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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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Discussions
Change of PVC stabilizer
Judy Abbott
May 10, 2022
Replies
6
Views
151
May 11, 2022
Judy Abbott
L
Saudi regulations for Japanese non sterile scopes
LOGI2004
Apr 30, 2022
Replies
0
Views
113
Apr 30, 2022
LOGI2004
B
Document retention Policy for Japan's PMDA
bill.Kal
Mar 7, 2022
Replies
1
Views
363
Mar 8, 2022
ECHO
D
Japan adverse event form
delement33
Feb 3, 2022
Replies
0
Views
302
Feb 3, 2022
delement33
M
PSE Certification
Malomsoki Gabor
Jan 18, 2022
Replies
5
Views
335
Feb 2, 2022
Malomsoki Gabor
B
Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs?
bill.Kal
Jan 24, 2022
Replies
0
Views
320
Jan 24, 2022
bill.Kal
J
Japan registration need manual without temperature reading
Jasmin
Nov 23, 2021
Replies
0
Views
507
Nov 23, 2021
Jasmin
K
MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics
Kate Gavin
Oct 28, 2021
Replies
2
Views
1,371
Nov 9, 2021
Seekingknowledgee
I
How to determine "generic/me too" device?
itscloud
Jul 22, 2021
Replies
0
Views
815
Jul 22, 2021
itscloud
F
Looking for a Japan MAH recommendation that is not too expensive
FDASurveillance
Mar 20, 2019
Replies
6
Views
3,398
Mar 15, 2021
hvk159
V
OEM / PLM Japan
vicky012
Feb 5, 2020
Replies
1
Views
1,844
Dec 17, 2020
UNIJP
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
Ashwathy Warrier
May 14, 2020
Replies
1
Views
2,541
May 14, 2020
Ashwathy Warrier
M
Medical device package insert in EU and USA
med_cert
Feb 20, 2019
Replies
2
Views
2,283
Oct 29, 2019
Watchcat
J
Japan AE (Adverse Event) Reporting Requirements
jinglot
Jun 20, 2017
Replies
5
Views
11,017
Jun 10, 2019
April
Refurbisher of medical devices in Japan
Ajit Basrur
Jun 3, 2019
Replies
0
Views
1,602
Jun 3, 2019
Ajit Basrur
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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