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: