Japan’s PMDA Pre-Submission consultation program for medical devices

In this white paper, you will learn what to expect from Japan’s PMDA Pre-Submission consultation program.

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This white paper is intended to provide an overview of Japan’s PMDA Pre-Submission consultation program, a mechanism available to manufacturers through which they can request feedback from, or a consultation meeting with, the Pharmaceuticals and Medical Devices Agency (PMDA). These communications may pertain to potential or planned medical device Premarket Approval (PMA), a notification of clinical study plan, regulatory strategy and approach, or other facets of the market access process.