Anon,
This is managed by the Marketing Authorisation Holder (MAH) in Japan under Good Vigilance Practice (GVP) defined in MO 35. The MDSAP was written this way because the GVP reporting in Japan is managed by the MAH and sort of "out of the hands" of the Manufacturer. However, it would be a good process to have a closed-loop with the MAH between the Manufacturer to show the communication to the MAH and then the MAH confirming notification sent to PMDA.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Nov-2023 05:19
From: Olga Peycheva
Subject: Medical Device Reporting by MAH in Japan
Hello,
Check if this will help you - https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html
When you open a document you have to click on the globe in the upper right corner and it will show you bilingual version of the document.
Have a great day,
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
https://solutionsop.co.uk/
United Kingdom
Original Message:
Sent: 31-Oct-2023 11:14
From: Anonymous Member
Subject: Medical Device Reporting by MAH in Japan
This message was posted by a user wishing to remain anonymous
We are a medical device manufacturer in the US with an MAH in Japan. According to the MDSAP workbook, the manufacturer has to show proof of notification of a complaint to the MAH, but does not require proof of the MAH reportability decision, or a copy of any regulatory report submitted by the MAH. I am trying to find the regulations outlining this requirement but I cannot find it. I was assuming that as the legal manufacturer proof of the reporting decision and submission of reporting by the MAH would be required to be in the complaint file owned by the manufacturer. Does anyone have the actual regulations outlining this requirement?
Thank you.