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Japan Medical Device Regulations

MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.

Discussions
F
Looking for a Japan MAH recommendation that is not too expensive
Replies
3
Views
161
Edugar
G
More than one Marketing Authorization Holder (MAH) in Japan
Replies
2
Views
1,864
maya_tanase
M
Medical device package insert in EU and USA
Replies
0
Views
98
med_cert
supadrai
Informational Japan Minor Change Notification Application Form - Found it?
Replies
0
Views
213
supadrai
I
Japanese medical device recall requirements & procedure for foreign manufacturers
Replies
4
Views
640
supadrai
E
Source for The Enforcement Regulations in English - Article 228-20
Replies
8
Views
3,916
Choi Kyoung-Ho
J
Medical Devices in Japan - Conformity of QMS to ISO 13485
Replies
1
Views
435
v9991
S
Looking for English Copy of MHLW 169 regulation
Replies
5
Views
2,138
JeantheBigone
J
GHTF Incidents - What does unlabeled and labeled mean?
Replies
9
Views
1,155
mylenerr
S
Scope change in Japan - Class I disposable medical devices
Replies
0
Views
539
smartinez
M
Are English translations required for Japanese Certs
Replies
1
Views
761
shimonv
J
Japan AE (Adverse Event) Reporting Requirements
Replies
3
Views
4,191
jkc3usc
B
Request for Information; Application for Accreditation
Replies
0
Views
399
bender991
Q
JIS T 1115 Comparison (Japan Medical Device Standard)
Replies
0
Views
450
QM Becky
J
Japan's Definition of Should and Shall
Replies
1
Views
1,255
Ajit Basrur
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