Health Canada (HC) postponed the deadline to license Reprocessed Medical Devices by a MDAL (Medical Device Application License) or a MDEL (Medical Device Establishment License) to September 1, 2017.
The new requirements stated in the CMDR (Canadian Medical Devices Regulations) that refer to the validation of the reprocessed devices are:
- obtaining a Medical Device Application License (MDAL) or a Medical Device Establishment License (MDEL);
- compliance to the CMDCAS requirements;
- compliance of the labelling, with removal of the “disposable” symbol;
- records and complaints management;
- recalls and reporting management.
For further information: http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_sud_uu_avis_im-eng.php
