Consultation on proposed changes to the Medical Devices Directorate’s Draft Guidance Document - List of Recognized Standards for Medical Devices - Closed Consultation

The goal of the consultation was to solicit feedback from stakeholders in regards to an update to the List of Recognized Standards for Medical Devices.

Who was the focus of this consultation

We engaged with:

• Interested public parties
• Healthcare professionals
• Medical device manufacturers

Goals of the consultation

The consultation aimed to notify stakeholders of the proposed changes to the List of Recognized Standards for Medical Devices and solicit feedback to ensure that stakeholders had no objections with the proposed modifications.

Key questions for discussion

Ideas and inputs were sought regarding:

• The removal of 3 standards
• The addition of 14 new standards; and
• The replacement of previous editions with 29 new editions of currently recognized standards

The input that was gathered through this process will be used to update MDD's List of Recognized Standards for Medical Devices.

What we heard

There were editorial changes suggested, which will be adopted as part of the final version of the List of Recognized Standards. Additionally, new standards and new versions of standards were proposed. The proposals have been documented such that they can be considered for future revisions of the List of Recognize Standards.

Contact us

Medical Devices Directorate
Health Canada
11 Holland Ave, Tower A
Address locator: 3005B
Ottawa, ON K1A 0K9

Fax: 613-957-9969
Email: standards.committee@canada.ca