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.
澳大利亚医疗设备监管框架基于全球协调工作组（GHTF）开发的医疗设备监管原理。
使用TGA ARTG的TGA处理时间使用TGA半年度整体绩效快照计算，并于2021年12月31日进行计算。
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:
| 医疗设备 | Time |
| Class I without audit | 3天 |
| I级审核 | 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天 |
| IVDs | Time |
| Class I IVD without audit | 2 days |
| Class I IVD with audit | 9天 |
| Non-Class I IVD without audit | 5天 |
| IVD Non -compulsory Audit | 41 days |
| IVD compulsory Audit | 64 days |
如果你在澳大利亚做生意market or if you have a plan to enter into the Australian medical device market you must know the regulatory updates from TGA .
参考：
https://www.tga.gov.au/medical-device-application-processing-times
