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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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Japan Medical Device Regulations
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
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M
Does my "new" assay require a clinical study? or will a reference interval study suffice?
Mike W
Mar 21, 2024
Replies
0
Views
236
Mar 21, 2024
Mike W
M
A
Time limit for removing IVC Filter
Apple
Mar 18, 2024
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0
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111
Mar 18, 2024
Apple
A
Q
JMDN (Japanese Medical Device Nomenclature) codes list needed
QA-Man
Nov 4, 2008
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3
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24
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28K
Oct 11, 2023
ripunjoy
R
M
Outsourced Call Center (for complaints) and depth of required GVP/ISO13485 training
MED-T1
Oct 2, 2023
Replies
4
Views
604
Oct 9, 2023
MED-T1
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L
Multiple japanese mah
lacri
Sep 26, 2023
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0
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522
Sep 26, 2023
lacri
L
G
Copy of MHLW MO169 2014 and 2021
GP233_233
Sep 1, 2023
Replies
5
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697
Sep 12, 2023
paulag
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R
Establishment registration for subcontractors
Regsblue
Aug 23, 2023
Replies
1
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536
Aug 28, 2023
Orca1
N
Over labelling in Japan
Nat Nur
May 18, 2023
Replies
2
Views
943
Jun 22, 2023
Nat Nur
N
K
MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics
Kate Gavin
Oct 28, 2021
Replies
4
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8K
May 15, 2023
MED-T1
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R
Licensing Requirements for Third Party Logistics Providers
regularengineer
Feb 14, 2023
Replies
1
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877
Feb 24, 2023
regularengineer
R
S
File Conversion: Device or Non-Device?
SSchoepel
Feb 20, 2023
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0
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699
Feb 20, 2023
SSchoepel
S
M
English Language training on MHLW MO169?
MED-T1
Nov 9, 2022
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1
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1K
Nov 9, 2022
Soog1459
H
Need guidance on importation of Custom-made devices into Japan
Honex
Sep 13, 2022
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1
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1K
Sep 13, 2022
Enghabashy
D
Japan adverse event form
delement33
Feb 3, 2022
Replies
1
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1K
Sep 8, 2022
Soog1459
Change of PVC stabilizer
Judy Abbott
May 10, 2022
Replies
6
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2K
May 11, 2022
Judy Abbott
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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