Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
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Japan AE (Adverse Event) Reporting Requirements
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5
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4,940
April
Ajit Basrur
Refurbisher of medical devices in Japan
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0
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167
Ajit Basrur
F
Looking for a Japan MAH recommendation that is not too expensive
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3
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407
Edugar
G
More than one Marketing Authorization Holder (MAH) in Japan
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2
Views
2,088
maya_tanase
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Medical device package insert in EU and USA
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0
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288
med_cert
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
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0
Views
385
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
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4
Views
1,059
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
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8
Views
4,395
Choi Kyoung-Ho
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Medical Devices in Japan - Conformity of QMS to ISO 13485
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1
Views
701
v9991
S
Looking for English Copy of MHLW 169 regulation
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5
Views
2,634
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
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9
Views
1,392
mylenerr
S
Scope change in Japan - Class I disposable medical devices
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0
Views
675
smartinez
M
Are English translations required for Japanese Certs
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1
Views
843
shimonv
B
Request for Information; Application for Accreditation
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0
Views
485
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
Replies
0
Views
541
QM Becky
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