Electronic Instructions for Use | 合法醫療器材資訊網

2018年8月15日—Newguidanceonelectronicinstructionsforuseformedicaldevices....providedwithamedicaldevice|RequirementsfortheprovisionofeIFU ...

The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets regulations, and thus indicate how to comply.

This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.

This document will evolve over time and updates and clarifications will be included as required. Feedback on the guidance is always welcome.

Introduction

This guidance is for manufacturers of medical devices who may be considering supplying the instructions for use of their device in an electronic or online format.

Note

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