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June 2026Japan’s Ministry of Health, Labour and Welfare (MHLW) has amended the list of general medical devices requiring enhanced manufacturing and quality control under Article 5-5, Paragraph 3 of the Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Medical Devices and In Vitro Diagnostic Medical Devices.
The amendment updates the list of designated devices subject to additional oversight, including the addition of the Portable Genetic Analyzer and the Optical Axial Length Measuring Device. Several existing device classifications have also been revised to reflect current regulatory requirements.
Manufacturers of affected devices must ensure compliance with the updated manufacturing and quality management standards to maintain product safety, quality, and regulatory conformity.
The revised notification strengthens oversight of designated general medical devices and supports consistent quality management throughout the product lifecycle in Japan.
Region: Japan
Source: https://www.mhlw.go.jp/hourei/doc/hourei/H260707I0010.pdf
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