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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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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.
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Discussions
F
Can an individual apply for an MDEL in Canada, as an establishment?
fialor
Dec 3, 2018
Replies
6
Views
223
Jan 18, 2019
fialor
S
Health Canada's Action Plan on Medical Devices - 2019 milestones
snoopy2017
Dec 21, 2018
Replies
0
Views
125
Dec 21, 2018
snoopy2017
Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?
supadrai
Nov 14, 2018
Replies
7
Views
379
Dec 19, 2018
supadrai
Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)
Leandro
Dec 18, 2018
Replies
0
Views
110
Dec 18, 2018
Leandro
N
Regulatory Responsibilities of an OEM and Private Label manufacturer
natgster
Oct 24, 2018
Replies
3
Views
213
Dec 15, 2018
somashekar
M
Medical Device News
Health Canada Notice of intent: Strengthening the post-market surveillance and risk management
Mark Meer
Nov 5, 2018
Replies
1
Views
541
Dec 10, 2018
Fatima Diab
S
Clinical Studies - Premarket Submission Requirements
snoopy2017
Dec 3, 2018
Replies
1
Views
102
Dec 3, 2018
RA Guy
S
MDEL question - Device Establishment Licence
snoopy2017
Jan 19, 2018
Replies
4
Views
942
Nov 30, 2018
RA Guy
Medical Device News
Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan
Marcelo Antunes
Oct 11, 2018
Replies
2
Views
298
Nov 13, 2018
DannyK
Interesting Read
Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate?
Sidney Vianna
Nov 1, 2018
Replies
0
Views
244
Nov 1, 2018
Sidney Vianna
Medical Device News
Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018
Marcelo Antunes
Oct 17, 2018
Replies
0
Views
179
Oct 17, 2018
Marcelo Antunes
B
Our NB doesn't accept new clients for MDSAP
Berni
Aug 9, 2018
Replies
8
Views
695
Oct 15, 2018
Berni
K
MDSAP scope vs ISO 13485 Scope
krism
Oct 11, 2018
Replies
2
Views
352
Oct 12, 2018
krism
K
Selling products in Canada, distributor? Private Label?
katastic2908
Sep 14, 2018
Replies
2
Views
360
Oct 12, 2018
Edward Reesor
Medical Device News
Health Canada update - Applications for Medical Device Investigational Testing Authorizations
Marcelo Antunes
Oct 1, 2018
Replies
0
Views
137
Oct 1, 2018
Marcelo Antunes
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Forums
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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