Regulatory Focus™ > News Articles > New Health Canada Rules Cover Single-Use Reprocessed Devices

New Health Canada Rules Cover Single-Use Reprocessed Devices

Posted 17 February 2015 | By Stewart Eisenhart

New Health Canada Rules Cover Single-Use Reprocessed Devices

Content provided by Emergo, a medical deviceregulatory affairs and quality assurance consulting firm with offices worldwide.

Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to follow Canadian Medical Device Regulations (CMDR) by 1 September 2016.

According to Canadian medical technology trade group MEDEC, the new  requirement will apply to all commercially reprocessed single-use devices, but Health Canada will leave in place provincial- and territorial-level oversight of device reprocessing, which is carried out at hospitals.

CMDR compliance includes Medical Device Licensing, quality system implementation and management, labeling, post market vigilance and other requirements that all other medical devices licensed for sale in Canada must meet. MEDEC touts Health Canada’s decision to fully regulate reprocessed devices as a positive step for public health, noting that a significant percentage of single-use devices in hospitals across the country are now reprocessed by third-party firms with no obligation to comply with  CMDR.

 

Original Post: Emergo Blog

Related Post:  New Guidance from Health Canada on Medical Device License Renewal


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