Apr 26, 2022
Australia’s Therapeutic Goods Administration (TGA) has published Medical device application processing times, which provides details on its latest timelines for medical device and in vitro diagnostic (IVD) device applications and conformity assessments. The revised time estimates were established in response to the Review of Medicines and Medical Devices Regulation (MMDR).
The TGA accepted MMDR recommendation 21 to set target timeframes that reflect international benchmarks and the typical lifecycle of a medical device for assessment and inclusion in the Australian Register of Therapeutic Goods (ARTG).
Based on the TGA Half-Yearly Performance Snapshot from July 2 to December 31, 2021, the TGA's latest mean processing times (in business days) are as follows:
Medical devices
- Class I applications without audit - 3 days
- Class I applications with audit - 31 days
- Non-Class-I applications without audit - 10 days
- Non-mandatory audits (non-class I) - 115 days
- Level 1 mandatory audits - 27 days
- Level 2 mandatory audits - 174 days
- Conformity assessment - 137 days
IVDs
- Class 1 applications without audit - 2 days
- Class 1 applications with audit - 9 days
- Non-Class-1 applications without audit - 5 days
- Non-mandatory audits - 41 days
- Mandatory audits - 64 days
- Conformity assessment - 152 days
As previously reported by Emergo by UL, medical device applications and conformity assessment timelines can vary based upon the risk of the medical device. Generally, the higher the risk of the device, the longer it takes to provide a thorough evaluation of its safety and effectiveness.
Learn more about Australia TGA medical device regulatory requirements at Emergo by UL:
- Australia TGA medical device registration and approval consulting
- Australia TGA Sponsor in-country representation
- Whitepaper: Medical device registration in Australia and New Zealand
Author
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Kathryn Burke
