Other Medical Device Regulations World-Wide

Regulatory systems around the world different from the ones in the above sub-forums.

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FAQs
Marc
Medical Device Registration Process in Brazil - Anvisa (Part 3)
3 4 5 6 7 8 9 10 11 12
Replies
113
Views
17,790
Marcelo Antunes
R
  • Sticky
Medical Device Approval in Brazil - Understanding INMETRO and ANVISA
4 5 6 7 8 9 10 11 12 13
Replies
120
Views
28,525
Marcelo Antunes
Marcelo Antunes
  • Sticky
Guidance for Medical Device Registration in Med Dev Regulations World-Wide
2 3
Replies
22
Views
8,429
Marcelo Antunes
Marc
Medical Equipment Inmetro Certification Process in Brazil - Part 2
Replies
3
Views
3,369
Marcelo Antunes
Marcelo Antunes
Medical Equipment Inmetro Certification Process in Brazil - Part 1
2 3 4 5
Replies
45
Views
18,997
Marc
Marc
Medical Device Registration Process in Brazil - Anvisa (Part 2)
2 3 4 5 6 7 8
Replies
71
Views
16,829
Marc
Marcelo Antunes
  • Sticky
Future revision of ANVISA RDC 59 - Brazilian GMP
2
Replies
14
Views
8,410
Marcelo Antunes
Marcelo Antunes
Medical Device Registration Process in Brazil - Anvisa (Part 1)
22 23 24 25 26 27 28 29 30 31
Replies
300
Views
101,477
Marcelo Antunes
Discussions
J
Saudi Arabia - Insistence on a signed NB audit report (When one does not exist)
Replies
8
Views
732
Al Rosen
R
Clinical validation/investigation in Egypt - Medical Devices evices that are not marked yet
Replies
0
Views
37
RA Lille
K
Registration of a Medical Device in Lebanon
Replies
4
Views
3,045
supadrai
M
Medical Devices Sterility - Question from A Regulator
Replies
3
Views
88
Marcelo Antunes
F
China Clinical Trials Requirements
Replies
2
Views
69
fialor
L
Medtech regulation under scrutiny
Replies
1
Views
63
Marc
M
Strategy for Foreign Regulatory Compliance
Replies
4
Views
95
supadrai
K
Classification of IVF/ICSI devices (micromanipulator) in Mexico
Replies
0
Views
36
KGE
J
Medical Device Registration in Argentina - Client asks us to provide “European FSC”
Replies
3
Views
87
supadrai
J
Medical Device Regulation - Cambodia
Replies
6
Views
3,117
supadrai
supadrai
Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement.
Replies
0
Views
60
supadrai
F
India Medical Device Regulations - Update - 2017
2
Replies
11
Views
1,932
sriramsl
J
Brazil GMP license work with multiple BRH?
Replies
3
Views
77
Marcelo Antunes
X
Where to find UAE medical device registration regulation and guidelines
Replies
3
Views
2,665
Mark Meer
D
UAE IVD Registration (Professional Use Only, Non-A, Non-B of EU Regulation)
Replies
6
Views
4,037
Mark Meer
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