As Japan begins to enforce long-anticipated changes to its Pharmaceutical and Medical Device Act, it is ramping up penalties for violations of the new rules, which affect device registration, quality assurances, the regulation of medical software, and third-party certifications. But the changes also mean new opportunities for fast-track approval of pathbreaking medical technologies.
The first amendments to the law to go into effect, implemented in September by Japan’s Ministry of Health, Labor and Welfare, make it simpler for manufacturers of medical devices to make improvements to products without needing new approvals. The changes establish a system for granting conditional early approvals of certain devices and technologies for the treatment of life-threatening diseases, along with a regulatory committee to monitor safety.
Other new requirements, designed to guard against health problems associated with poorly regulated drugs and medical devices, to be implemented over the next two 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.