Sign up | Log in



Home  >>   Daily News  >>   Asean News  >> Infrastructure  >> Improving ASEAN Healthcare Through Medical Device Regulation Harmonization

NEWS UPDATES Asean Affairs   3 May 2013  

Improving ASEAN Healthcare Through Medical Device Regulation Harmonization

As ASEAN moves towards the ASEAN Economic Community (AEC) in 2015, healthcare remains a high priority sector to be integrated across the region and vital to successful integration of the sector is the harmonization and efficiency of its regulations. To boost the capability of ASEAN medical device regulators and the medical device industry, over 40 ASEAN medical device regulators met in Malaysia last week at the Medical Devices Regulatory Harmonization Training Program.

The workshop is the first of a multi-year medical devices training program for ASEAN that will ensure ongoing improvement in the understanding and interpretation of the ASEAN Medical Device Directive (AMDD). The AMDD requires ASEAN countries to implement standardized medical device classification criteria and device placement systems, and to establish post-marketing surveillance alert systems. The Medical Device Product Working Group (MDPWG), which is one of 11 bodies of the ASEAN Consultative Committee for Standards and Quality (ACCSQ), developed the draft AMDD.

“The AMDD will help reduce red tape and boost the efficiency of trade in medical devices in the region,” said Matthew Hein of the US Department of Commerce.  “It will clarify and delineate the many roles and responsibilities held by regulators in bringing and keeping medical devices in the marketplace and it will not only make the role of regulators more straightforward, it will bring the people of ASEAN improved access to medical technologies.”

Topics covered in the workshop included a big-picture overview, product life cycles, roles and responsibilities of regulatory authorities, the definition of a medical device, risk management, conformity assessment, listing and registration of devices, and post-market surveillance to provide regulators rapid identification of defective or unsafe devices.

“The training program is aimed at high-level ASEAN medical device regulators,” said Michael Flood, a former senior official in Australia’s Therapeutic Goods Administration with over 30 years of experience working with medical devices. Mr Flood, responsible in the development of the ASEAN medical device training curriculum, added that “we expect feedback from this meeting will help guide us in selecting areas of the syllabus to give greater focus to in future ASEAN-wide training programs.”

Following the implementation of the AMDD, uniform systems and regulations that come with the directive are expected to help improve patient safety standards across the region as well as providing a more straightforward path to market in the region for manufacturers of medical devices.

“Successful introduction and implementation of the AMDD will require regulatory agencies of each of the ASEAN Member States to have a thorough understanding of both the underlying philosophies of the Global Harmonization Task Force and the basic building blocks which, when integrated, provide a robust and adaptable framework aimed at ensuring citizens of each of the ASEAN Member States have timely access to safe and effective medical devices. This series of training will help ASEAN medical device regulators forge a common understanding and interpretation of the provisions of the AMDD,” said Mr. Zamane Abdul Rahman, Chairman of the MDPWG.

The U.S. Government-funded ASEAN-U.S. Technical Assistance and Training Facility in collaboration with the Ministry of Health of Malaysia and the ASEAN Secretariat organised the Medical Devices Regulatory Harmonization Training Program on 22-23 April 2013 in Petaling Jaya, Selangor, Malaysia.

Reach Southeast Asia!
10- Nations, 560- Million Consumers
And $1 -Trillion Market
We are the Voice of Southeast Asia Media Kit
The only Media Dedicated to Southeast Asia Advertising Rates for Magazine
Online Ad Rates

Comment on this Article. Send them to

Letters that do not contain full contact information cannot be published.
Letters become the property of AseanAffairs and may be republished in any format.
They typically run 150 words or less and may be edited
submit your comment in the box below

Today's  Stories    3 May 2013 Subsribe Now !
• Thai bourse awards winners of capital market learning center concept contest Subcribe: Asean Affairs Global Magazine
• Norway adds 10 new scholarships for Myanmar students to study at AIT in 2013 Asean Affairs Premium
• AirAsia Introduces New Energy Drink On Board
• Thai bourse lists KPNPF property fund on May 3
Research Reports
on Thailand 2007-2008

•Textiles and Garments Industry

•Coffee industry

•Leather and footwear industry

•Shrimp industry

• AirAsia X Records 20.9% Growth in First Quarter 2013
• MAS Consults on Proposed Regulatory Requirements for Renminbi (RMB) Foreign Exchange Conversion in China
• Vietnamese consumers spent nearly USD1.14 billion on 3.5 million units of air-conditioners
• Thai Fest in Tokyo 2013 is ready to amaze the visitors
• ASEAN-Japan Enhance Further Cooperation in Information and Communication Technology
• Improving ASEAN Healthcare Through Medical Device Regulation Harmonization
• ASEAN is a Priority in Canada’s Foreign Policy
• Germany to expand investments in Manila
Asean Analysis            3 May 2013 Advertise Your Brand
• Asean Analysis- May 3, 2013  
• Asean Weekly- May 3, 2013 Sponsor Our Events
Asean Stock Watch     3 May 2013
• Asean Stock Watch-May 3, 2013  
• Asean Stock Watch-May 2, 2013  

ASEAN NEWS UPDATES      Updated: 04 January 2011

 • Women Shariah scholars see gender gap closing
• Bank Indonesia may hold key rate as inflation hits 7 percent
• Bursa Malaysia to revamp business rules
• Private property prices hit new high in Singapore • Bangkok moves on mass transport
• Thai retailers are upbeat
• Rice exports likely to decline • Vietnamese PM projects 10-year socioeconomic plan


This year in Thailand-what next?

AseanAffairs   04 January 2011
By David Swartzentruber      

It is commonplace in journalism to write two types of articles at the transition point between the year that has passed and the New Year. As this writer qualifies as an “old hand” in observing Thailand with a track record dating back 14 years, it is time take a shot at what may unfold in Thailand in 2011.

The first issue that can’t be answered is the health of Thailand’s beloved King Bhumibol, who is now 83 years old. He is the world's longest reigning monarch, but elaborate birthday celebrations in December failed to mask concern over his health. More






1.  Verifier

1. Verifier

For security purposes, we ask that you enter the security code that is shown in the graphic. Please enter the code exactly as it is shown in the graphic.
Your Code
Enter Code

Home | About Us | Contact Us | Special Feature | Features | News | Magazine | Events | TV | Press Release | Advertise With us

| Terms of Use | Site Map | Privacy Policy  | DISCLAIMER |

Version 5.0
Copyright © 2006-2020 TIME INTERNATIONAL MANAGEMENT ENTERPRISES CO., LTD. All rights reserved.
Bangkok, Thailand