Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
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1
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1,138
Ashwathy Warrier
V
OEM / PLM Japan
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0
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844
vicky012
M
Medical device package insert in EU and USA
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2
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1,349
Watchcat
F
Looking for a Japan MAH recommendation that is not too expensive
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4
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1,320
marmary
J
Japan AE (Adverse Event) Reporting Requirements
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5
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7,816
April
Ajit Basrur
Refurbisher of medical devices in Japan
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0
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789
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
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2
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2,942
maya_tanase
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
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0
Views
1,590
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
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4
Views
2,413
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
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8
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5,982
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
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1
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1,629
v9991
S
Looking for English Copy of MHLW 169 regulation
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5
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4,252
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
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2,199
mylenerr
S
Scope change in Japan - Class I disposable medical devices
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0
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1,035
smartinez
M
Are English translations required for Japanese Certs
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1
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1,175
shimonv
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