Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
Judy Abbott
Change of PVC stabilizer
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6
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151
Judy Abbott
L
Saudi regulations for Japanese non sterile scopes
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0
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113
LOGI2004
B
Document retention Policy for Japan's PMDA
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1
Views
363
ECHO
D
Japan adverse event form
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0
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302
delement33
M
PSE Certification
Replies
5
Views
335
Malomsoki Gabor
B
Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs?
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0
Views
320
bill.Kal
J
Japan registration need manual without temperature reading
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0
Views
507
Jasmin
K
MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics
Replies
2
Views
1,371
Seekingknowledgee
I
How to determine "generic/me too" device?
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0
Views
815
itscloud
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
6
Views
3,398
hvk159
V
OEM / PLM Japan
Replies
1
Views
1,844
UNIJP
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
Replies
1
Views
2,541
Ashwathy Warrier
M
Medical device package insert in EU and USA
Replies
2
Views
2,283
Watchcat
J
Japan AE (Adverse Event) Reporting Requirements
Replies
5
Views
11,017
April
Ajit Basrur
Refurbisher of medical devices in Japan
Replies
0
Views
1,602
Ajit Basrur
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