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Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
V
OEM / PLM Japan
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0
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308
vicky012
M
Medical device package insert in EU and USA
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2
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991
Watchcat
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
4
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857
marmary
J
Japan AE (Adverse Event) Reporting Requirements
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5
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6,322
April
Ajit Basrur
Refurbisher of medical devices in Japan
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0
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468
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
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2
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2,509
maya_tanase
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
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0
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1,111
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
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4
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1,711
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
Replies
8
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5,261
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
Replies
1
Views
1,105
v9991
S
Looking for English Copy of MHLW 169 regulation
Replies
5
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3,367
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
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1,768
mylenerr
S
Scope change in Japan - Class I disposable medical devices
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0
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910
smartinez
M
Are English translations required for Japanese Certs
Replies
1
Views
1,047
shimonv
B
Request for Information; Application for Accreditation
Replies
0
Views
576
bender991
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