+39 06 5782665
contact@donawa.com
Italy - UK - USA

Canada updates standards recognition list and PMS rules

  • Posted by: inetika
  • Category: GLOBAL NEWS

Health Canada has recently updated its list of recognised standards to include 14 new standards, the replacement of 29 standards with newer editions, and the removal of three standards. Stakeholders have until 16 March 2021 to comment on the revised list.

In addition, Health Canada is reminding companies that its rules on post market surveillance (PMS) are changing later in 2021, with the most significant change being the introduction of the need for summary reports to be submitted at regular intervals for all but Class I devices.

Four guidance documents are being prepared, as follows:
1. incident reporting for medical devices
2. foreign risk notification for medical devices
3. summary reports and issue-related analyses of safety and effectiveness for medical devices
4. guide to new authorities on the amendments to include power to require assessments and power to require tests and studies

This website uses cookies and asks your personal data to enhance your browsing experience.