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Please indicate your consent by completing this form and sending it with your application for a new medical device licence, or any time after a licence has been granted. This page contains information on when a medical device license is required, applying for a medical device licence and what to do before submitting a medical device application. This guidance provides information to manufacturers and regulatory correspondents on how to complete an application form for a new medical device licence

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This guidance applies to all new class ii, iii and iv medical devices. This document describes how to complete an application for a new medical device licence for class ii, iii and iv medical devices, including payment of applicable fees. To provide information to manufacturers and regulatory correspondents on how to complete an application form for a new medical device licence