This message was posted by a user wishing to remain anonymous
Hello,
We just finished the INMETRO audit under the Ordinance 384 and what we experienced were:
- The certification body issued the INMETRO certificate under the Ordinance 384 within the regular audit process.
- The new INMETRO certificate has no expiration date. My understanding is that now the regular audit is what is necessary to keep the INMETRO certificate. No renewal is necessary from now.
Best,
Original Message:
Sent: 05-May-2021 07:47
From: Rashmi Pillay
Subject: ANVISA ordinance 384
Hi,
Has anybody reviewed the full impact of this ordinance? We were informed that the validity of the test reports which earlier had to be nmt 2 years old is now no longer mandatory. Is there any other impact ?
Thanks & Regards,
|  | Rashmi Pillay Regulatory Affairs Manager Ellex – Lumibird Medical group 3-4 Second Ave, Mawson Lakes SA 5095
Tel. +61 8 7074 8105 Email rpillay@ellex.com |
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