You are here

regulatory guidance

8 April 2021

The TGA is responsible for the continued safety, quality and performance of medical devices affected by cyber-related issues.

8 April 2021

The following list, which is not exhaustive, contains examples of known cyber security vulnerabilities for medical devices.

  1. Authentication bypass
  2. Buffer overflow
  3. Code injection
  4. Communication protocol vulnerability
  5. Credentials insufficiently
  6. ...
8 April 2021

Pre-market regulatory requirements

Sponsors intending to include a...

8 April 2021

The information provided in this section details the general responsibilities and requirements (for both pre and post market consideration) for medical device manufacturers and sponsors to ensure that devices meet regulatory requirements associated with cyber security, specifically risk...

11 February 2020
Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation
14 September 2020
All FMT products are regulated as biologicals
14 February 2020
Guidance on regulatory requirements for IVD companion diagnostics
10 December 2019
Version history
Version Description of change Author Effective date
V1.0 Original publication


Subscribe to regulatory guidance