As far as I know ANSM timelines follow the MEDDEV 2.12/1 for vigilance; there should be no difference in the reporting timelines as the MEDDEV document does apply to all European countries.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 12-Jul-2018 15:12
From: Anonymous Member
Subject: Notification to the ANSM for Critical product defect
This message was posted by a user wishing to remain anonymous
Hi,
Is there a time frame laid out as to when a critical product defect has to be notified to ANSM for further actions like potential recall?
Thank you!