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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.
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Canada | Publication | June 23, 2021
On June 16, 2021, Bill C-15, An Act respecting the United Nations Declaration on the Rights of Indigenous Peoples, was passed in the Senate. Bill C-15, first introduced in the House of Commons on December 3, 2020, will be enacted when it receives Royal Assent.
Bill C-15 has some similarities to Bill C-262, a private member’s bill sponsored by former NDP MP Romeo Saganash in 2016. Bill C-262 reached the Senate Committee review stage, but died on the order paper after failing to pass in the Senate. Unlike Bill C-262, Bill C-15 moved expeditiously through the legislative process with limited amendments.
Bill C-15 will set out a framework for the federal government, in consultation and cooperation with Indigenous peoples, to take all measures necessary to ensure federal laws are consistent with the United Nations Declaration on the Rights of Indigenous Peoples (“UNDRIP”). Bill C-15 requires consultation and cooperation with Indigenous peoples and other federal ministers, in order to prepare and implement an action plan to achieve the objectives of UNDRIP. The action plan must be delivered no later than two years after the day on which Bill C-15 comes into force. The Bill also attaches the full text of UNDRIP, including the 46 articles that recognize, among other things, Indigenous self-determination and self-government, as well as rights to language, culture, traditional lands, and resources, and the requirement for the states to consult Indigenous peoples in order to obtain free prior and informed on decisions that affect their rights, communities or territories.
The Act represents another step in reconciliation and the process of aligning existing Canadian law with UNDRIP, and follows in the footsteps of British Columbia’s enactment of the Declaration on the Rights of Indigenous Peoples Act.1
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Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
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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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