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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ARQon
- Aug 30, 2018
- 2 min
Fees increase after years in Singapore HSA & Philippines FDA, and yearly approach increase by US
Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...
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ARQon
- May 23, 2018
- 2 min
Asia, Africa & Middle East - May 2018
Australia: Changes to the therapeutic goods advertising framework Australia: Guidance on updating an existing Class 1–3 in-house IVD...
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ARQon
- Feb 2, 2018
- 2 min
Asia, Africa & Middle East - February 2018
Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...
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ARQon
- Jan 1, 2018
- 1 min
Asia, Africa & Middle East - December 2017
Australia: Articles that alter the pH of body fluids are not medical devices Australia: Up-classification of surgical mesh and provision...
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ARQon
- Nov 1, 2017
- 2 min
Drugs - October 2017
US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...
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