Compliance deadline for Commercially Reprocessed Medical Device to be extended
According to Health Canada, the Canadian medical device market regulator is planning to extend the deadline for commercially reprocessed devices to obtain Medical Device and Medical Device Establishment Licenses so as to meet market authorization requirements.
For companies that engages in reprocessing and distribution of single-use devices regardless in Canada or abroad, the deadline to meet the same Health Canada licensing and registration requirements currently in place for new devices according to the Canadian Medical Devices Regulations (CMDR) is September 1, 2017. There are no plans in extending these requirements to devices that are reprocessed on site at hospitals thus far as these products continues 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
•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.
The initial deadline for reprocessed devices was originally set for September 1,2016, but the date was extended to 2017 as regulators wanted to grant more time for manufacturers and reprocessors to meet CMDR requirements.