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Japan ready to adopt new device approval system

This article was originally published in Clinica

Executive Summary

Proposed revisions to the Japanese Pharmaceutical Affairs Law (PAL), which have been drafted to bring local devices legislation into greater alignment with Global Harmonisation Task Force principles, are expected to be submitted to the Japanese parliament, the Diet, in early March. The new system will move the Japanese device regulatory system away from the current manufacturing approval-based system, to one based on marketing approval, as is the case in Europe and the US.

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