By Stewart Eisenhart, Emergo Group
Health Canada has announced changes to its list of recognized list of medical device standards used to demonstrate safety, effectiveness and labeling requirements of the Canadian Medical Devices Regulations in order to foster more efficient device reviews.
The changes to the Therapeutic Products Directorate’s List of Recognized Standards for medical devices have specifically been altered as follows:
- 28 new standards will be added to the List
- 10 new editions of currently recognized standards will replace previous editions
- One standard will be deleted from the List
- Two standards will be superseded
These changes are part of Health Canada’s ongoing effort to ensure standards it requires licensed medical device manufacturers to follow are up to date.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.