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New rules for MDEL holders: Health Canada’s terms and conditions authority
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
Canada | Publication | March 19, 2020 - 9 PM ET
In response to the mounting as COVID-19 (coronavirus) crisis, the CSA announced it will provide blanket relief from certain regulatory filings required to be filed on or before June 1, 2020.
The proposed relief will provide a blanket 45-day extension from existing deadlines for periodic filings required to be made by issuers on or before June 1, 2020, including annual financial statements, MD&A and annual information forms. Further details of the relief will be published shortly.
The extension applies to all issuers. For those with a December 31 year-end, the extensions are as follows:
Original Deadline | New deadline | |
---|---|---|
Annual filing deadline (year-end financials, MD&A and AIF) | March 30 | May 14 |
Q1 filing deadline | May 15 | June 29 |
Original Deadline | New deadline | |
---|---|---|
Annual filing deadline (year-end financials, MD&A and AIF) | April 29 | June 15 |
Q1 filing deadline | June 1 | July 14 |
The requirement to file a management cease-trade order, announced earlier this week, no longer applies to issuers who will miss a deadline as a result of the coronavirus, provided they comply with the soon-to-be-announced relief conditions.
The relief will allow issuers to focus on critical business decisions surrounding the virus.
In addition, the CSA has indicated it will soon be issuing guidance on annual general meetings in light of issuers considering virtual meetings to mitigate the risk of transmission of the coronavirus.
We will keep you posted as further details become available.
Publication
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
Publication
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As you prepare for your next AGM, stay up-to-date on key developments in Canadian corporate and securities legislation, corporate governance guidance and institutional shareholder proxy voting guidelines that may impact the management information circular for your 2025 annual shareholder meeting and your 2025 annual disclosure filings.
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