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

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.

REFERENCE:  Emergo Group; 30 JUL 2014; Stewart Eisenhart

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