Consultation - Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices – May 2016

May 3, 2016
Our file number: 16-104549-842

Health Canada is pleased to announce proposed changes to the Therapeutic Products Directorate's (TPD) List of Recognized Standards for medical devices.

The proposed changes consist of:

1. Seven (7) new standards to be added;
2. Two (2) new editions of currently recognized standards added alongside existing version, with a transition period of three years from the standard's publication date.
   These standards are:
   1. IEC 61010-2-101:2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
   2. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
3. Nine (9) new editions of currently recognized standards to replace previous editions;
4. Two (2) standards to be removed.

How to Get Involved

This consultation is open for comment starting May 3, 2016 until July 2, 2016.  Please select and read through the link below titled "consultation document".  Once read, please submit your comments via email, facsimile or by mail to:

Standards.Committee@hc-sc.gc.ca

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
2934 Baseline Road, Tower B
Address Locator 3403A
Ottawa, Ontario
K1A 0K9

Telephone: (613) 954-0297
Facsimile: (613) 957-9969

Consultation Document

Interested parties are encouraged to provide comments and suggestions by July 2, 2016.

Reporting to Canadians

Health Canada will make the results of this consultation available on this website.
If you have any questions, contact the Device Evaluation Division, Medical Devices Bureau.