On April 19, 2010, Health Canada announced a list of proposed changes to recognized standards for medical device. This announcement started a 60-day comment period. Submit comments to Health Canada no later than June 18, 2010 to an address included in the proposal.
The proposed changes
- Add 22 new standards
- Recognize new versions of 92 currently recognized standards
- Delete 31 standards
Included in the new versions of currently recognized standards are:
ISO 14971:2007 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971-07 Medical devices – Application of risk management to medical devices
The list does not propose any changes for ISO 13485.
The list of proposed changes is at
The current List of Recognized Standards is posted at
A Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations is posted at