Hello Anon,
The process for a Class II single-use and reusable device for Health Canada is essentially the same for the documentation provided. The biggest difference may be content and review of the Instructions for Use (IFU) which includes the instructions, methods, and materials for re-processing the medical device. In addition, you might have a request for the re-processing validation, e.g. cleaning, disinfecting, sterilisation, though Class II application to Health Canada are fairly straight forward. It would really be a review of the IFU which includes the re-processing instructions. Review the links to guidance already provided, should find the information needed there.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Apr-2023 20:19
From: Anne LeBlanc
Subject: Registering Non Sterile Reusable Device in Canada
Hi Anon
Here's a basic guidance for devices in classes II, III, and IV, with links to some more detailed guidance documents:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html
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Anne LeBlanc
United States
Original Message:
Sent: 25-Apr-2023 13:12
From: Karen Zhou
Subject: Registering Non Sterile Reusable Device in Canada
Hello Anon,
I came across this document. I hope it helps.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-information-manufacturers-sterilization-reusable-medical-devices.html
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Karen Zhou
Original Message:
Sent: 25-Apr-2023 09:56
From: Anonymous Member
Subject: Registering Non Sterile Reusable Device in Canada
This message was posted by a user wishing to remain anonymous
Good morning,
I've looked on Health Canada and cannot find any guidance on what my team may need to register a nonsterile, reusable device in Canada. Can anyone provide any help?
We've registered other nonsterile and sterile Class II products, but they are not reusable. Adding a reusable product to Canada would be new to us.
Thanks in advance.