Vietnam Officialised Amendments 03/2020/ND-CP to Decree No.36/2016/ND-CP & Decree No.169/2018/ND-CP
Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the...
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ARQon
Dec 23, 20192 min read
Vietnam Further Amendments for Class B on Jan 2021 & Class C and D on Jan 2022
The Vietnamese MOH has released the proposed amendment at the end of 2019 to the Vietnamese medical device industry while waiting for the...
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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
Jun 28, 20191 min read
Asia Reg News: AHWP Catch-up, Korea, Malaysia, Indonesia and Vietnam Updates
Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...
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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
Mar 28, 20191 min read
7th AMDC: ASEAN Borderline and Harmonized Classification documents released
The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...
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ARQon
Mar 28, 20191 min read
ASEAN Updates for Malaysia, Vietnam: Asian Medtech Associations Regulatory Networking
Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...
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ARQon
Dec 11, 20181 min read
Key Endorsements in the 7th AMDC Meeting
The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
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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
Aug 30, 20181 min read
ASEAN - 25th meeting of the Pharmaceutical Product Working Group (PPWG)
ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...
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ARQon
Aug 30, 20181 min read
MEDTECH ASSOCIATIONS REGULATORY NETWORKING - Malaysia, Philippines, Thailand & Vietnam
ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...
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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
Apr 11, 20187 min read
The 6th ASEAN Medical Device Committee (AMDC) Meeting 3-6 April 2018
Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...
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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
Dec 29, 20171 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...
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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
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
Oct 17, 20161 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....
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ARQon
Sep 5, 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...
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