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ARQon
Dec 18, 20242 min read
Australia: TGA Updates Labeling Requirements and Guidelines for Injectable Medicines
The Therapeutic Goods Administration (TGA) has announced updates to the labeling requirements and guidelines for injectable electrolyte...
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ARQon
Nov 26, 20242 min read
Australia: Key Deadlines for Patient-Matched Medical Devices (PMDDs)
The Therapeutics Goods Administration (TGA) has established a transition period to facilitate smooth transitions and allows continued...
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ARQon
Oct 22, 20241 min read
Australia: Critical Challenge for Medical Devices Due to 3G Network Shutdown
Starting on 28 October 2024 , both Telstra and Optus will be shutting down their third-generation (3G) networks. This follows the earlier...
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ARQon
Aug 21, 20241 min read
Australia: Prescription Lenses and Their Exemption from Medical Device Classification (15 June 2024)
Compliance effective on 15 June 2024 , prescription lenses for refractive correction are exempted from the requirement for inclusion in...
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ARQon
Jul 17, 20243 min read
Australia: Navigating New Regulation Changes for Medical Devices
The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....
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ARQon
Jul 10, 20242 min read
Australia: New Vaping Legislation Effective from 1 July 2024
Australia introduces new legislation, The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, to regulate the...
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ARQon
Jun 19, 20241 min read
Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)
On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination...
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ARQon
May 15, 20241 min read
Australia: TGA Adopts 2021 Sunscreen Standard (w.e.f 1 July 2024)
Starting 1 July 2024, the Therapeutic Goods Administration (TGA) will adopt the 2021 Sunscreen Standard (Australian/New Zealand Standard...
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