Japan's amended PAL affects medical-device makers

01/13/2008 | Medical Device & Diagnostic Industry/DeviceTalk

One of the provisions of the revised Pharmaceutical Affairs Law in Japan aims to align the country's medical-device regulatory system with those of other developed countries. The amended PAL requires foreign device makers to appoint a marketing authorization holder as their representative in the country, acquire foreign manufacturing accreditation for their facilities and obtain approval from a third-party certification body for Class II medical devices.

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