Hello Anon,
As Bryndis said, all Medical Device Licenses (MDL) which is Class II, III, and IV require a MDSAP certificate which is the audit of the quality system. There was a pilot programme initiated by US FDA and Health Canada that the eSTAR process could be used for both US and Canada, e.g. a 510(k) and MDL at the same time. This was a limited participation and not sure if as part of the eSTAR pilot the MDSAP certificate would also need to be uploaded ... I am assuming it would be. Unfortunately, Health Canada took a wrong tack in my opinion and so application for a MDL does require MDSAP certification. Maybe someone who participated in the pilot could provide information if indeed the MDSAP certificate needed to be uploaded.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 11-Jan-2024 04:47
From: Bryndis Gudnadottir
Subject: Health Canada Certificate Requirement
Class II and higher devices all have to have MDSAP certification , Medical Device Single Audit Program (MDSAP) - Canada.ca
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Bryndis Gudnadottir
Reykjavík
Iceland
Original Message:
Sent: 10-Jan-2024 07:31
From: Anonymous Member
Subject: Health Canada Certificate Requirement
This message was posted by a user wishing to remain anonymous
Hello- I was wondering if there were any options for a Class 2 MDL for a medical device that does not have an ISO or MDSAP certificate (has 510k clearance). I assume that there is no bending of this rule but thought that I would still ask so I am less familiar with Health Canada. Thank you.