New Transition Regulations for Health Canada’s Second Interim Order

by | Mar 15, 2021 | FDA, Health Canada, Medical Devices, Quality, Regulatory

Health Canada’s first Interim Order for importation and sale of COVID-19 medical devices issued on March 18, 2020, is set to expire on March 18, 2021.  Health Canada released a second interim order to continue the requirements and the policies granted under the first interim order in light of the continuing COVID-19 woes.

The new interim order which is valid until March 18th, 2022 allows for devices being sold under the first interim order to continue to be made available for use in Canada after the expiry of the first order on March 18th, 2021.1

A transition regulatory plan also has been released by the agency which will ensure that users can continue to have access to the COVID-19 medical devices they need. These proposed transition regulations would take effect when the second interim order ends in March of 2022 and would remain in place for 2 years. During this time, manufacturers, importers, and distributors would have an opportunity to transition from an interim authorization to a regular medical device license or a Medical Device Establishment License (MDEL).

Under the second interim order, the following requirements will be implemented:1

  • Importers and distributors of authorized devices would be given 6 months to apply for and obtain an MDEL.
  • Manufacturers would be required to provide bilingual labeling as applicable.

 

At the end of the second interim order, when the transition regulations are implemented, manufacturers of class I devices will be allowed to continue the import of their products under a temporary class I license for 18 months, and after that they will have to apply for an MDEL or sell through an MDEL holder. For class II, III, and IV devices, active authorizations under the interim order will be granted a medical device license for up to 2 years. Manufacturers will have to submit an MDSAP certificate and demonstrate that they have completed the terms and conditions placed on the product satisfactorily under the interim order. Class III and IV product manufacturers may be required to submit additional evidence such as clinical data, post-market monitoring data, etc.1

While Health Canada has announced its transition plans to smoothly navigate the disturbed regulatory landscape post COVID, it will be interesting to see how FDA and other major regulatory industries help companies to transition from an emergency authorization mode to traditional clearances and approvals. The industry would greatly benefit by implementing a transition period.

Need help in getting your product to market? Call us today at 248-97-4497 or email us at info@emmainternational.com to learn more!


1Health Canada (2020) New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19): Notice to stakeholders retrieved on 03/08/2021 from https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/transition-regulations-interim-order-notice.html

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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