Regulatory decisions for medical devices & IVDs
Notices and advice for industry about medical devices & IVDs
The TGA will continue to publish information about medicines and medical devices as it relates to COVID-19 on a regular basis: Coronavirus (COVID-19): Information on medicines and medical devices.
2021 2020 2019 2018
2021
2020
2019
2018
- Reclassification of surgical mesh medical devices
27 November 2018 From 1 December 2018, all new applications for surgical mesh devices (including urogynaecological mesh devices) seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device.
- Update: Increased audit requirements for medical devices using conformity assessment by selected European notified bodies
6 June 2018: TGA no longer considers it necessary to apply increased audit requirements to particular European notified bodies.
- Optimising Class I medical device entries
29 May 2018: Information sheet to assist sponsors to optimise their Class I ARTG listings to minimise the number of entries necessary, while also complying with the therapeutic goods regulatory requirements.
- Revocation of a legislative instrument
26 March 2018: The Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2017 (Order) was registered as a notifiable instrument on the Federal Register of Legislation on 18 August 2017 and commenced the day after registration. The Order declared that 'a material or other article that through chemical means is intended to change, or acts by causing change to, the pH levels of the body fluids, including a body orifice, is not, for the purposes of the Act, a medical device'. On 5 January 2018, a decision was made to revoke the Order. For that purpose, a separate notifiable instrument has now been registered which formally revokes the Order.