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
- 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
- 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
- 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 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
- 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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ARQon
- Aug 24, 2017
- 2 min
Asia, Africa & Middle East - May 2017
Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016 Australia: Consultation held on future regulation of low risk...
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ARQon
- Apr 7, 2017
- 1 min
Impact of recent changes to Japan’s medical device regulations: a Competent Authority perspective -
Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,...
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ARQon
- Apr 2, 2017
- 2 min
Updates on Drugs - April 2017
Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...
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ARQon
- Oct 17, 2016
- 1 min
Vietnam Decree, Malaysia Labels and More
Vietnam's Decree on Management of Medical Devices (No. 36/2016/ND-CP) is coming soon - probably sooner than expected for the unprepared....
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