Australia TGA Regulatory Update – Are You Ready?

Do you have Australia as a jurisdiction in you QMS scope? Recent changes to the MDSAP Audit Approach P0002.10 published on Feb 2, 2026 have updated some TGA requirements. Though the following requirements have been updated since 2025; it is officially being published on the MDSAP so audits in 2026 will be audited against the new requirements, if it hasn't already.

Firstly, Chapter 4 should be revised to reference the PRAC instead of the URTPG this is a quick jump out for auditors to find whether the recall procedure is up to date or not. Secondly, Chapter 2 of the MDSAP technical documentation will also need to be updated, especially for those who have SaMD (software as a medical device). Updated Essentials Principles checklist can be found here.

Before you prepare for your 2026 MDSAP audit - it is highly recommended to do an interim audit for the most updated QMSR and Australia requirements before you get specific findings on these two sections. Email us today for a consultation on a gap assessment and schedule your internal audit with us today! We also offer a very affordable eQMS - contact us for a demo today!