Medical devices: Working with partners

Our objective was to make it easier for medical device manufacturers and other firms subject to Canada’s medical device regulations to find and understand the information they need to comply with regulatory requirements.

Date

2020

Partner department

• Health Canada (HC)

Why this work matters

• Analytics show that more than half of the visits to pages about medical devices are to those that provide information specific to the medical device industry

Task scenarios tested and improved

• Your team has been working on a knee prosthesis that you would like to bring to market. You're submitting a Class III medical device licence application. Will you need to submit a declaration of conformity as part of your application?
• Your United States-based business imports hydraulic stretchers (a Class I medical device) from Europe and sells them online to health care facilities in the U.S. and Canada. Do you need a Medical Device Establishment Licence (MDEL) from Health Canada?
• Your company manufactures infrared lamps. Can you determine what class of medical device licence is required?
• Starting in 2019, a new process was introduced for Quality Management System certification for medical devices. The advantage for manufacturers is that quality auditing will now be recognized internationally. In how many nations is the certification now recognized?
• Your company manufactures sleep apnea equipment. You received your medical device licence September 1, 2019. What do you need to do to renew your medical device licence for 2020?
• There was recently a problem with one of the medical devices your company sells in Canada. Under which of the following circumstances is your company required to report the incident to Health Canada?
• Your distribution company delivered temperature-sensitive medical devices to hospitals. You later discover that one of the freezers at your facility was above the required temperature for storing the product. Do you need to initiate a recall?
• Your competitor produces a light therapy product similar to yours. You have reason to believe that the competitor's product label regarding the amount of light it emits is incorrect. Can you show me the form you would use to report your concerns to Health Canada?