Re: Medical Equipment Inmetro Certification Process in Brazil
Hi
1st party - manufacturer's own lab.
3rd party - independent test lab.
Your lab would be a 1st party lab. It's not acceptable for Inmetro certification to be accredited by CB-Scheme. You need to be ILAC, EA or IAAC-traceable (we're discussing the CB-Scheme at the moment but this is something for the future).
Hi Marcelo,
I do not fully understand what "3rd party accredited", "1st party accredited", etc. means under Brazilian regulation. Would you mind clarifying further?
Suppose I am a medical device manufacturer. Our lab is not ILAC member accredited but we are accredited by a certification agency under the CB scheme. Which one are we?
Hi
1st party - manufacturer's own lab.
3rd party - independent test lab.
Your lab would be a 1st party lab. It's not acceptable for Inmetro certification to be accredited by CB-Scheme. You need to be ILAC, EA or IAAC-traceable (we're discussing the CB-Scheme at the moment but this is something for the future).