Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations of new and updated requirements planned through 2022.
The first round of changes to Japan’s Pharmaceutical and Medical Products Act (PMD Act) took effect September 1, 2020. Additional revisions will come into force in August 2021 and December 2022.
On a high level, PMD Act revisions will include new regulatory pathways for some medical products; additional roles and responsibilities for pharmacies in Japan; and clarified requirements for compliance frameworks for licensed entities dealing with medical devices, IVDs and other medical products.
Japanese market registrants should also anticipate stricter procedures for private importation of unregistered medical products as well as stiffer penalties for PMD Act violations, according to Emergo by UL consultants in Tokyo…