TGA announces further refinements to the regulation of PMDs

The Therapeutic Goods Administration (TGA) has made further refinements to the regulation of personalised medical devices with the introduction of the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021.

The Amendment:

• Extends the deadline for stakeholders to register a patient-matched medical device for transition to inclusion in the Australian Register of Therapeutic Goods by 12 months to 25 August 2022.
• Introduces an exemption for patient-matched medical devices that are supplied in very low volumes, allowing the supply of up to five (5) devices each year without an inclusion in the ARTG.

The following web pages and guidance documents have been updated to reflect these refinements:

• The personalised medical devices landing page.
• Personalised medical devices (including 3D-printed devices).
• Custom-made medical devices landing page.

These refinements seek to address stakeholder concerns regarding their ability to meet their regulatory obligations and continue supplying personalised medical devices. 

Further consultation, both targeted and public, will be conducted by the TGA to identify additional refinements that could be made to ensure personalised medical devices are safe and fit for their intended purpose without imposing unnecessary administrative or regulatory burdens on businesses.