Japan’s medical device regulators have updated processes and procedures that manufacturers and suppliers must comply with in order to obtain Japanese market access. These latest changes include revisions to the Pharmaceuticals and Medical Devices (PMD) Act and the online submission process. All links below are in Japanese.
Act on Partial Revision of the Pharmaceuticals and Medical Devices Act
Japan’s Ministry of Health, Labour and Welfare (MHLW) has published the Act on Partial Revision of the Pharmaceuticals and Medical Devices Act (Act No. 47, dated May 20, 2022).
The revised guidelines introduce an emergency approval system and establish an electronic prescription system. Manufacturers should take note that Act No. 47 adds a new Article 23-2-6-2, which stipulates medical devices and in vitro diagnostic (IVD) devices meeting certain criteria may receive approval for a period of not more than two years…