Jul 30, 2014
The Japanese government has set an enforcement date of November 25, 2014 for revised laws that regulate the country’s pharmaceutical and medical device markets.
The revised Pharmaceutical Affairs Law (PAL) will include expanded third-party certification options for some Class III devices, streamlined quality system inspections, and accelerated review pathways for devices the Japanese government deems highly necessary for public health. Many of the planned regulatory changes are expected to provide a less onerous market authorization process for medical devices in Japan.
A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned changes to the country’s medical device market regulatory system.
Japan’s Ministry of Health, Labour and Welfare has exempted stability test report requirements for some medical devices submitted to the Pharmaceutical and Medical Devices Agency (PMDA) for registration.
Stability testing remains a requirement, however, for medical devices using new or innovative materials with little or no stability data, or that are structurally different enough from their predicate devices to require verification of stability. Testing requirements also remain for the following device types: