Hello,
Further to the information already provided please note that the term "sell" in the Canadian Food and Drugs Act includes "giving" and "loaning" (so no money needs to transfer hands". It is defined as follows:
sell includes
-
(a) offer for sale, expose for sale or have in possession for sale - or distribute to one or more persons, whether or not the distribution is made for consideration, and
-
(b) lease, offer for lease, expose for lease or have in possession for lease; (vente)
With regards to what clinical evidence needs to be provided in support of Medical Device Licence application, for Class III and IV IVDDs, please refer to these guidance documents:
Class 3, in vitro diagnostic devices (IVD), new and amendment applications - Canada.ca (specifically Section 4)
Class 4, in vitro diagnostic devices (IVD), new and amendment applications - Canada.ca (specifically Section 4)
If your IVDD is for the detection of HIV, then there are specific guidances that HC has published:
Guidance Document - Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing - Canada.ca
Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be used in the Laboratory - Canada.ca
Please note that since HC doesn't have a lot of IVDD guidance documents for specific types of IVDDs, if FDA has published such a guidance, HC will follow that.
There is also a general web page with guidance on clinical data required for medical devices in general (not IVDD specific) that can be found here.
Guidance on clinical evidence requirements for medical devices: Overview - Canada.ca
Health Canada does not expect the clinical trials to be conducted in Canada, however, if they are conducted outside of Canada, then a rationale for the demographics of the subjects included in the trial are representative of the Canadian population should be given. Obviously, for some types of IVDDs, demographics are not an issue.
If your clinical trial is includes a comparison to another IVDD for performance, ensure that the comparator is licensed in Canada or HC will not accept this data on its own. However, It can be used as additional supporting information. If the IVDD is a novel assay and there are no others like it in Canada (or anywhere), then a comparison to the "gold standard" methodology can be used instead.
Hope this helps,
Shirley
------------------------------
Shirley Furesz RAC
Director, Regulatory Affairs Medical Devices
Innomar Strategies Inc.
Oakville Canada
+1 5192426476
sfuresz@tpireg.com------------------------------
Original Message:
Sent: 06-Jul-2023 07:40
From: Anonymous Member
Subject: Clinical studies requirement for IVDD in Health Canada
This message was posted by a user wishing to remain anonymous
Hello Anon
That section of the regulation is worded oddly. You can retain ownership of a device under investigation. If you're selling it, the buyer must be a qualified investigator.
The most applicable guidance documents are probably
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
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cover-letter-application-investigational-vitro-diagnostics-devices.html
Original Message:
Sent: 28-Jun-2023 22:27
From: Anonymous Member
Subject: Clinical studies requirement for IVDD in Health Canada
This message was posted by a user wishing to remain anonymous
Hello all,
I am looking to get clarity on clinical evidence/studies requirements for applying a MDL in HC. Are there any guidance that talks about this? what are the steps, can clinical studies be performed outside Canada, if so where is this stated? If not what needs to be done?
Also, going through the regulation SOR 98-282, I was confused on section 80 (2) that talks about "A manufacture or importer of a Class II, III and IV MD may sell the device to a qualified investigator,,,," what does sell the device pertain too? Does that mean we have to sell to a qualified investigator to perform testing?
Thanks,