Health Canada, the USFDA and their UK and European equivalents are taking steps to streamline approval and change notification processes for medical devices (especially masks and ventilators), COVID-19 diagnostic test kits (of which there are dozens of brands and approaches), and drugs for the prevention, diagnosis and treatment of COVID-19.

On March 18, 2020, the Minister of Health issued an Interim Order under section 30(1) (presumably sub-subsection (j)) of the Food and Drugs Act setting out that the device licensing and site licensing provisions of the Medical Device Regulations do not apply to necessary devices if certain procedures are followed, including that a minimized application is made, and the Minister (Health Canada) adds the device to a list called the “List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic” maintained by Health Canada (and which can be found at https://tinyurl.com/suh3fq7).

Diagnostic test kits are normally medical devices under Canadian law.

In essence, the Order permits rapid approval of COVID-19 related devices based mainly on prior approval by a “foreign regulatory authority”, which is very widely defined.  If added to the list, foreign-approved items may be imported with significantly fewer restrictions.  Some additional steps are required for risk class III and IV devices, which would include ventilators.  The Order also provides for the rapid approval of new uses, related to COVID-19, for already approved devices.

For advice on this and all regulatory matters, contact DWW partners Gord Jepson at gjepson@dww.com or Gervas Wall at gwall@dww.com.

Summary By: Gordon Jepson

E-TIPS® ISSUE

20 03 24

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