Australia – Refinements to the Personalised Medical Device Framework
The public consultation indicated the importance of the TGA’s role as the regulator of
medical devices, affirming that in the majority of cases medical devices...
Australia – How to submit a custom-made medical device / patient-matched medical device notification...
The following guide is designed to assist you with completing and submitting a:
• Custom-Made Medical Device (CMMD) notification; and
• Patient-Matched Medical Device (PMMD) transition...
New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
China- Medical Device Administrative Control System (MDACS)
During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device...
Australia – Medical devices vigilance program pilot
The TGA is commencing a new Medical Devices Vigilance Program (MDVP). The MDVP will begin as a 12-month pilot. The pilot is designed to...
Australia – Medical device regulation changes
Changes have been made to the regulation of:
software-based medical devices
prescription spectacle lenses
medical devices containing microbial, recombinant, or animal substances
medical device...
Australia – Understanding personalised medical devices rules (including 3D-printed devices) – Regulatory changes for...
Personalised medical devices are devices that are either designed and manufactured, or modified after they are supplied, to suit an individual.
This document provides information...
Australia – New guidance published on manufacturer evidence for IVD medical devices
We no longer accept ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a...
Australia – Phase out of ISO 13485 certificates for IVD medical devices
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26...
