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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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Other Medical Device Regulations World-Wide
Regulatory systems around the world different from the ones in the above sub-forums.
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A
Brazil: Termination of business relations with BRH – what happens to registrations?
ALenk
Aug 6, 2019
Replies
1
Views
779
Aug 7, 2019
ALenk
A
V
CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing
vardag
Aug 4, 2019
Replies
3
Views
1K
Aug 4, 2019
Watchcat
C
Vietnam - Authorized Medical Device Representative Change
celticfrosting
Mar 1, 2018
2
Replies
10
Views
4K
Aug 2, 2019
David Vo
L
Staying up to date on Regulations
lizVR
Jul 30, 2019
Replies
8
Views
1K
Aug 1, 2019
Ron Rompen
Informational
MDSAP Audit Findings - Document change orders
XRAY_3121
Apr 17, 2019
2
Replies
12
Views
3K
Jul 23, 2019
Ronen E
M
Medical Device Registration in Venezuela
mjain
May 23, 2012
Replies
6
Views
7K
Jul 16, 2019
biokeithmed
B
J
Pre-clinical Studies for RUO Product
Jer Chen
Jul 9, 2019
Replies
1
Views
905
Jul 9, 2019
Ronen E
Y
Can there be multiple Brazil Registration Holder (BRH) for same model ?
youuu
Aug 13, 2013
Replies
3
Views
4K
Jul 3, 2019
Cindy
C
C
What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia?
CrystalRose
Jul 3, 2019
Replies
0
Views
782
Jul 3, 2019
CrystalRose
C
Dispute with Competent Authority
JoCam
Jul 2, 2019
Replies
3
Views
817
Jul 2, 2019
shimonv
J
Where I can get a copy of either the 3rd or 4th edition of UL544?
Jack Goldberg
Jun 26, 2019
Replies
7
Views
1K
Jun 28, 2019
Jack Goldberg
J
S
Adverse Event and Serious Adverse Event Reporting - Korea
sreenu927
May 10, 2018
Replies
4
Views
4K
Jun 25, 2019
Enrico Greco
E
M
Is it compulsory to update the obsolete GMDN codes in ARTG?
MEa
Jun 17, 2019
Replies
4
Views
2K
Jun 19, 2019
MEa
M
R
Clinical validation/investigation in Egypt - Medical Devices sevices that are not marked yet
RA Lille
Dec 12, 2018
Replies
4
Views
1K
Jun 19, 2019
SKM.Sunil
P
Can someone share their experience with KFDA Inspection ?
phloQS
Jul 31, 2012
2
3
4
Replies
30
Views
15K
Jun 17, 2019
Wolf.K
W
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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