Welcome!

Microsoft Cloud Authors: Pat Romanski, Lori MacVittie, Andreas Grabner, Jim Kaskade, John Basso

News Feed Item

International Medical Device Conference in Taiwan Sets Three Records

The biggest event ever in Taiwan's medical device regulatory conference

TAIPEI, Taiwan, Nov. 5, 2012 /PRNewswire/ -- Taiwan Food and Drug Administration, Department of Health, Executive Yuan is hosting a series of international events on medical devices from the 2nd of November to the 8th of November. Events include the "17th Asian Harmonization Working Party Annual Conference", "2012 APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products" and "2012 APEC Advanced Workshop of Good Review Practice on Medical Products". Taiwan's medical device industry has been booming in recent years and the Executive Yuan has included medical devices as one of the key areas of development for the domestic biotechnology industry. The Executive Yuan seeks to enhance the global competitiveness of domestic manufacturers and help the domestic industry actively gain a foothold in the global market with its "Taiwan Biotech Take-off Diamond Action Plan" for the biotechnology industry. In response to the global harmonization of medical device regulation, Taiwan Food and Drug Administration (TFDA) has been building a regulatory environment for medical devices that is in line with international standards. It participates actively in the international harmonization organizations for medical device regulation and seeks to host large-scale international conferences to promote transnational integration of resources and the exchange of experiences. Up to now, there have been over 400 attendees coming from 27 countries. The series of events to be held will set three records in Taiwan's medical device industry -- the largest number of participating countries, the largest number of participating officers from regulatory authorities around the world and the largest number of registration from foreign attendees. This brings immense honor to the Division of Medical Devices and Cosmetics at the TFDA. The division is in charge of the administration of industry regulations on medical devices in Taiwan as well as organization of the events.

Key participants of the events include Mr. Mike Ward, chairman of the APEC Regulatory Harmonization Steering Committee (RHSC) and Manager of International Programs Division at Health Canada, Dr. Saleh S Al Tayyar, chairman of the Asian Harmonization Working Party (AHWP), Mr. Jeffrey Gren, director of the Office of Health and Consumer Goods, International Trade Administration, U.S. Department of Commerce, Mr. Laurent Selles, head of the Cosmetics and Medical Devices Unit, Directorate-General Health and Consumers, European Commission, Mrs. Elizabeth Baker from Medicine and Healthcare Products Regulatory Agency, UK, Mr. Kentaro Azuma from Japan's Ministry of Health, Labour and Welfare, Mrs. Joanna Koh from Health Sciences Authority, Singapore, Mr. Guobiao Gao from the State Food and Drug Administration (SFDA) of the People's Republic of China, and other representatives of regulatory authorities on medical devices from various countries and regions. Dr. San-Cheng Chang, Minister without Portfolio from Taiwan's Executive Yuan, Dr. Huihua Chiang, executive secretary of the Office of Science and Technology of Taiwan's Executive Yuan and Wen-Ta Chiu, Minister of Department of Health will also be gracing the events.

Industry representatives who will be attending the events include Dr. Brian Snyder and Dr. Kulwant Saini, vice presidents of Johnson & Johnson Asia Pacific, Mr. Michael Gropp and Dr. Geraldine Finn, vice presidents of Medtronic from the US, Mr. Arthur Brandwood, CEO of Brandwood Biomedical from Australia and Ms. Siriphan Emrungroj, senior consultant at Thai Medical Device Technology Industry Association.

In addition to discussions on the progress of work of AHWP's policy and technical committee, the events will also see invited representatives of health authorities from various countries, representatives of international medical device organizations and industry experts assuming the role of trainers/lecturers on industry regulations. They will discuss clinical assessment, quality management systems, regulatory control of listed companies, medical device software control and other topics. They will also conduct a workshop in conjunction with APEC on medical device combination products. Advanced courses will also be conducted on the standards for review operations. This series of event will be one of the most important international events on medical device regulations in Asia in 2012. By participating in the activities, industry participants from Taiwan can interact with representatives of regulatory authorities and medical device entrepreneurs from around the world and establish channels of communication with respect to industry regulations, as well as promote global R&D manufacturing and marketing cooperation.

AHWP, a voluntary nonprofit organization, comprises of representatives of regulatory authorities and industry experts from 23 member countries across Asia, Arab states of the Persian Gulf and South America. It seeks to study and put forward ways to harmonize laws and regulations on medical devices in Asia and work with international organizations such as the Global Harmonization Task Force (GHTF) and Asia-Pacific Economic Cooperation (APEC) to develop regulatory requirements, procedures and standards on medical devices, to promote harmonization of global laws and regulations on medical devices.

Established in 2002, the APEC Life Sciences Innovation Forum (LSIF) comprises of representatives of regulatory authorities and industry experts from 21 member countries in the Asia Pacific region. It seeks to bring together government and industry representatives and academia in member countries to jointly promote life sciences innovation so as to support human health in the Asia-Pacific region.

An organization under the APEC LSIF, the APEC Harmonization Center (AHC) mainly promotes the harmonization of pharmaceutical regulations and it has successfully conducted activities, discussions and training courses on 11 related laws and regulations for products.

While TFDA works closely with international organizations such as APEC and AHWP toward global harmonization of medical device regulation, it is also making consumer centered regulatory reforms, domestically, to better ensure medical device safety and efficacy.  Since its establishment, TFDA has always served as the 'gate-keeper' for medical device users, emphasizing on premarket evaluation. However, TFDA is taking a new direction to speed up pre-market evaluation and accelerate product to market timeframe, while enhancing post-market regulations. The implementation of Summary Technical Documentation (STED) and Good Review Practice (GRP) will help shorten the time for pre-market review, while plans to construct Total Product Life Cycle (TPLC) of the medical devices, strengthen and enhance illegal medical device inspection and reinforce post-market surveillance. To further ensure medical device safety and efficacy, TFDA has adopted ISO 13485: 2003 and started to establish risk-based inspection system to determine the priority and frequency of the quality system inspection of manufacturers.  Lastly, regulation on the distributor will also be implemented through the establishment of Good Distributor Practice (GDP) to ensure the consistency of medical device quality.  These reforms will not only allow better regulatory efficiency, but most importantly, better protect the health of medical device users.

The international conference and workshops will also promote the harmonization of their medical device management systems with the rest of the world and help participants of the biomedical industry gain an understanding of the laws, regulations and supervisory requirements of various countries, so that they are in a better position to overcome obstacles in other countries in terms of technical documents. They will help industry players in Taiwan explore the global market and market their brands throughout the world.

Media Contact:

Grace Chao
Tel: +886-932-068-081 / +886-2-2708-2678-13
Email: [email protected]

SOURCE Department of Health, Executive Yuan, Taiwan

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
In addition to all the benefits, IoT is also bringing new kind of customer experience challenges - cars that unlock themselves, thermostats turning houses into saunas and baby video monitors broadcasting over the internet. This list can only increase because while IoT services should be intuitive and simple to use, the delivery ecosystem is a myriad of potential problems as IoT explodes complexity. So finding a performance issue is like finding the proverbial needle in the haystack.
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band-aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It does...
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...