1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Is there any Brazilian biosafety standard or regulation?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by yzl1018, Dec 18, 2021.

  1. yzl1018

    yzl1018 New Member

    Joined:
    Dec 2, 2019
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    Hello guys!
    We will have a MDSAP audit soon.

    During the recent ISO 13485 audit, our auditor pointed out that we should comply with Brazilian biosafty regulations that require to attach biosafety identifiers in our lab.

    Then, I check up on Brazilian GMP regulation.

    It stipulates below requirement:

    5.1.3.6 Biological safety standards shall be observed in the cases where there is biological risk.

    Is it a specific Brazilian standard or other international recognized standard?