Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices

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#1
#1
Does anyone know what Health Canada's policy is on accepting foreign clinical performance data for near patient Class III IVDD?

I can't seem to find this in any guidance document. Any help would be very much appreciated.
 
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#3
#3
Hi,

There is a "Draft Guidance Document Preparation of Summary Technical Document (STED)-based Class III and IV Premarket in vitro diagnostic device licence applications and amendments" http://www.hc-sc.gc.ca/dhp-mps/cons...im_ld_donnees_ciii_civ_ivdd_sted-eng.php#a392

which states that "The IVDD should be tested against a reference standard, method, or test, having a true clinical status, if known. If the reference is a commercial assay, it must have a valid Canadian licence. The complete name(s) of the device(s) and the licence number(s) should be provided. If there is no Canadian licensed test, you are encouraged to contact the Medical Devices Bureau for further guidance." This guidance supplies detailed information of the required format of the clinical performance data.

Contact info of Medical Devices Bureau for further info:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
2934 Baseline Road
Address locator: 3403A
Ottawa, Ontario

Phone: 613-954-0297
Fax: 613-957-9969
E-mail: [email protected]
 
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