The TGA accepted MMDR recommendation 21 to set timeframes that reflect worldwide benchmarks and the standard lifecycle of a medical device for evaluation and inclusion in the Australian Register of Therapeutic Goods (ARTG).Australia\’s regulatory framework for therapeutic goods is undergoing a number changes in response to the MMDR.
In 2019, an independent reviewer compared the TGA\’s processes and timeframes towards worldwide regulators, including the USA, Canada, Japan, Brazil and the European Union. Overall ,it became difficult to evaluate them due to the differences between regulatory systems. A Review of Medicines and Medical Devices Regulation (MMDR) was undertaken from 2014–15 to pick out areas of unnecessary, duplicative, or ineffective regulation that could be streamlined and opportunities to enhance the regulatory framework, in order that Australia remain properly placed to respond to emerging global trends. The Government accepted 56 recommendations that provide options to harmonise Australia’s regulatory system for therapeutic products with international regulatory frameworks and allow for greater flexibility in approval pathways for medicines and medical devices.
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Recommendation 21 of the MMDR evaluation suggested that the Therapeutic Goods Administration ( TGA ) set up target timeframes that reflect worldwide benchmarks and the typical lifecycle of a medical device for:
- Conformity check conducted by means of the TGA (referred to as pre-market approval); and
- Suggestions about inclusion of a device in the Australian Therapeutic Goods Register (ARTG) following submission of an application for inclusion (referred to as market authorisation) where: – the TGA has undertaken conformity assessment – a comparable overseas body has undertaken conformity assessment and a full evaluation report and dossier have been provided to the TGA.
The Australian medical devices regulatory framework is based on the principles of medical device regulation developed by the Global Harmonization Task Force (GHTF).
The TGA processing times for conformity evaluation programs for inclusion on the ARTG are calculated using the TGA half-yearly overall performance snapshot 2 July to 31 December 2021.
From October 2020, changes had been made to align the inclusion process for Class I medical device applications with other medical device applications This means that an assessment will be undertaken to ensure the requirements for inclusion have been met, and where necessary an application may be selected for audit.
Timeframes for inclusion on the ARTG are as below:
| Medical devices | Time |
| Class I without audit | 3 days |
| Class I with audit | 31 days |
| Non- Class I without audit | 10 days |
| Non- Class I | 115 days |
| Level 1 compulsory Audit | 27 days |
| Level 2 compulsory Audit | 174 days |
| Conformity Assessment | 137 Days |
| IVDs | Time |
| Class I IVD without audit | 2 days |
| Class I IVD with audit | 9 days |
| Non- Class I IVD without audit | 5 days |
| IVD Non -compulsory Audit | 41 days |
| IVD compulsory Audit | 64 days |
If you are doing business in Australian market or if you have a plan to enter into the Australian medical device market you must know the regulatory updates from TGA .
References:
https://www.tga.gov.au/medical-device-application-processing-times
