July 2024 KD&A Blog – Updates to Medical Device Regulations

Various changes have been made to the regulation of numerous types of medical devices by the TGA, including software-based medical devices, prescription spectacle lenses, medical devices containing microbial, recombinant, or animal substances, and medical device application audit requirements. The changes to software-based medical devices and prescription spectacle lenses came into effect on June 15th, 2024, and updates for medical devices containing microbial, recombinant, or animal substances and medical device application audit requirements were enforced on July 1st, 2024.

Key Changes

Medical Devices with Microbial, Recombinant, or Animal Substances

Effective July 1, 2024:

• Revised Classification Rule 5.5: Applies to devices containing non-viable animal tissues or cells (excluding hair or wool) and their derivatives (excluding sintered hydroxyapatite or tallow derivatives).
• New Applications: Must align with the updated Rule 5.5 and other relevant classification rules.
• Existing Entries: Sponsors must submit reclassification applications by July 1, 2026, and can continue to supply, unless the reclassification application is unsuccessful.
• Conformity Evidence: Now accepted from a wider range of international approvals due to changes in the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.

Software-Based Medical Devices

From June 15, 2024:

• Transition Pathway: Manufacturers or sponsors with transitional ARTG entries must submit a TGA conformity assessment certificate application or ARTG inclusion application by November 1, 2024, to continue supply beyond this date.

Medical Device Application Audits

Starting July 1, 2024:

• Audit Focus: Mandatory audits will be limited to high-risk medical devices and IVDs.
• Class III Pathway: A new reliance pathway is available for Class III devices with MDSAP certification and US FDA 510(k) approval.
• Audit Requirements: Mandatory audits for Class III devices with EU MDD certification and Class 3 and 4 IVDs supported by MDSAP, ISO 13485, or EU IVD Directive certifications.
• Additional Documentation: Class III inclusion applications must now include a Clinical Evaluation Report (CER) and Instructions For Use (IFU), except for those with TGA-issued conformity assessment certificates.

Prescription Spectacle Lenses

From June 15, 2024

• Exemption: Prescription spectacle lenses are exempt from inclusion in the ARTG for import, export, or supply in Australia. More information can be found at the TGA webpage.

In summary, these regulatory updates by the TGA aim to enhance the safety, quality, and performance of medical devices in Australia. Manufacturers and sponsors should ensure compliance with these new requirements to maintain market access and success.