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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
M
Who needs a MDEL? How to buy and sell medical devices on my own
Replies
7
Views
140
Michel-a
JoCam
MDL in Canada without Canadian Electrical Testing
Replies
0
Views
103
JoCam
K
Selling Medical Devices in Canada - Distributor? Private Label?
2
Replies
10
Views
1,677
atifd
A
Does Class 1 Medical Device need to be certified to MDSAP?
Replies
5
Views
906
myusoffice
S
What does SOR and DORS stand for in the Medical Devices Regulations?
Replies
2
Views
2,881
gordon1944
Leandro
Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)
Replies
3
Views
571
Mikilk
N
Medical Device Misclassified by Health Canada
Replies
2
Views
395
noanalyst
R
Who needs a MDEL (Medical Device Establishment License)?
Replies
6
Views
1,071
Edward Reesor
J
MDSAP Companion and HC requirements
Replies
4
Views
571
Watchcat
N
How to look up all Class 1 medical devices on sale in Canada
Replies
3
Views
412
noanalyst
K
Interpretation of significant change - material change
Replies
3
Views
555
shimonv
M
Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device
Replies
2
Views
545
RA Guy
L
Medical Device Accessory - Health Canada guidance / definition on what an accessory is
Replies
3
Views
926
RA Guy
M
Medical Device Distribution in Canada - Do we need both MDEL and MDL?
Replies
6
Views
2,207
DannyK
E
MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP
Replies
9
Views
1,415
cscalise
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