Due to the Covid-19 outbreak early this year, the Minister of Health took swift action in March through the introduction of Interim Orders for medical devices. The order’s aim was to safeguard public health by ensuring the availability of adequate medical device supplies. The interim measures relaxed the importation rules allowing for accelerated authorization, access and sale of products that met Health Canada’s definition of “designated medical devices”; however, that may have not fully met regulatory requirements to be imported and sold. These products included face masks, gloves, isolation gowns, and specific types of thermometers, ventilators and respirators.
Proposed Regulatory Amendments to Interim orders for Medical Devices
The interim orders for medical devices were set to expire on March 18, 2021 however Health Canada proposed regulatory amendments in November through the introduction of a second interim order. The new proposed order will carry over many of the flexibilities available under the current interim orders until at least Fall of 2021. After the second interim order ends, the proposed Transition Regulations will come into effect and is expected to remain in place for two years.
The two-year transition period will allow manufacturers, importers and distributors the opportunity to change over from the interim authorization to a regular Medical Device License [MDL] or a Medical Device Establishment License [MDEL].
Health Canada is currently consulting industry and key stakeholders on the proposed transition regulations.