Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Discussions
J
Japan AE (Adverse Event) Reporting Requirements
Replies
5
Views
4,567
April
Ajit Basrur
Refurbisher of medical devices in Japan
Replies
0
Views
81
Ajit Basrur
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
3
Views
313
Edugar
G
More than one Marketing Authorization Holder (MAH) in Japan
Replies
2
Views
1,997
maya_tanase
M
Medical device package insert in EU and USA
Replies
0
Views
208
med_cert
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
Replies
0
Views
314
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
Replies
4
Views
892
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
Replies
8
Views
4,215
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
Replies
1
Views
584
v9991
S
Looking for English Copy of MHLW 169 regulation
Replies
5
Views
2,435
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
Views
1,291
mylenerr
S
Scope change in Japan - Class I disposable medical devices
Replies
0
Views
607
smartinez
M
Are English translations required for Japanese Certs
Replies
1
Views
822
shimonv
B
Request for Information; Application for Accreditation
Replies
0
Views
457
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
Replies
0
Views
512
QM Becky
You must log in or register to post here.
Top Bottom