Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
Replies
1
Views
649
Ashwathy Warrier
V
OEM / PLM Japan
Replies
0
Views
698
vicky012
M
Medical device package insert in EU and USA
Replies
2
Views
1,218
Watchcat
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
4
Views
1,146
marmary
J
Japan AE (Adverse Event) Reporting Requirements
Replies
5
Views
7,148
April
Ajit Basrur
Refurbisher of medical devices in Japan
Replies
0
Views
672
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
Replies
2
Views
2,786
maya_tanase
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
Replies
0
Views
1,414
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
Replies
4
Views
2,166
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
Replies
8
Views
5,699
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
Replies
1
Views
1,443
v9991
S
Looking for English Copy of MHLW 169 regulation
Replies
5
Views
3,905
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
Views
2,061
mylenerr
S
Scope change in Japan - Class I disposable medical devices
Replies
0
Views
998
smartinez
M
Are English translations required for Japanese Certs
Replies
1
Views
1,132
shimonv
You must log in or register to post here.
Top Bottom