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 17, 20181 min read
Malaysia MDA Announces Medcert 2.0 and Email & Website Changes
With effective as of 2 January 2019, Medical Devices Authority will make the following changes: Malaysia MDA also recently introduced 2...
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ARQon
Dec 17, 20181 min read
Malaysia Unregistered Route for Export-Only & Diagnostics-Only Devices
MDA shed the light on the following statistics: Total establishment license: 2,300 Establishments; Manufacturers: 230 Authorized...
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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 5, 20181 min read
Malaysia rejects pending applications exceeding 6 months and releases clarification on export device
Malaysia: MDA has released a recent announcement on the full enforcement of the need to register medical devices under section 5 of 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
MDA Registration number & Labelling requirements with 3 years transition
Malaysia: The Medical Device Authority has decided for implementation of an additional 3 year transition period for establishments to...
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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
Cosmetic, Drug or Device? MDA and NPRA shed the light on the product demarcation for combination and
Malaysia: Medical Device-Drug-Cosmetic Interphase (MDDCI) Products are those products that are not clearly defined as a medical device or...
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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...
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ARQon
Dec 31, 20171 min read
Malaysia extension for manufacturer to submit registration supporting document and validity of ackno
Refering to the announcement issued by the Medical Devices Authority (PBPP) regarding the full enforcement of medical device registration...
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ARQon
Aug 24, 20171 min read
MEDTECH ASSOCIATIONS REGULATORY NETWORKING, July 2017 - Singapore, the Philippines, Myanmar
THE FIRST MEDTECH ASSOCIATIONS REGULATORY NETWORKING discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy...
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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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