On 15 June 2019 the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) were pre-published.(1) These proposed changes were made in accordance with Vanessa's Law (for further details please see "Update on Vanessa's Law").
The proposed regulations would implement changes to the Food and Drug Regulations and Medical Devices Regulations and (among other things) would:
- establish a regulatory framework to require assessments, tests and studies of medical devices;
- support post-market safety through imposing notification requirements for foreign incidents which must be reported within 72 hours for medical devices; and
- require medical device licence holders to prepare annual summary reports and supporting information relating to adverse effects, reported programmes, incidents and risks similar to a provision in the Food and Drug Regulations.
Comments are due by 26 August 2019.
On 29 May 2019 Health Canada published amendments to the Management of Applications for Medical Device Licences Guidance Document, which was rewritten, including to update and conform to good guidance practices.
Endnotes
(1) The news release is available here
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