Health Canada Extends Compliance Deadline for Commercially Reprocessed Medical Devices
Health Canada, the Canadian medical device market regulator, plans to extend its deadline for commercially reprocessed devices to obtain Medical Device and Medical Device Establishment Licenses and meet market authorization requirements, according to the agency.
Companies engaged in reprocessing and distribution of single-use devices—whether in Canada or abroad—now have until September 1, 2017 to meet the same Health Canada licensing and registration requirements currently in place for new devices according to the Canadian Medical Devices Regulations (CMDR). However, Health Canada does not plan to extend these requirements to devices that are reprocessed on site at hospitals—these products will continue to be overseen by provincial and territorial authorities.
Among the CMDR requirements reprocessed medical devices will need to meet in Canada are:
- Obtaining a Medical Device License (MDL) or Medical Device Establishment License (MDEL)
- Quality management system compliance
- Device labeling
- Investigations and complaint handling
- Conducting recalls and incident reporting
Regarding labeling, reprocessed device labels should clearly identify reprocessors as their manufacturers as well as provide instructions for safe reuse. Any single-use symbols should also be removed from reprocessed device labels.
Health Canada compliance deadlines for reprocessed devices had originally been set for September 1, 2016, but the regulator opted to extend those deadlines to 2017 to grant more time for manufacturers and reprocessors to meet CMDR requirements.