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 221 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 211 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 173 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 102 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 191 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 151 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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ARQon
Feb 6, 20202 min read
Asia, Africa, Middle East - Jan/Feb 2020
Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD...
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ARQon
Jan 7, 20201 min read
Australia Personalised Medical Device Update
Australia Personalised Medical Device Update The Therapeutic Goods Administration (TGA) made acknowledgement to those who gave a response...
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ARQon
Dec 4, 20192 min read
Asia, Africa & Middle East - Nov/Dec 2019
Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...
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ARQon
Aug 30, 20191 min read
Asia, Africa & Middle East - Aug 2019
Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...
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ARQon
Aug 30, 20191 min read
Drugs - Aug 2019
China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...
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ARQon
Jun 28, 20192 min read
Asia, Africa & Middle East - Jun 2019
Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...
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ARQon
Jun 28, 20191 min read
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
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ARQon
Mar 29, 20191 min read
Asia, Africa & Middle East - Mar 2019
Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...
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ARQon
Mar 29, 20191 min read
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
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ARQon
Mar 28, 20192 min read
Australia TGA Plans for Brexit
The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....
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ARQon
Nov 5, 20181 min read
Asia, Africa & Middle East - Dec 2018
AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...
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ARQon
Nov 5, 20181 min read
Drug - Dec 2018
Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...
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ARQon
Sep 5, 20181 min read
Breaking News: TGA recognises other reference approvals in addition to EU CE for ARTG listing
Australia: Specific evidence and documentation, issued by specific overseas regulators and assessment bodies, will be considered by the...
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