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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
A
Does Class 1 Medical Device need to be certified to MDSAP?
Replies
4
Views
284
RA_QA_Expert
R
Who needs a MDEL (Medical Device Establishment License)?
Replies
6
Views
253
Edward Reesor
J
MDSAP Companion and HC requirements
Replies
4
Views
198
Watchcat
K
Interpretation of significant change - material change
Replies
3
Views
309
shimonv
M
Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device
Replies
2
Views
328
RA Guy
L
Medical Device Accessory - Health Canada guidance / definition on what an accessory is
Replies
3
Views
484
RA Guy
M
Medical Device Distribution in Canada - Do we need both MDEL and MDL?
Replies
6
Views
1,888
DannyK
E
MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP
Replies
9
Views
1,014
cscalise
C
CMDR Essential (Safety & Effectiveness) Requirements Checklist?
Replies
9
Views
733
cmeby
E
Canada Chemicals of Concern - Similiar program for chemicals like the EU
Replies
0
Views
222
Ellison
K
MDSAP scope vs ISO 13485 Scope
Replies
4
Views
847
Edward Reesor
K
Selling products in Canada, distributor? Private Label?
Replies
8
Views
1,055
DannyK
F
Can an individual apply for an MDEL in Canada, as an establishment?
Replies
6
Views
595
fialor
S
Health Canada's Action Plan on Medical Devices - 2019 milestones
Replies
0
Views
335
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
692
supadrai
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