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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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Informational
Japan Minor Change Notification Application Form - Found it?
supadrai
Oct 25, 2018
Replies
0
Views
82
Oct 25, 2018
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
IndochineHH
Oct 4, 2018
Replies
4
Views
247
Oct 17, 2018
supadrai
E
Attachment browser
Source for The Enforcement Regulations in English - Article 228-20
enrevanche
Aug 31, 2016
Replies
8
Views
3,473
Oct 12, 2018
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
JeantheBigone
Aug 15, 2018
Replies
1
Views
246
Sep 9, 2018
v9991
S
Attachment browser
Looking for English Copy of MHLW 169 regulation
Sue789
Oct 31, 2017
Replies
5
Views
1,783
Aug 15, 2018
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
jkc3usc
Apr 3, 2018
Replies
9
Views
957
Aug 14, 2018
mylenerr
S
Scope change in Japan - Class I disposable medical devices
smartinez
Jul 11, 2018
Replies
0
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450
Jul 11, 2018
smartinez
M
Are English translations required for Japanese Certs
medic61
May 10, 2018
Replies
1
Views
654
May 11, 2018
shimonv
J
Attachment browser
Japan AE (Adverse Event) Reporting Requirements
jinglot
Jun 20, 2017
Replies
3
Views
3,587
Apr 11, 2018
jkc3usc
B
Request for Information; Application for Accreditation
bender991
Apr 10, 2018
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0
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306
Apr 10, 2018
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
QM Becky
Mar 22, 2018
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0
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328
Mar 22, 2018
QM Becky
J
Japan's Definition of Should and Shall
jiligan
Oct 31, 2017
Replies
1
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1,164
Nov 1, 2017
Ajit Basrur
I
UDI requirements vs Japanese Barcode Marking guideline
iVivien
Jun 12, 2015
Replies
1
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2,625
Oct 3, 2017
miken99
C
Does Japan accept the Bracketing Approach for Process Validation
CSH_3
Apr 26, 2017
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1
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1,756
Apr 26, 2017
redmonkey2
P
Japan MHLW Ordinance No 94. (QMS structure Regulation)
pdzip2
Apr 12, 2017
Replies
1
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1,794
Apr 24, 2017
Marc
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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