Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
M
Medical device package insert in EU and USA
Replies
2
Views
811
Watchcat
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
4
Views
724
marmary
J
Japan AE (Adverse Event) Reporting Requirements
Replies
5
Views
5,869
April
Ajit Basrur
Refurbisher of medical devices in Japan
Replies
0
Views
361
Ajit Basrur
G
More than one Marketing Authorization Holder (MAH) in Japan
Replies
2
Views
2,370
maya_tanase
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
Replies
0
Views
969
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
Replies
4
Views
1,503
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
Replies
8
Views
4,990
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
Replies
1
Views
950
v9991
S
Looking for English Copy of MHLW 169 regulation
Replies
5
Views
3,101
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
Views
1,635
mylenerr
S
Scope change in Japan - Class I disposable medical devices
Replies
0
Views
861
smartinez
M
Are English translations required for Japanese Certs
Replies
1
Views
1,012
shimonv
B
Request for Information; Application for Accreditation
Replies
0
Views
532
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
Replies
0
Views
642
QM Becky
You must log in or register to post here.
Top Bottom