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
- 3 min
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
- 2 min
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
- 1 min
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
- 1 min
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, 2020
- 2 min
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, 2020
- 1 min
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, 2019
- 2 min
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, 2019
- 1 min
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, 2019
- 1 min
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, 2019
- 2 min
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, 2019
- 1 min
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, 2019
- 1 min
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, 2019
- 1 min
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, 2019
- 2 min
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, 2018
- 1 min
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, 2018
- 1 min
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, 2018
- 1 min
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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ARQon
- Sep 4, 2018
- 2 min
Asia, Africa & Middle East - Aug/Sep 2018
Australia: 2018 fees and charges released by the Therapeutic Goods Administration Australia: Application fee now charged for a Class I...
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ARQon
- Sep 4, 2018
- 1 min
Drugs - Aug/Sep 2018
International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...
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