For the attention of SCC-accredited certification bodies certifying organizations under the CMDCAS program,
Although many medical devices are labeled as “single-use”, it has been common practise for hospitals to re-process (i.e. cleaned, sterilised and disinfected) these devices to save on costs. Recently, hospitals have begun outsourcing this re-processing to private companies. Health Canada, through its development of on new patient safety legislation, has determined that it has the authority under the existing Food and Drugs Act and Medical Devices Regulations to now require these re-processing companies to meet appropriate standards for safety, effectiveness and labelling. Essentially, these companies will now require the same certification under the CMDCAS program as if they were medical device manufacturers. Please note that this does not apply to hospital on-site re-processing.
Health Canada will phase in these new requirements over the next 18 months, which will involve discussions with members of the re-processing industry to help them bring their activities into compliance.
By September 1, 2016, all commercially reprocessed devices are expected to be in compliance with the Regulations, whether they are reprocessed domestically or outside Canada. Non-compliant devices and activities will continue to be subject to risk-based compliance enforcement.
Health Canada will be announcing these new requirements on Friday, March 13th, 2015, and SCC wanted its accredited certification bodies to be aware of these new requirements ahead of time, in case they begin to receive enquiries from re-processing companies.
If you have any questions, please contact Cynthia Milito, Director, Accreditation Services at firstname.lastname@example.org or +1 613 238 3222 ext. 489.