Just to add to what Richard wrote, if you made a significant change to your product, then MDSAP report does not replace the requirement to notify the regulatory body (e.g., a 510(k), Health Canada Medical Device License Amendment, etc.).
If it's a change that affects your registration, e.g., address change, a new facility, change to facility type (specification developer to manufacturer), certification scope, etc., these also have to be done separately in accordance with the local requirements.
And as always, it depends on what the changes are. Many changes do not have to be separately notified to regulatory bodies.
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Michael Zagorski RAC
Director of Regulatory Affairs
Pittsburgh PA
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Original Message:
Sent: 11-May-2022 07:46
From: Richard Vincins
Subject: MDSAP - Significant Changes
Anon,
While this may be included in the MDSAP report, the regulatory agencies passively receive a copy of the MDSAP report. If you have any significant changes, these should have been reported individually to each country depending on the regulatory requirements, e.g. using the FDA's determining when to submit a 510(k) guidance document. To answer your question, the process for notifying the Auditing Organisation (AO) for MDSAP of (significant) changes are not equal to notifying the regulatory agency for the country. So yes, it may require further notification because these processes are not linked together.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 10-May-2022 07:30
From: James Bonds
Subject: MDSAP - Significant Changes
Hello Anon,
All of the MDSAP participating countries listed in your MDSAP scope will receive a copy of the MDSAP report, so you can consider that all CAs involved are notified.
Regards,
James
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James R. Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
Original Message:
Sent: 05-May-2022 15:58
From: Anonymous Member
Subject: MDSAP - Significant Changes
This message was posted by a user wishing to remain anonymous
Hello,
There is some confusion for me about what purpose MDSAP audits/reports serve. Are all of the changes reviewed during an MDSAP audit notified to each of the MDSAP countries?
For example, prior to the audit, notification was sent to the auditing body that "X" number of significant changes were made. The changes were reviewed and approved during the audit. Are the changes then approved for each of the MDSAP countries? Does this require further notification or evaluation?
Thank you!