Informational Japan Minor Change Notification Application Form - Found it?

#1
Hi All,

This MCN form took me ages to track down, can anyone confirm? Google translate seems to confirm it is what I think it is. But is this the Form No. 6 referenced in the official "Application for Accreditation of Foreign Manufacturers" published by the PDMA PMDA. (both attached) Particularly, I'm concerned its only for Pharmaceuticals and not medical devices.

Thanks in advance!

:beerdive: and happy Friday from this side of the International Dateline!
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Minor/ Major Change - Japan - When you have to notify the PMDA of a change? Other Medical Device Regulations World-Wide 1
V Procedure to notify Health Canada, FDA and Japan Pal for Minor Design Changes Canada Medical Device Regulations 5
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
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
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
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
J Japan AE (Adverse Event) Reporting Requirements Japan Medical Device Regulations 5
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
R Reporting Times & Requirements for when an Adverse Event has occurred (Japan) Japan Medical Device Regulations 3
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
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