Japanese Regulators Announce Enforcement Date for New Medical Device and Drug Laws

 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.