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Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
F
Looking for a Japan MAH recommendation that is not too expensive
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6
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2,521
hvk159
V
OEM / PLM Japan
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1
Views
1,291
UNIJP
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
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1
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1,861
Ashwathy Warrier
M
Medical device package insert in EU and USA
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2
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1,747
Watchcat
J
Japan AE (Adverse Event) Reporting Requirements
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5
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9,234
April
Ajit Basrur
Refurbisher of medical devices in Japan
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0
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1,120
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
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2
Views
3,396
maya_tanase
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
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0
Views
2,068
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
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4
Views
3,181
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
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8
Views
6,718
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
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1
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2,206
v9991
S
Looking for English Copy of MHLW 169 regulation
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5
Views
5,284
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
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9
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2,482
mylenerr
S
Scope change in Japan - Class I disposable medical devices
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0
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1,146
smartinez
M
Are English translations required for Japanese Certs
Replies
1
Views
1,304
shimonv
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