The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024. These revisions were impacting the regulation of:
Software-based Medical Devices
Medical Devices Containing Microbial, Recombinant, or Animal Substances
Medical Device Application Audit Requirements
New Reliance Pathway for Class III Medical Devices
Requirement for Class III Applications
Prescription Spectacle Lenses
i. Software-based Medical Devices
Transitional arrangements for software-based medical devices into higher risk classification will end on 1 November 2024.
However, TGA has amended the requirements to allow Sponsors who had notified TGA about their device transitions to a higher risk classification AND had applied for TGA conformity assessment certificate before 1 November 2024 to submit their application to include their device in the Australian Register of Therapeutic Goods (ARTG).
Effectively from 15 June 2024, Sponsors of devices transitioning to higher risk classifications were allowed to continue supplying their software-based medical devices past 1 November 2024 until their application is decided, if they submitted the requirements below by 1 November 2024:
An application for ARTG inclusion, OR
An application for TGA conformity assessment
ii. Medical Devices Containing Microbial, Recombinant, or Animal Substances
Amendments were made to the classification rule 5.5 and have been enforced starting 1 July 2024 only to medical devices that contain the following:
Non-viable tissues or cells, of animal origin (other than tissues or cells from hair or wool)
Derivatives of tissues or cells covered by the above (other than sintered hydroxyapatite or tallow derivatives)
Any devices containing substances of microbial or recombinant origin have been excluded from the rule and will continue to not apply to devices in contact with intact skin only. Sponsors are required to submit their reclassification applications before 1 July 2026, only if their ARTG entries were affected. Otherwise, Sponsors were allowed to continue supplying under their existing ARTG entries unless reclassification is unsuccessful.
New applications for medical devices containing microbial, recombinant, or animal substances must be classified under the latest classification rule 5.5 and other applicable classification rules.
Conformity Assessment Evidence Requirements
Starting 1 July 2024, the Therapeutic Goods (Medical Devices – Information that Must Accompany the Application for Inclusion) Amendment Determination 2024 has been enforced which includes the removal of references to specified medical devices. Hence, now the devices can be supported by comparable overseas approvals from a wider range of jurisdictions.
iii. Medical Device Application Audit Requirements
Mandatory application audits have been limited to high-risk medical devices and in vitro diagnostic (IVD) medical devices starting from 1 July 2024.
The audits will be applied to:
Class III medical devices – with support from
EU Medical Device Directive (MDD) certification
Medical Device Single Audit Program (MDSAP) certification and US FDA 510 (k) approval
Class III and IV IVDs, Class III and IV in-house IVDs, Self-Testing IVDs, & Point-of-Care Testing IVDs – with the following support of conformity assessment types:
MDSAP certification
ISO 13485 certification
EU IVD Directive certification
New reliance pathway established for Class III medical devices with MDSAP certification and US FDA 510(k) approval.
Therefore, Sponsors are required to include the Clinical Evaluation Report (CER) and Instruction for Use (IFU) during the submission of Class III inclusion applications. These requirements do not apply to Class III applications with conformity assessment certificates issued by TGA.
iv. Prescription Spectacle Lenses
Prescription Spectacle Lenses were exempted from the inclusion requirements in the ARTG effective from 15 June 2024, before import, export, or supply in Australia.
Contact us at info@arqon.com for more information.
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