Canada Medical Device Regulations

This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
Discussions
K
Interpretation of significant change - material change
Replies
3
Views
207
shimonv
M
Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device
Replies
2
Views
239
RA Guy
L
Medical Device Accessory - Health Canada guidance / definition on what an accessory is
Replies
3
Views
350
RA Guy
M
Medical Device Distribution in Canada - Do we need both MDEL and MDL?
Replies
6
Views
1,770
DannyK
E
MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP
Replies
9
Views
842
cscalise
C
CMDR Essential (Safety & Effectiveness) Requirements Checklist?
Replies
9
Views
566
cmeby
E
Canada Chemicals of Concern - Similiar program for chemicals like the EU
Replies
0
Views
197
Ellison
K
MDSAP scope vs ISO 13485 Scope
Replies
4
Views
779
Edward Reesor
K
Selling products in Canada, distributor? Private Label?
Replies
8
Views
961
DannyK
F
Can an individual apply for an MDEL in Canada, as an establishment?
Replies
6
Views
550
fialor
S
Health Canada's Action Plan on Medical Devices - 2019 milestones
Replies
0
Views
314
snoopy2017
supadrai
Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?
Replies
7
Views
675
supadrai
Leandro
Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)
Replies
0
Views
225
Leandro
N
Regulatory Responsibilities of an OEM and Private Label manufacturer
Replies
3
Views
417
somashekar
M
Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management
Replies
1
Views
928
Fatima Diab
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