Health Canada Amended Certain Regulations Concerning Medical Devices

Therapeutic Goods Medical Devices

On 11 August 2021, HSA amended the Food and Drug Regulations and Medical Devices Regulations concerning shortages of Medical Devices and Medicinal Drugs in Canada, the amendment was published in the Canada Gazette, Part II on 1 September 2021.

These new regulations extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help track, prevent and mitigate shortages of key health products in Canada, including drugs and medical devices.

Coming into force on 27 November 2021, are provisions that:

  • Prohibit the distribution of drugs intended for the Canadian market outside of Canada that could cause or worsen a shortage,
  • Allow the Minister to compel information in respect of drug shortages.

Coming into force on 1 March 2022, are provisions concerning the:

  • Exceptional importation and sale of drugs, medical devices,
  • Mandatory reporting of shortages of specified medical devices and the power to compel information on medical device shortages,
  • Extension of licensing flexibilities for some drug-based hand sanitizers.

Contact RegASK to know more about medical devices regulation changes. Get in touch with RegASK’s experts.


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