Health Canada modifies MDSAP transition process
13 April 2018
Clarification - Manufacturers undergoing a full MDSAP audit in 2018
Manufacturers undergoing a full MDSAP audit in 2018 are expected to submit a valid MDSAP certificate with a form F202 (Submission of a New or Modified Quality Management System Certificate) to the Medical Devices Bureau by December 31st, 2018. However, Health Canada will not take enforcement action against manufacturers that can demonstrate that they have undergone an MDSAP audit in 2018, but have not received an MDSAP certificate by December 31, 2018. The Department recognizes that some manufacturers are facing challenges in scheduling MDSAP audits in 2018, and may not be issued their MDSAP certificate by December 31st, 2018 (as there is often a delay between the timing of the audit and the issuance of the certificate).
Maintenance of certification cycles through the MDSAP transition
To facilitate a timely transition to MDSAP, manufacturers who underwent an initial recertification audit to ISO 13485 under CMDCAS (on or after January 1, 2016), will now be allowed to transition into the MDSAP during the surveillance audit process. This will allow manufacturers to maintain their existing certification cycles. These manufacturers will need to demonstrate that they continue to hold a valid ISO 13485 certificate issued by an MDSAP Auditing Organization.
Manufacturers who transition to MDSAP during a surveillance audit will not receive an MDSAP certificate in 2018. However, this option provides manufacturers who would have been otherwise unable to transition before December 31, 2018, with the ability to continue selling their medical device(s) in Canada until they receive a MDSAP certificate.
Please note that manufacturers will only benefit from the international acceptability of an MDSAP once they obtain an MDSAP certificate (following a full certification audit).
Criteria for manufacturers seeking to transition to MDSAP via a surveillance audit
Manufacturers transitioning to MDSAP during a surveillance audit need to demonstrate to Health Canada that:
- They have undergone an initial or recertification audit to ISO 13485 under CMDCAS on or after January 1st, 2016
- They hold a valid ISO 13485 certificate issued under CMDCAS that has a validity period to at least December 31st, 2018
- As of January 1st, 2019, they continue to hold a valid ISO 13485 certificate (non-CMDCAS) issued by an MDSAP Auditing Organisation, and
- They have undergone an MDSAP surveillance audit or have made arrangements to undergo an MDSAP audit.
Documents required for transition to MDSAP via a surveillance audit
Manufacturers who wish to transition to MDSAP during a surveillance audit will also need to provide the following documents to the Medical Devices Bureau using form F202 by December 31, 2018:
- A valid ISO 13485 certificate under CMDCAS issued after January 1st, 2016 and valid to at least December 31st, 2018
- A valid ISO 13485 certificate (non-CMDCAS) issued after January 1st, 2016 by a MDSAP Auditing Organisation, and
- An MDSAP Surveillance Audit Confirmation Notification for a MDSAP surveillance audit having taken place in 2018 (This Notification should be prepared in accordance with MDSAP AU G0026.1 (Surveillance Audit Confirmation Notification Process) or evidence that they have made arrangements to undergo an MDSAP audit (e.g. signed certification agreement)
Questions or concerns regarding this Notice should be directed to:
Quality Systems Division
Medical Devices Bureau
Health Canada
Holland Cross, Tower A
11 Holland Avenue
Address Locator: 3005B
Ottawa, ON
K1A 0K9
Telephone: 613-948-7194
E-mail: hc.qs.mdb.sc@canada.ca
Source: Health Canada website.