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Guidance for Declaration of Conformity

For Class I non-sterile non-measuring, Class 1 in vitro diagnostic (IVD) medical devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)
20 May 2021
Download Guidance for Declaration of Conformity

Description

This guidance applies to the Declaration of Conformity procedures for Class I non-sterile, non measuring medical devices, Class 1 in vitro diagnostic (IVD) devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only), and Class I Systems and Procedure Packs.

This document is designed to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete.

Sponsors must obtain a Declaration of Conformity from the manufacturer to upload as part of their application for inclusion in the ARTG of a Class I non-sterile, non-measuring medical devices, Class 1 IVD devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only), and Class I Systems and Procedure Packs. This guidance is not legislative in nature and is subject to the requirements of therapeutic goods legislation. The Therapeutic Goods Administration (TGA) will continue to update this guidance as required.

  • About this guidance
    • Definitions
  • Declaration of conformity
    • Who needs to complete the form
    • Templates
    • Completing the Declaration of Conformity
      • Manufacturer's name
      • Business address
      • Classification
      • GMDN code and term
      • Standards applied to the device(s)
      • Name of the medical device(s) / IVD(s)
      • Essential Principles
      • Technical documentation
      • Post-market monitoring, reporting and corrective system
      • Declaration
      • Signature

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