Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
I
How to determine "generic/me too" device?
Replies
0
Views
366
itscloud
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
6
Views
2,866
hvk159
V
OEM / PLM Japan
Replies
1
Views
1,467
UNIJP
A
Medical Device Vigilance decision tree for Japan for class 2 devices.
Replies
1
Views
2,078
Ashwathy Warrier
M
Medical device package insert in EU and USA
Replies
2
Views
1,902
Watchcat
J
Japan AE (Adverse Event) Reporting Requirements
Replies
5
Views
9,794
April
Ajit Basrur
Refurbisher of medical devices in Japan
Replies
0
Views
1,269
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
Replies
2
Views
3,599
maya_tanase
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
Replies
0
Views
2,256
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
Replies
4
Views
3,526
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
Replies
8
Views
7,017
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
Replies
1
Views
2,465
v9991
S
Looking for English Copy of MHLW 169 regulation
Replies
5
Views
5,722
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
Views
2,568
mylenerr
S
Scope change in Japan - Class I disposable medical devices
Replies
0
Views
1,196
smartinez
You must log in or register to post here.
Top Bottom