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)
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Replies
128
Views
20,453
max.polix
Marcelo Antunes
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Medical Device Registration Process in Brazil - Anvisa (Part 1)
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Replies
301
Views
104,749
Marc
Marcelo Antunes
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Medical Equipment Inmetro Certification Process in Brazil - Part 1
2 3 4 5
Replies
47
Views
20,259
Marcelo Antunes
R
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Medical Device Approval in Brazil - Understanding INMETRO and ANVISA
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Replies
120
Views
30,707
Marcelo Antunes
Marcelo Antunes
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Guidance for Medical Device Registration in Med Dev Regulations World-Wide
2 3
Replies
22
Views
9,552
Marcelo Antunes
Marc
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Medical Equipment Inmetro Certification Process in Brazil - Part 2
Replies
3
Views
3,728
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
18,244
Marc
Marcelo Antunes
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Future revision of ANVISA RDC 59 - Brazilian GMP
2
Replies
14
Views
8,927
Marcelo Antunes
Discussions
M
Medical Device Registration in Venezuela
Replies
6
Views
4,160
biokeithmed
Ajit Basrur
New Medical Device and IVD Registration Rules - Pakistan
Replies
4
Views
2,246
lynchoid
J
Pre-clinical Studies for RUO Product
Replies
1
Views
42
Ronen E
C
Can a manufacturer(in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name?
Replies
0
Views
30
Cindy
Y
Can there be multiple Brazil Registration Holder (BRH) for same model ?
Replies
3
Views
2,528
Cindy
C
What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia?
Replies
0
Views
45
CrystalRose
E
South Korea, MFDS - GMP inspections
Replies
3
Views
268
HJCho
S
Adverse Event and Serious Adverse Event Reporting - Korea
Replies
4
Views
1,185
Enrico Greco
S
Indian Medical Device Rule - January 29th, 2017
2 3
Replies
22
Views
3,599
Ramya
R
Clinical validation/investigation in Egypt - Medical Devices sevices that are not marked yet
Replies
4
Views
367
SKM.Sunil
P
Can someone share their experience with KFDA Inspection ?
2 3 4
Replies
30
Views
10,925
Wolf.K
M
Exemption Clauses for Research, Demonstration, etc.
Replies
2
Views
96
Ronen E
rob73
Worldwide device regulatory authorities at country level
Replies
6
Views
1,421
rob73
B
MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record
Replies
2
Views
141
Edward Reesor
A
Japan's Requirements for Reporting Medical Device Adverse Events
Replies
2
Views
171
April
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