Health Canada Interim Orders

by Nikita Angane | Dec 4, 2020 | COVID-19, FDA, Health Canada, Medical Devices, Quality, Regulatory

Health Canada released a notice for the stakeholders of the medical device and drug industry to help them understand the tenure of the interim orders released during the pandemic.¹

Since March 2020, Health Canada released five interim orders each of which streamlines and adds some flexibility to the regulatory oversight provided by the agency. The following interim orders were released in order to meet the supply shortages and the increased demands for COVID essential products:¹

Interim order – importation and sale of medical devices
Interim order – permitting exceptional importation of key products
Interim order – clinical trials for medical devices and drugs
Interim order – importation, sale, and advertising of drugs
Interim order – prevention and alleviation of drug shortages

As per the release of this notice, Health Canada intends to maintain the governance of these interim orders until at least the fall of 2021. The agency also intends to bring some amendments to their regulatory system that will allow for the current flexibilities to continue post Fall of 2021.¹

As its next steps, Health Canada plans to consult with the industry stakeholders and other authorities on the proposed amended regulations. This step taken by Health Canada is crucial for manufacturers and other companies who pivoted their operations in support of the supply shortages created by the pandemic. This rule will allow for newly formed companies to continue selling their products at least until the Fall of 2021 and post that with appropriate regulatory requirements.¹

It will be interesting to see how other countries across the globe develop a plan to help the medical device and the drug industry transition out of the interim policies put in place during COVID. At EMMA International we are closely monitoring the ever-evolving regulatory landscape and will keep you updated on its impact on the industry.

Call us today at +1 248-987-4497 or email us at info@emmainternational.com to know more about how this rule impacts you.

¹Health Canada (Nov 2020) Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders retrieved on 12/03/2020 from https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/ensuring-predictability-interim-orders-notice.html

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.