Japan AE (Adverse Event) Reporting Requirements

jinglot

Starting to get Involved
#1
Hi! I am finding conflicting information online and not much in English regarding reporting requirements in Japan. Some main questions:

1. Are AEs outside of Japan reportable to PMDA?
2. Are AEs that are already provided in labeling reportable?

If anyone has a decision tree that they are willing to share, that would be super helpful as well...

Thank you in advance!!!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
R Reporting Times & Requirements for when an Adverse Event has occurred (Japan) Japan Medical Device Regulations 3
C Adverse Event Reporting in Japan Japan Medical Device Regulations 8
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
V OEM / PLM Japan Japan Medical Device Regulations 0
M Brazil and Japan - Essential requirements Other Medical Device Regulations World-Wide 3
Ajit Basrur Refurbisher of medical devices in Japan Japan Medical Device Regulations 0
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 4
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
Q JIS T 1115 Comparison (Japan Medical Device Standard) Japan Medical Device Regulations 0
J Japan's Definition of Should and Shall Japan Medical Device Regulations 1
shimonv Off-Label Use of a Medical Device in Japan Other Medical Device Regulations World-Wide 2
J MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US ISO 13485:2016 - Medical Device Quality Management Systems 3
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
P Japan MHLW Ordinance No 94. (QMS structure Regulation) Japan Medical Device Regulations 1
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
E IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law Japan Medical Device Regulations 2
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
F If Japan Can?Why Can?t We? (Claire Crawford-Mason) Philosophy, Gurus, Innovation and Evolution 3
R Selling of Medical Power Supply in Australia/New Zealand and Japan Other Medical Device Regulations World-Wide 5
C Japan Regulations - Resistance of Medical Gloves to Permeation Japan Medical Device Regulations 1
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
B Japan Medical Device Recall Requirements Japan Medical Device Regulations 4
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
E Japan - Medical Device Classification for Mass Spectrometry Japan Medical Device Regulations 2
B Japan PAL QMS Audit Experience Other Medical Device and Orthopedic Related Topics 5
C Revision of Japan's Pharmaceutical Affairs Law (PAL) in 2014 Japan Medical Device Regulations 10
J EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico EU Medical Device Regulations 1
P Japan Requlatory Requirement for Nerve Scaffold using Human Tissue Japan Medical Device Regulations 2
D Japan Rules for Marketing Authorization Holders Japan Medical Device Regulations 1
P Sampling QC Requirements for Medical Electrical Device Export to Japan Japan Medical Device Regulations 1
N Barcode Registration Requirements for Japan and GUDID Japan Medical Device Regulations 2
N Need guidance on registration of medical device with MHLW (Japan) Japan Medical Device Regulations 1
S QMS to demonstrate Compliance to Canada, Europe and Japan Other Medical Device Regulations World-Wide 7
R Equivalent CE for export to Japan - Stand exibition with LED lights CE Marking (Conformité Européene) / CB Scheme 3
F Biocompatibility study conducted in the GLP lab outside Japan Japan Medical Device Regulations 2
G More than one Marketing Authorization Holder (MAH) in Japan Japan Medical Device Regulations 2
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
AnaMariaVR2 A Bold New Direction for Japan's Economy Coffee Break and Water Cooler Discussions 0
A Japan - Medical Device Classification for Autoclave Tape Japan Medical Device Regulations 6
R Hospital Grade Mains Plug US (NEMA 5-15) and Japan IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Differences in Medical Device Approvals in various countries (US, EU, Japan) Other Medical Device Regulations World-Wide 1
M Minor/ Major Change - Japan - When you have to notify the PMDA of a change? Other Medical Device Regulations World-Wide 1
F Class III Medical Device (Contact Lenses) Registration Timescale in Japan Japan Medical Device Regulations 4
A Aesthetic Treatment Medical Devices in Japan Japan Medical Device Regulations 2
Similar threads


















































Top Bottom