Beginning in September, Japan will enforce recently codified amendments to its Pharmaceutical and Medical Device Act, affecting quality management, device registration, the regulation of medical software and third-party certifications. The new requirements, designed to guard against health problems associated with poorly regulated drugs and medical devices, establish a system for granting conditional early approvals of certain devices, along with a Ministry of Health, Labor and Welfare committee to monitor safety. Other amendments to the law, to be implemented over the next three years, include a mandate that manufacturers digitize prescribing information for pharmaceuticals and medical devices and use barcodes on product packaging. To market medical devices in Japan, manufacturers will need to be in compliance with the amended law.
