As everyone knows, not long ago the TGA announced that it will no longer accept applications for ISO 13485 certificates to support new in vitro diagnostic (IVD) medical devices, unless the manufacturer has made compliance with the EU IVD Directive before May 26, 2022. statement.

IVD medical devices that have been approved under the ISO 13485 certificate will need to transition to another acceptable manufacturer's evidence after the certificate expires to continue to be available on the market in Australia. This acceptable manufacturer evidence is mainly the use of evidence of market authorization from overseas regulators/assessment agencies.

For details, see:

https://www.tga.gov.au/resources/publication/publications/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds.

On 2023.06.23, the relevant content of the ISO13485 certificate cannot be used as the manufacturer's evidence for the IVD application was updated.

How can manufacturers/applicants be helped to identify the actions they must take as they transition to new manufacturer evidence? The TGA has published guidance on the transition of IVD medical devices to new manufacturer’s evidence to ensure continued regulatory compliance.

This guidance highlights that many sponsors and manufacturers of IVD medical devices will need to transition to new manufacturer evidence for two main reasons:

1) The new EU IVD Regulation 2017/746 (EU IVDR), which replaces the EU IVD Directive 98/79/EC (IVDD)

2) TGA no longer accepts ISO 13485 certificates to support applications for new in vitro diagnostic (IVD) medical devices, unless the manufacturer has made a declaration of conformity under the EU IVD Directive before May 26, 2022.

In addition, this guide also focuses on the two major aspects of the changes in the manufacturer's evidence requirements and the impact of the changes (measures that manufacturers should take during the transition period).

1. Requirements for change of manufacturer’s evidence

It is mainly described from the following four aspects:

1) Transition from EU IVDD to EU IVDR

2) Transition to ISO 13485 with EU Declaration of Conformity

3) Transition to ISO 13485 certification;

4) TGA deadline summary (important)

2. Impact of changes

This guide mainly outlines the possible aspects and measures that applicants must consider when transitioning to the new manufacturer's evidence from the following eight parts:

1) Update manufacturer evidence

2) Manufacturer's evidence that has expired or is about to expire;

3) Changes in classification due to changes in intended use;

4) Change to ARTG access information

5) Provisions that do not comply with the basic principles

6) Changes in the safety and performance of the device;

7) Changing the intended use of the device without changing the classification

8) Provision of a new device under current ARTG entry requirements

Note: The guide contains some examples below for each part for better understanding. You can download the specific guide at the following website:

https://www.tga.gov.au/sites/default/files/2023-06/transition-to-new-manufacturer-evidence-for-ivd-medical-devices.pdf

If your product wants to enter the Australian market, a manufacturer's evidence application must be submitted and accepted by TGA before submitting an application for medical device and in vitro diagnostic (IVD) products, but not all products require manufacturer's evidence (such as Class I non- Sterile, non-measurement medical devices, Class I IVD medical devices are not required).

What specific manufacturer evidence is available and how to submit manufacturer evidence? I will not go into details here. You can obtain detailed information and requirements through the following link:

https://www.tga.gov.au/manufacturer-evidence-medical-devices-including-ivd-medical-devices.

(Manufacturer Evidence for medical devices including IVD medical devices, updated on 2023.06.23)