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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.
Discussions
S
What does SOR and DORS stand for in the Medical Devices Regulations?
Replies
2
Views
2,641
gordon1944
Leandro
Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)
Replies
3
Views
457
Mikilk
A
Does Class 1 Medical Device need to be certified to MDSAP?
Replies
4
Views
621
RA_QA_Expert
N
Medical Device Misclassified by Health Canada
Replies
2
Views
283
noanalyst
R
Who needs a MDEL (Medical Device Establishment License)?
Replies
6
Views
710
Edward Reesor
J
MDSAP Companion and HC requirements
Replies
4
Views
410
Watchcat
N
How to look up all Class 1 medical devices on sale in Canada
Replies
3
Views
291
noanalyst
K
Interpretation of significant change - material change
Replies
3
Views
464
shimonv
M
Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device
Replies
2
Views
467
RA Guy
L
Medical Device Accessory - Health Canada guidance / definition on what an accessory is
Replies
3
Views
744
RA Guy
M
Medical Device Distribution in Canada - Do we need both MDEL and MDL?
Replies
6
Views
2,064
DannyK
E
MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP
Replies
9
Views
1,295
cscalise
C
CMDR Essential (Safety & Effectiveness) Requirements Checklist?
Replies
9
Views
982
cmeby
E
Canada Chemicals of Concern - Similiar program for chemicals like the EU
Replies
0
Views
270
Ellison
K
MDSAP scope vs ISO 13485 Scope
Replies
4
Views
956
Edward Reesor
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