Dear Anon,
As the manufacturer of the device "part" or an integrated Combination Product with a Drug PMOA, you are a component manufacturer and not a medical device manufacturer. The drug company that will register and manufacture the final Combination Product is responsible for compliance with the drug GMPs, which may include requiring appropriate Quality Systems from their component manufacturers.
These quality systems do not NEED to be certified, and if they are, do not NEED to be issued by third party auditing organizations. Whatever is required is part of their GMP supplier controls and should be documented in a contractual agreement with the drug company.
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Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States
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Original Message:
Sent: 06-May-2024 07:43
From: Anonymous Member
Subject: Quality system requirements for drug device combination in Canada
This message was posted by a user wishing to remain anonymous
Dear all,
For medical devices the Health Canada only accepts the quality system certificates that have been issued by third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.
Is the same approach applicable also for manufacturers of device part of integral drug device combination product, where the drug have the principal mechanism of action?
Thank you in advance.
Best regards!