and this testing was carried out as appropriate by an ILAC accredited lab. Our representative is saying that the INMETRO certifying body has requested every document we reference as evidence of compliance to the various clauses of 60601-1-2 in the report issued by the ILAC lab. Does the INMETRO certifying body actually need to see and review all of these documents if an ILAC accredited lab has already issued us this report stating that we comply with the 60601-1-2 version that is required by INMETRO? Does anyone know where I could find/review the regulation governing INMETRO recertification requirements?

 

[kys123]

Hey Walter,

The regulations which state the requirements for INMETRO certifications and recertifications are currently INMETRO's PORTARIA Nº 200/2021 and Anvisa's RDC 549/21, but I'm afraid official english versions are currently unavaible.

I'm definitely not an expert on the inner workings of INMETRO OCPs but maybe what you're looking for is stated in item 6.2.4.3.3 of Portaria 200/2021? "In the case of use of a laboratory accredited by a signatory of the ILAC or IAAC mutual recognition agreements, it is the responsibility of the OCP to observe and document the equivalence of the method and test parameters."

I'd be happy to assist if you have any more questions.