Reclassification of certain medical devices -Australia-TGA

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which amends the Therapeutic Goods (Medical Devices) Regulations 2002 to reclassify six categories of medical devices:

• spinal implantable medical devices

• active medical devices for therapy with diagnostic function

• active implantable medical devices and their accessories

• medical devices that administer medicines or biologicals by inhalation

• medical devices that consist of substances introduced into the body via a body orifice or applied to the skin

• medical devices used in direct contact with the heart, central circulatory or central nervous systems.

Five draft guidance documents on the reclassification of devices have been provided to the Regulatory and Technical Consultative Forum for medical devices in June 2020 for feedback.

Guidance is in development to include further information about the reclassifications and transitional arrangements for devices that are currently included in the ARTG.

The guidance about the new classification rules and transitional arrangements will be published once available.

• Reclassification of active medical devices for therapy with a diagnostic function

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

• Reclassification of active implantable medical devices (AIMD)

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active implantable medical devices will be required to be reclassified from Class AIMD to Class III.

• Reclassification of medical devices that administer medicines or biologicals by inhalation

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).