Theoretically speaking, it is generally optional to employ recognized standards to show conformity with the safety and effectiveness requirements (sec. 10-20) and/or labeling requirements (sec. 21) of the Canadian Medical Devices Regulations (SOR/98-282). But for practical intents and purposes, the device licence approval process will likely be an easier road when conforming with recognized paradigms instead of home-grown solutions.
On this topic, Health Canada has stated,
"…Conformance with recognized standards is voluntary for manufacturers. A manufacturer may choose to demonstrate conformance with a recognized standard or may elect to address the relevant issues in another manner.
If a standard is recognized, a manufacturer applying for a licence for a device to which that standard applies must either:
-
-
- meet the standard; or
- meet an equivalent or better standard; or
- provide alternate evidence of safety or efficacy
In case the manufacturer chooses option (b) or (c), detailed information must be submitted with the device licence application. If the manufacturer does none of the above, a licence will not be issued…"
Health Canada has stated that it believes that conformance with recognized medical device standards, in whole or in part, can provide assurance of safety and effectiveness for those aspects of medical devices addressed by the standard. Health Canada states that the use of recognized standards can improve consistency in the interpretation of the Regulations and may eliminate the need to review the actual test data for the aspects of the device addressed by the standard. Yet Health Canada also recognizes that recognized standards may not fully address all elements of a device's safety and effectiveness, especially for new types of devices and emerging technologies. And again, application of such standards is generally voluntary. Thus, in the absence of declaring conformity to a recognized standard, a consequence is that Health Canada will, where required commensurate with device risk class, require submission and review of the actual test data needed to show conformity with the safety and effectiveness and/or labeling requirements.
For standards recognition, Health Canada undergoes a public consultation process as part of adding or removing standards from its recognized list. See https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices.html Not sure of the parameters governing the frequency of this process; perhaps others in the forum can elaborate.
Finally, remember also the Food and Drugs Act caveat in Part I (Section 21) stating that, where a standard has been prescribed for a device, then no person shall label, package, sell or advertise any such device unless it complies with the prescribed standard. But compliance with such officially-prescribed standards is not to be confused with (yet may overlap) the application of the aforementioned voluntary standards from the recognized standards list.
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.comNote that I'm now far older and even uglier than in the photo above. Brace yourselves for my updated photo coming soon.
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 20-Aug-2020 08:39
From: Karen Zhou
Subject: Health Canada's List of Recognized Standards
Hi everyone,
I have a question regarding Health Canada's List of Recognized Standards ( https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance.html ) . A few questions:
1. What determines whether a standard is recognized by Health Canada? For example, what is the reason for not including some standards such as the international labelling standards (e.g. ISO 15223-1)?
2. How often does this list get updated?
3. What are the implications of using standards not recognized by Health Canada? (e.g ISO 15223-1).
Thanks.
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Karen Zhou
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