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Japan gears up for year of reform

This article was originally published in Clinica

Executive Summary

Japanese medical device regulators and advisors at home and overseas are preparing for a year of medical device regulatory reform and continuing dialogue on reimbursement and pricing under Prime Minister Koizumi's liberalisation drive. As of this month, it is expected that the device-related aspects of the Pharmaceutical Affairs Law (PAL) reform will begin to be filled out with up to 100 guidance documents, with European and US regulators and industry playing a role in the consultation.

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