Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.

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Discussions
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
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0
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149
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
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4
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450
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
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8
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3,702
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
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1
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330
v9991
S
Looking for English Copy of MHLW 169 regulation
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5
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1,961
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
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9
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1,076
mylenerr
S
Scope change in Japan - Class I disposable medical devices
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0
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496
smartinez
M
Are English translations required for Japanese Certs
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1
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695
shimonv
J
Japan AE (Adverse Event) Reporting Requirements
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3
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3,888
jkc3usc
B
Request for Information; Application for Accreditation
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0
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352
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
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0
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377
QM Becky
J
Japan's Definition of Should and Shall
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1
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1,207
Ajit Basrur
I
UDI requirements vs Japanese Barcode Marking guideline
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1
Views
2,714
miken99
C
Does Japan accept the Bracketing Approach for Process Validation
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1
Views
1,800
redmonkey2
P
Japan MHLW Ordinance No 94. (QMS structure Regulation)
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1
Views
1,880
Marc
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