When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different levels of evidence under Australian law.
The declaration of conformity provides sponsors and the TGA with information about medical devices to ensure compliance with the Essential Principles, the classification rules, and the appropriate conformity procedures, as provided under Australian legislation.
The declaration of conformity must be completed by the manufacturer or an authorised representative of the manufacturer. Manufacturers and sponsors have different responsibilities. A person or entity may be both the sponsor and manufacturer, provided they satisfy the relevant legal requirements and are aware of their ongoing responsibilities.
The declaration of conformity must be maintained and updated by the manufacturer. The manufacturer may hold a declaration of conformity made under the legislative provisions of other jurisdictions, however, authorized the TGA requires a copy of a declaration of conformity that satisfies the Australian legislative requirements.
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 in 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 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.
Also, there was additional guidance related to “Guidance for manufacturer's declaration of conformity for system or procedure packs”.
This document is to assist manufacturers of system or procedure packs in completing the declaration of conformity made under clause 7.5 for system or procedure packs (other than a Class I or Class 1 IVD system or procedure pack). Separate guidance is available to assist manufacturers of Class I or Class 1 IVD systems or procedure packs to make this declaration using a different template.
Comments