Yes, there has been discussion in this forum over the past few years.
Japan to Establish Digital Repository of Medical Device Safety Info. Manufacturers will be Required to Post Package Insert Information to it
Japanese Package insert
eIFU Requirements for Japan
Also info from PMDA: https://www.pmda.go.jp/files/000232161.pdf
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Anne LeBlanc
United States
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Original Message:
Sent: 13-Jul-2023 07:19
From: Rashmi Pillay
Subject: Japan QR code
Hi,
Is anybody aware of the latest QR code requirement of Japan(effective from 1st August'23) required in addition to the UDI label ?
Thanks & Regards,
|  | Rashmi Pillay Regulatory Affairs Manager Ellex – Lumibird Medical group 3-4 Second Avenue, Mawson lakes SA 5095 Tel. +61 8 7074 8105 Email :rpillay@ellex.com |
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