Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Forum Discussion Threads
I
Japanese medical device recall requirements & procedure for foreign manufacturers
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4
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101
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
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8
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3,234
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
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1
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183
v9991
S
Looking for English Copy of MHLW 169 regulation
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5
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1,657
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
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9
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871
mylenerr
S
Scope change in Japan - Class I disposable medical devices
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0
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409
smartinez
M
Are English translations required for Japanese Certs
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1
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617
shimonv
J
Japan AE (Adverse Event) Reporting Requirements
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3
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3,262
jkc3usc
B
Request for Information; Application for Accreditation
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0
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283
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
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0
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291
QM Becky
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