Print | Need Larger Text? | Share

Consultation on the Release of Draft Guidance for the Interpretation of Significant Change of a Medical Device

The Medical Devices Regulations (Regulations) set out the requirements governing the sale, importation and advertisement of medical devices. The goal of the Regulations is to ensure that medical devices offered for sale in Canada are safe and effective and meet quality standards. Class II, III and IV medical devices sold in Canada are required to be licensed under section 26 of the Regulations. Section 34 of the Regulations describes five instances when a manufacturer is obliged to apply for an amended medical device licence. One of those instances is when a "significant change" is proposed to a Class III or IV device.

This guidance document elaborates upon the definition of "significant change" in the Regulations, in order to assist manufacturers in determining whether a change proposed to a class III or IV medical device requires the submission to Health Canada of a licence amendment application, prior to introducing the device to the market.

Comments on this draft guidance document should be submitted, within 60 calendar days of the date of this notice.

How to Get Involved

This consultation is open for comment starting July 14, 2009 until September 15, 2009. Please select and read through the link below titled "consultation document". Once read, please submit your comments via email, fax or by mail to:

DED_Manager@hc-sc.gc.ca

Manager
Device Evaluation Division, Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Main Building, Room 1605
150 Tunney's Pasture Driveway
Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Phone: (613) 954-0298
Fax: (613) 957-9969

Consultation Document: To obtain a copy of the draft guidance document that was consulted upon, please contact the Device Evaluation Division, Medical Devices Bureau.

Interested parties are encouraged to provide comments and suggestions by September 15, 2009.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact DED_Manager@hc-sc.gc.ca