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
  • Sticky
Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)
3 4 5 6 7 8 9 10 11 12
Replies
119
Views
18,756
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
29,364
Marcelo Antunes
Marcelo Antunes
  • Sticky
Guidance for Medical Device Registration in Med Dev Regulations World-Wide
2 3
Replies
22
Views
8,856
Marcelo Antunes
Marc
  • Sticky
Medical Equipment Inmetro Certification Process in Brazil - Part 2
Replies
3
Views
3,463
Marcelo Antunes
Marcelo Antunes
  • Locked
  • Sticky
Medical Equipment Inmetro Certification Process in Brazil - Part 1
2 3 4 5
Replies
45
Views
19,419
Marc
Marc
  • Locked
  • Sticky
Medical Device Registration Process in Brazil - Anvisa (Part 2)
2 3 4 5 6 7 8
Replies
71
Views
17,308
Marc
Marcelo Antunes
  • Sticky
Future revision of ANVISA RDC 59 - Brazilian GMP
2
Replies
14
Views
8,582
Marcelo Antunes
Marcelo Antunes
  • Locked
  • Sticky
Medical Device Registration Process in Brazil - Anvisa (Part 1)
22 23 24 25 26 27 28 29 30 31
Replies
300
Views
102,643
Marcelo Antunes
Discussions
T
Morocco Medical Device Product Registration
Replies
7
Views
4,655
apuigvert
F
Guidance in English for PMS requirements for Taiwan
Replies
2
Views
93
Ronen E
C
Sponsor Agreement Requirements for Australia TGA
Replies
1
Views
66
Ronen E
E
Authorized Representative Change - Saudi Arabia
Replies
0
Views
39
Edugar
E
South Korea, MFDS - GMP inspections
Replies
0
Views
35
Edugar
A
Australia TGA Medical Device Sponsor Agreement - Example or Template
Replies
2
Views
73
Al Rosen
W
Syria Medical Device Regulations
Replies
5
Views
4,641
maya_tanase
M
Over-labelling - Any requirements or best-practices?
Replies
0
Views
80
Mark Meer
JoshuaFroud
Saudi Arabia - Insistence on a signed NB audit report (When one does not exist)
2
Replies
15
Views
1,086
Insyzor
I
Compressed air system qualification and 1 micron particle analysis
Replies
0
Views
59
ifserav
R
Medical device registration in Iran
Replies
0
Views
87
REG AFF BO RO
M
Medical Device Change Requirements - Malaysia Registered Products
Replies
3
Views
966
Mushroom
J0anne
GCC Submissions - Average review time for SGH qualification files
Replies
6
Views
1,497
J0anne
S
Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site
Replies
0
Views
232
Silvertabb
N
Medical Device Accessory Classification - Software as a Medical Device
Replies
5
Views
221
yodon
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