Hi Shirley,
I appreciate the perspective, and it sounds like Health Canada is moving in the right direction. The timelines I obtained were back in Dec 2021 and we had cc'd the AO. I've provided a snippet of the Health Canada response below:
"I understand but please understand as per the Medical Device Regulations your company will need to submit the new MDSAP certificate before the old MDSAP cert expires, there are no exceptions. The licences could be subject to suspension at any time following the expiry of the supporting MDSAP certificate, however any regulatory action will be preceded by notification in advance of such a decision. Feel free to contact us should you have any questions. I hope that clarifies the situation.
Please note, our current timeline is as follows: Dec 1st, 2021 we will send a Warning Letter giving manufacturer's 30-days to respond with a valid MDSAP certificate should their certificate on file be expired, Jan 1st, 2022 we will send a Suspension Letter giving 30-days to appeal, and Feb 1st, 2021 we will actually suspend licences."
I hope there really is more grace for other manufacturers that are in similar situations.
With kind regards,
Karen
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Karen Fan MSc RAC PEng PMP
EU MDR Consultant
Canada
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Original Message:
Sent: 07-Feb-2022 07:55
From: Shirley Furesz
Subject: Health Canada threatens to suspend mfg MDL at TUV SUD's delay to issue QMS cert
Hi Karen,
I'm not sure if your company is a member of Medtech Canada or not, but they had sent a letter to Health Canada (Fred Hamelin) just recently asking what HC's position was with regards to MDSAP certificates (and licences) that were going to expire and the manufacturer was still waiting for their certificate to be issued. This was Fred's response from just last week:
"Yes, we have resumed our expiry management activities and consequently some manufacturers have received letters of proposed suspension. We are aware of the situation. We have been keeping track of companies that have indicated that they are waiting on the issuance of a certificate. We are in the process of validating the situation with the concerned AOs and inquiring about expected dates of issuance.
Our goal is not suspend the licences of manufacturers who are waiting on a certificate due to delays from their AO."
From my experience (even before COVID slowed things down), HC gives manufacturers lots of warning before actually cancelling a licence if it is due to an expired MDSAP certificate. In some cases it was more than the two months you stated above.
I'm glad you were able to get this figured out with both your AO and HC.
Shirley
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Shirley Furesz RAC
Director, Regulatory Affairs Medical Devices
Oakville Canada
+1 5192426476
sfuresz@tpireg.com
Original Message:
Sent: 04-Feb-2022 12:03
From: Karen Fan
Subject: Health Canada threatens to suspend mfg MDL at TUV SUD's delay to issue QMS cert
The short of it is that TUV SUD issued the updated cert 4 days after expiration. We lived with a planned deviation (and much anxiety) for those days, and had made plans to issue a product recall when Health Canada suspended the MDL.
The process with Health Canada for expired MDSAP certs is as follows: Health Canada first issues a warning to manufacturers from the Quality side, then there's another notification about the upcoming MDL suspension before the actual suspension. Overall 2 months but Health Canada indicated that they could have suspended the MDL any time after QMS cert expiration.
- Ginger - MDSAP Accreditation Committee - Thank you for this suggestion. I emailed them, and the same person from the Quality side provided the actions/timeframe above and indicated that we needed to pester TUV SUD to do their part.
- Richard - Pestering TUV SUD - Thank you for this suggestion. We pestered every week and every day as we got closer, and even had meetings with top management on both sides.
- Kevin - AO Transfer - Thank you for this suggestion. We tried to do an AO transfer with another registrar 6 months prior, but they wouldn't take us until we could give them the A2 surveillance audit report. The previous year's report was delayed, and by the time we received that report, it was too late to schedule the AO transfer audit.
- Should we have bitten the bullet and signed on with a new registrar with a new AO certification audit? The added cost was significant and I don't know if things would have turned out differently if we had a do-over.
I suspect there are a lot of manufacturers / registrars / notified bodies in the same boat.
Write to Health Canada and alert them, especially if you're manufacturing one of these devices (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages.html). Winter is coming.
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Karen Fan MSc RAC PEng
EU MDR Consultant
Canada
Original Message:
Sent: 10-Dec-2021 12:08
From: Kevin Randall, RAC
Subject: Health Canada threatens to suspend mfg MDL at TUV SUD's delay to issue QMS cert
When encountering this type of situation in recent years, I've repeatedly solved the problem by switching to a different Auditing Organization (AO). I was always careful to do this as a "transfer" of the current certificate to the new AO. In so doing, the new AO is able to issue its new certificate via a relatively abbreviated mechanism. Such transfers are pursuant to the corresponding provisions of the ISO standards by which the AOs are governed. But since the TUV certificate expired on 2021-Dec-05, the transfer route may no longer be an option in this case; my apologies I wasn't able to respond to your question sooner. It would still be worth a shot in my opinion to see if a new AO might nonetheless consider a transfer; but it's probable that the governing ISO process won't permit transfer of an expired certificate. At the very least, you can file this strategy in your future rainy-day kit.
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Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 03-Dec-2021 11:39
From: Karen Fan
Subject: Health Canada threatens to suspend mfg MDL at TUV SUD's delay to issue QMS cert
One of the companies I work for is struggling to obtain an updated QMS certificate from TUV SUD Americas Inc. and I'm wondering if anybody has experienced a similar issue. At TUV SUD's delay to issue an updated QMS certificate, Health Canada is threatening to suspend my client's medical device device licence (MDL) [thereby threatening my client's ability to sell medical devices in Canada].
The certificate currently expires 2021-Dec-05.
As background, TUV SUD Americas Inc. completed the re-certification audit on 2021-Aug-12 and recommended continuation of the QMS certification in the audit report. There were no 4s or 5s, and all corrective action plans have been approved. This client is in good standing with both TUV SUD and Health Canada, and has done its utmost to comply with the Medical Device Regulations. We have reached out multiple times to multiple TUV SUD staff at multiple levels of the organization including SVP and VP, with no success.
The company has also reached out to Health Canada, and they will not accept a bridge letter in lieu of an updated QMS certificate. They've also indicated that "Health Canada can suspend the MDL any time the QMS cert expires".
Is there anybody that can help?
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Karen Fan MSc RAC PEng
EU MDR Consultant
Canada
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