The Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination (No. 2) 2024, effective from 19 October 2024, introduces key changes to the documentation required for including certain medical devices in the Australian Register of Therapeutic Goods (ARTG). These amendments aim to streamline the application process, particularly for devices assessed by the United States Food and Drug Administration (US FDA).

Key Amendments:

1. Class IIa Medical Devices:

For devices that are not exempted by the US FDA from section 510(k) requirements of the Federal Food, Drug, and Cosmetic Act, applicants must submit a Medical Device Single Audit Program (MDSAP) certificate issued by a recognized auditing organization. Additionally, they are required to provide either a determination of substantial equivalence under section 510(k) or an order granting a De Novo classification request under section 513 of the US FDA Act. This clarification ensures that the requirements for non-exempt devices are aligned with international regulatory practices, providing transparency and flexibility in compliance pathways.

2. Class III Medical Devices:

Applicants can now submit either an order approving a premarket approval application under section 515 or a determination of substantial equivalence concerning a notification under section 510(k) of the US FDA. This change offers greater flexibility in the types of US FDA conformity assessment documents acceptable for product assessment. 

3. Editorial Corrections:

Minor corrections have been made to improve the clarity of the Principal Determination, including the insertion of the heading "Class III medical devices" before subsection 5(7) and the removal of outdated references. 

These amendments are designed to reduce regulatory burdens by aligning Australian requirements with international assessments, thereby facilitating quicker access to medical devices that meet established safety and performance standards.

The TGA’s latest update introduces greater regulatory flexibility, offering opportunities for streamlined compliance and faster market access. At Qualtech Consulting Corporation, we’re here to help you leverage these changes to your advantage. Our experts will guide you in navigating the new documentation pathways and aligning with international standards, ensuring your medical devices meet all requirements efficiently. Take advantage of these regulatory enhancements—partner with us to optimize your compliance strategy and stay informed about future updates that could further benefit your business. Stay ahead with Qualtech Consulting Corporation.

 

For detailed information, refer to the official explanatory statement provided by the Australian Government. 

 

 

References:

1. Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
2. Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination (No. 2) 2024