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Asia, Africa & Middle East - February 2018
Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...
ARQon
Feb 2, 20182 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...
ARQon
Jan 1, 20181 min read
Vietnam Decree extended until 31 December 2018
DMEC had a meeting with Vietnam MOH where the 1 year extension of new decree implementation has been approved. The medical device in the...
ARQon
Dec 29, 20171 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...
ARQon
Aug 24, 20172 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...
ARQon
Jul 11, 20171 min read
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....
ARQon
Oct 17, 20161 min read
Registration of medical device will commence in Vietnam from July 2017
Currently only some certain medical devices are registrable. From 1 July 2017, Class B, C, and D medical devices are required to be...
ARQon
Sep 5, 20161 min read
Cessation of import licenses for all foreign medical device
In Vietnam, on 15 May 2016, the Vietnamese Government issued Decree No. 36/2016/ND-CP on medical device management. The Decree took...
ARQon
Jul 31, 20161 min read
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