Malaysia: Additional Features MeDC@St2.0+ for Change Notification Module
In July 2013, The Medical Device Centralised Online Application System, abbreviated as MeDC@St, was introducedas a system to manage...
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ARQon
Jul 30, 20202 min read
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...
71 views0 comments
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...
119 views0 comments
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...
74 views0 comments
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...
462 views0 comments
ARQon
Aug 24, 20171 min read
Cybersecurity, China ASEAN And MDSAP Updates
Executive Summary: China is Making Additions to its medtech regulatory system, and Southeast Asian nations are making progress towards...
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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
Aug 24, 20172 min read
Drugs - May 2017
Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...
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ARQon
Jul 11, 20171 min read
Vietnam On Track Launching New System, Plus Updates From Bangladesh, Hong Kong
Executive Summary: All eyes are on Vietnam, which is on the threshold of a new regulatory system for medical devices. But the smaller...
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ARQon
Jul 11, 20171 min read
Singapore To Make Major Medtech Regulatory Changes Under Economic Growth Plan
Executive Summary: Regulatory and Market Access Improvements for medtech products were on the agenda at last month's Health Products...
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ARQon
May 31, 20171 min read
HONG KONG: Proposal of Regulation for beauty/aesthetic medical device and Voluntary plan for Class B
The proposal of regulation on medical devices used in the beauty trade has been submitted by the Department of Health (DoH) to Hong...
101 views0 comments
ARQon
Apr 7, 20171 min read
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 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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