TGA announces major changes to regulation of software-based medical devices

The Therapeutic Goods Administration (TGA) has announced major changes to how software-based medical devices will be regulated under the Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act).

There are three types of software-based medical devices affected by the changes:

1. Devices referred to as 'programmed or programmable medical devices'.
2. Software that is a medical device.
3. Clinical decision support software (CDSS).

The changes will commence on 25 February 2021 and include:

• the exclusion and exemption of certain software-based medical devices from regulation under the medical device regime under the Therapeutic Goods Act;
• the introduction of new classification rules for software-based medical devices (these will impact both existing entries on the Australian Register of Therapeutic Goods (ARTG) and new entries for software-based medical devices); and