Asia, Africa and the Middle East - May 2020
Australia: Consultation on scope of regulated software-based products Bangladesh: New rules proposed for WEEE and RoHS that will affect...
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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
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
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
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
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
Sep 4, 20182 min read
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
May 23, 20182 min read
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, 20182 min read
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, 20181 min read
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
Aug 24, 20172 min read
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 6, 20171 min read
Asia, Africa & Middle East - April 2017
Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP Australia: Regulatory reform consultations Australia: MTAA...
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ARQon
Sep 2, 20161 min read
Full compliance for GS1 will be required soon
According to the Saudi FDA, full compliance with GS1 data carriers on pharmaceutical products is required by March 2017. This includes...
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