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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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Japan Medical Device Regulations
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
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Looking for a Japan MAH recommendation that is not too expensive
FDASurveillance
Mar 20, 2019
Replies
5
Views
1,848
Dec 17, 2020
UNIJP
V
OEM / PLM Japan
vicky012
Feb 5, 2020
Replies
1
Views
1,087
Dec 17, 2020
UNIJP
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
Ashwathy Warrier
May 14, 2020
Replies
1
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1,595
May 14, 2020
Ashwathy Warrier
M
Medical device package insert in EU and USA
med_cert
Feb 20, 2019
Replies
2
Views
1,549
Oct 29, 2019
Watchcat
J
Japan AE (Adverse Event) Reporting Requirements
jinglot
Jun 20, 2017
Replies
5
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8,474
Jun 10, 2019
April
Refurbisher of medical devices in Japan
Ajit Basrur
Jun 3, 2019
Replies
0
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944
Jun 3, 2019
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
goodnature
Apr 3, 2013
Replies
2
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3,179
Mar 20, 2019
maya_tanase
Informational
Japan Minor Change Notification Application Form - Found it?
supadrai
Oct 25, 2018
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0
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1,856
Oct 25, 2018
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
IndochineHH
Oct 4, 2018
Replies
4
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2,832
Oct 17, 2018
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
enrevanche
Aug 31, 2016
Replies
8
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6,361
Oct 12, 2018
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
JeantheBigone
Aug 15, 2018
Replies
1
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1,918
Sep 9, 2018
v9991
S
Looking for English Copy of MHLW 169 regulation
Sue789
Oct 31, 2017
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5
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4,750
Aug 15, 2018
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
jkc3usc
Apr 3, 2018
Replies
9
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2,361
Aug 14, 2018
mylenerr
S
Scope change in Japan - Class I disposable medical devices
smartinez
Jul 11, 2018
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0
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1,084
Jul 11, 2018
smartinez
M
Are English translations required for Japanese Certs
medic61
May 10, 2018
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1
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1,234
May 11, 2018
shimonv
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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