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Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices
Summary for sponsors
Changes to the process for including Class I non-sterile, non-measuring devices in the ARTG
From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) has changed. These changes do not at this stage apply to Class 1 IVD medical devices, Class I Export Only and Class I IVD Export Only devices.
This guidance outlines the key changes, and provides links to other TGA website pages to provide further information about including Class I devices in the ARTG.
Summary of changes
- Applicants need to provide a manufacturer's Declaration of Conformity with their application to include the device in the ARTG, rather than simply holding this documentation such a document at the time they apply for inclusion.
- The manufacturer's Declaration of Conformity form for Class I non-sterile, non-measuring devices has been revised to be more user-friendly.
- The TGA will assess applications for compliance with the legal requirements for Class I medical devices to be included in the ARTG.
- After conducting the assessment:
- If the TGA is not satisfied the product meets all the requirements for inclusion in the ARTG, the TGA will select the application for non-mandatory audit.
- if the TGA is satisfied the product meets all the requirements for inclusion in the ARTG , the TGA will include the device in the ARTG within four (4) business days of receiving the application.
- The TGA may conduct non-mandatory audits of Class I applications where (for example) there are concerns regarding a kind of device or it appears from the application that:
- The device is not a medical device;
- The device is incorrectly classified;
- The device does not comply with the essential principles;
- The device has not had the appropriate conformity assessment procedures applied to it; or
- The information supplied in or with the application is not complete or correct.
- You can check if your product is a medical device using the SME Assist tool.
- All Class I devices included in the ARTG will continue to be subject to post-market reviews, in accordance with the existing process.
Invitation to provide feedback
We invite sponsors of Class I medical devices to provide their feedback on the changes made to the process for including Class I non-sterile, non-measuring devices in the ARTG by answering an online survey.
These changes are in effect from 1 October 2020 in accordance with Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures—Class I Medical Devices) Determination 2020.