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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
C
CMDR Essential (Safety & Effectiveness) Requirements Checklist?
Replies
8
Views
187
Edward Reesor
E
MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP
Replies
7
Views
352
cmeby
E
Canada Chemicals of Concern - Similiar program for chemicals like the EU
Replies
0
Views
50
Ellison
K
MDSAP scope vs ISO 13485 Scope
Replies
4
Views
532
Edward Reesor
K
Selling products in Canada, distributor? Private Label?
Replies
8
Views
597
DannyK
F
Can an individual apply for an MDEL in Canada, as an establishment?
Replies
6
Views
332
fialor
S
Health Canada's Action Plan on Medical Devices - 2019 milestones
Replies
0
Views
208
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
502
supadrai
Leandro
Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)
Replies
0
Views
160
Leandro
N
Regulatory Responsibilities of an OEM and Private Label manufacturer
Replies
3
Views
290
somashekar
M
Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management
Replies
1
Views
747
Fatima Diab
S
Clinical Studies - Premarket Submission Requirements
Replies
1
Views
142
RA Guy
S
MDEL question - Device Establishment Licence
Replies
4
Views
1,050
RA Guy
Marcelo Antunes
Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan
Replies
2
Views
374
DannyK
Sidney Vianna
Interesting Read Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate?
Replies
0
Views
318
Sidney Vianna
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