Other Medical Device Regulations World-Wide

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

FAQs
Marcelo Antunes
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Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)
4 5 6 7 8 9 10 11 12 13
Replies
125
Views
19,723
JonthanR
Marcelo Antunes
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Medical Device Registration Process in Brazil - Anvisa (Part 1)
22 23 24 25 26 27 28 29 30 31
Replies
301
Views
103,859
Marc
Marcelo Antunes
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Medical Equipment Inmetro Certification Process in Brazil - Part 1
2 3 4 5
Replies
47
Views
19,850
Marcelo Antunes
R
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Medical Device Approval in Brazil - Understanding INMETRO and ANVISA
4 5 6 7 8 9 10 11 12 13
Replies
120
Views
30,052
Marcelo Antunes
Marcelo Antunes
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Guidance for Medical Device Registration in Med Dev Regulations World-Wide
2 3
Replies
22
Views
9,174
Marcelo Antunes
Marc
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Medical Equipment Inmetro Certification Process in Brazil - Part 2
Replies
3
Views
3,541
Marcelo Antunes
Marcelo Antunes
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Medical Device Registration Process in Brazil - Anvisa (Part 2)
2 3 4 5 6 7 8
Replies
71
Views
17,837
Marc
Marcelo Antunes
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Future revision of ANVISA RDC 59 - Brazilian GMP
2
Replies
14
Views
8,708
Marcelo Antunes
Discussions
T
Morocco Medical Device Product Registration
2
Replies
13
Views
5,016
Berni
B
MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record
Replies
0
Views
44
Bernard Mulcahy
J
Australian TGA Sponsor costs
Replies
3
Views
100
medwise
D
Medical Device Regulations in Bermuda
Replies
4
Views
2,865
JJ in QA
Marcelo Antunes
Medical Device News INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets
Replies
7
Views
2,930
Marcelo Antunes
H
List of Language requirements for Jordan, Iraq, Libya, Oman, Lebanon, UAE, Yemen, Sau
Replies
7
Views
4,962
Nenad29m
S
Compliance to Brazil GMP requirements
2
Replies
12
Views
1,474
SylvieS
J
Ethicon suture box design changes - 2019
Replies
2
Views
76
Marc
Marc
European universities dismal at reporting results of clinical trials - 2019
Replies
0
Views
52
Marc
XRAY_3121
Design and Development Requirement - MDSAP Audit Finding
Replies
4
Views
263
Ronen E
A
Australia TGA Medical Device Sponsor Agreement - Example or Template
Replies
5
Views
255
Eddyo
C
Vietnam - Authorized Medical Device Representative Change
Replies
7
Views
854
David Vo
P
Can someone share their experience with KFDA Inspection ?
2 3
Replies
27
Views
10,674
Jean_B
Z
CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registration
Replies
6
Views
3,209
Sicco
A
How should the Medical Device OEMs be declared to ANVISA?
Replies
0
Views
49
apuigvert
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