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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
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
204
Today at 1:17 AM
supadrai
N
Regulatory Responsibilities of an OEM and Private Label manufacturer
natgster
Oct 24, 2018
Replies
3
Views
142
Saturday at 3:22 AM
somashekar
F
Can an individual apply for an MDEL in Canada, as an establishment?
fialor
Dec 3, 2018
Replies
5
Views
109
Friday at 10:56 PM
bookish
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
148
Dec 10, 2018
Fatima Diab
B
Clinical Studies - Premarket Submission Requirements
bookish
Dec 3, 2018
Replies
1
Views
64
Dec 3, 2018
RA Guy
S
MDEL question - Device Establishment Licence
snoopy2017
Jan 19, 2018
Replies
4
Views
855
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
228
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
141
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
120
Oct 17, 2018
Marcelo Antunes
B
Our NB doesn't accept new clients for MDSAP
Berni
Aug 9, 2018
Replies
8
Views
589
Oct 15, 2018
Berni
K
MDSAP scope vs ISO 13485 Scope
krism
Oct 11, 2018
Replies
2
Views
247
Oct 12, 2018
krism
K
Selling products in Canada, distributor? Private Label?
katastic2908
Sep 14, 2018
Replies
2
Views
251
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
102
Oct 1, 2018
Marcelo Antunes
Medical Device News
Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices
Marcelo Antunes
Sep 11, 2018
Replies
3
Views
314
Sep 12, 2018
Mark Meer
M
MDSAP Transition - Health Canada Website Notice on Apr 13 2018
Merlynmk20
Sep 11, 2018
Replies
1
Views
246
Sep 12, 2018
RA Guy
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Forums
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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