WalterPeck
Registered
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?
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?