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
http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/md_stand_im_norm_prop_lst-eng.php
The current List of Recognized Standards is posted at
http://www.hc-sc.gc.ca/dhp-mps/mdim/standards-normes/md_rec_stand_im_norm_lst_2-eng.php
A Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations is posted at
http://www.hc-sc.gc.ca/dhp-mps/md-im/applicdemande/guideld/md_gd_standards_im_ld_normes-eng.php