Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices
From Health Canada
Current status: Open
This consultation will be open from September 11, 2018 until November 9, 2018 (60 days from the date publication).
Health Canada is proposing changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices and is seeking input from stakeholders to complete the annual update.
The proposed changes include:
- removing 20 standards
- adding 15 new standards
- replacing previous editions with 12 new editions of currently recognized standards
Health Canada recognition of IEC 60601-1-2:2007 - Ed 3.0, a technical standard for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission, has been superseded by recognition of IEC 60601-1-2:2014 - Ed 4.0. Health Canada will continue accepting declarations of conformity, in support of premarket submissions, to IEC 60601-1-2:2007 - Ed 3.0 until December 31, 2018. After this transition period, declarations of conformity to IEC 60601-1-2:2007 - Ed 3.0 will not be accepted.
Join in: how to participate
Participate by mail - Send a letter with your ideas and input to the address in the contact us section below.
Participate by email - Send an email to Standards.Committee@canada.ca with your ideas or comments.
The results of this consultation will be available on this web site.
Who is the focus of this consultation
We will engage with:
- interested public parties
- healthcare professionals
- medical device manufacturers
Key questions for discussion
Health Canada would like you to participate by providing feedback with respect to the proposed changes to TPD'S LORS for medical devices.
Your ideas and inputs are sought regarding:
- the removal of 20 standards.
- the addition of 15 new standards.
- the replacement of previous editions with 12 new editions of currently recognized standards.
The input gathered through this process will be used to update TPD's List of Recognized Standards for Medical Devices.
- Food and Drugs Act
- Medical Device Regulations of Canada
- Therapeutic Products Directorate's (TPD) List of Recognized Standards
Medical Devices Bureau
Therapeutic Products Directorate
11 Holland Ave, Tower A
Address locator: 3005B
Ottawa, ON K1A 0K9
or email: Standards.Committee@hc-sc.gc.ca
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