Dec 2, 2020
Health Canada (HC) announced plans to leave several Interim Orders relating to the COVID-19 pandemic in place until fall of next year.
Beginning in March 2020, the regulator established five Interim Orders, three of which pertain to medical devices, as part of its push to expedite the approval of new healthcare technologies and to ensure the adequate supply of needed treatments. In order to maintain a stable regulatory environment for medical device and drug manufacturers to access the market, Health Canada is now committing to extending all of the IOs through fall 2021 at the earliest. By this point, HC plans to have introduced regulatory amendments to preserve the desired balance of flexibility and regulatory oversight beyond this time frame.
HC’s next steps given in the announcement will be to hold public consultations with stakeholders on the content of the proposed regulatory amendments. The web page will be updated with links to such consultations as they occur. An email contact is given for interested parties to make further inquiries about the process.
The regulator intends to streamline regulatory submissions with the Regulatory Enrolment Program, using an online platform that utilizes extensible markup language (XML) for automated metadata generation.
The government body has published two Interim Orders along with a series of notices and guidance documents aimed at promoting the supply of necessary medical devices.
Electronic submissions for some medical device clinical trial information now accepted by Canadian regulator
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