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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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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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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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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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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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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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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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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Apr 2, 20172 min read
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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Dec 6, 20162 min read
More Green Channel Fast Track by China Food and Drug Administration (CFDA)
In late October 2016, ARQon meeting with CFDA on the exchange sharing of fast track authorization route in Singapore and the Green...
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Oct 19, 20161 min read
China FDA clinical trial exemption list just published
Latest China FDA announcement on the Second Batch of Medical Device Exempted from Clinical Investigation CFDA latest announcement on 30...
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Jul 31, 20161 min read
Increase in supervision and management of clinical trials for medical device in China
China Food and Drug Administration (CFDA) and National Health and Family Planning Commission of China (NHFPC) have jointly issued the...
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