Japan’s medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code labeling laws. Manufacturers should become familiar with these changes to maintain compliance and ensure market access. All links below are in Japanese.
MHLW Order No. 128, Partial Revision of the Regulation for Enforcement of the PMD Act
Japan’s Ministry of Health, Labour and Welfare (MHLW) has released Order No. 128, which is intended to revise portions of the Regulation for Enforcement of the Pharmaceuticals and Medical Devices Act (MHLW Order No. 1 of February 1, 1961). The order will become effective on December 1, 2022…
