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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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Canada Medical Device Regulations
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
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Discussions
COVID 19 Exception and MDSAP
Ed Panek
Jan 14, 2021
Replies
4
Views
169
Yesterday at 10:24 PM
DannyK
M
Canadian regulation gap assessment
MDRexpert
Sep 3, 2020
Replies
7
Views
655
Dec 11, 2020
burche
M
Is it Necessary to Use Health Canada Form when Reporting?
Mark Meer
Nov 27, 2020
Replies
1
Views
258
Dec 3, 2020
RA Guy
R
Class 1 Convenience kits for home teeth impression, NOT smile direct or other for alignment purposes
Robyn W
Oct 30, 2020
Replies
0
Views
285
Oct 30, 2020
Robyn W
R
MDEL and company affiliate
Robyn W
Oct 30, 2020
Replies
0
Views
188
Oct 30, 2020
Robyn W
D
GMDN code update - Canada - Do you know if there is guidance?
danir30
Sep 30, 2020
Replies
0
Views
448
Sep 30, 2020
danir30
M
Subcontracting a repair of Medical Devices
MDRepair Canada
Sep 23, 2020
Replies
0
Views
275
Sep 23, 2020
MDRepair Canada
D
Where to find Guidance Class II Amendment
danir30
Sep 2, 2020
Replies
1
Views
447
Sep 19, 2020
v9991
D
Amendment Class II - Please confirm if the submission is by email (Canada) - Help
danir30
Sep 17, 2020
Replies
0
Views
275
Sep 17, 2020
danir30
R
Product Recall - medical devices in the hospital warehouse
RA_QA_Expert
Aug 27, 2020
Replies
2
Views
416
Sep 2, 2020
levatorsuperioris
S
Work performed in Canada on US patients using US device
SSchoepel
Aug 26, 2020
Replies
1
Views
340
Aug 27, 2020
shimonv
R
Exporting to Canada and MDSAP
Raccar
Aug 5, 2020
Replies
7
Views
723
Aug 20, 2020
Edward Reesor
Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both?
gunnyshore
Aug 18, 2020
Replies
3
Views
368
Aug 19, 2020
DannyK
D
Adding a Class I to a sample box
dr1vn
Jul 21, 2020
Replies
5
Views
505
Jul 28, 2020
dr1vn
D
Class 3 Device - Change of supplier of material
DH1981
Jul 16, 2020
Replies
6
Views
691
Jul 17, 2020
RA Guy
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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