The Therapeutic Goods Administration (TGA) inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on 1 October 2020, for Class I non-measuring, non-sterile medical devices.
The key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG are outlined as follows:
1. 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.
2. The manufacturer's Declaration of Conformity template for Class I non-sterile, non-measuring devices has been revised to be more user-friendly.
3. TGA will assess applications for compliance with the legal requirements for Class I medical devices to be included in the ARTG.
4. 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; or
- - 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.
5. TGA may conduct non-mandatory audits of Class I medical devices or Class 1 IVD 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.
6. You can check if your product is a medical device using the SME Assist tool.
7. All Class I medical devices and Class 1 IVD medical devices included in the ARTG will continue to be subject to post-market reviews, in accordance with the existing process.
A particular note is that these changes, effective from 1 October 2020 and 4 December 2020 for Class I medical devices and Class 1 IVD medical devices respectively, also apply to Class I Export Only and Class I IVD Export Only medical devices as of 20 May 2021, in accordance with the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures - Class I Medical Devices) Determination 2020.