Click here to close now.


Microsoft Cloud Authors: Jayaram Krishnaswamy, Elizabeth White, Andreas Grabner, Jim Kaskade, Pat Romanski

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
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in high-performance, high-efficiency server, storage technology and green computing, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and Embedded Systems worldwide. Supermi...
Nowadays, a large number of sensors and devices are connected to the network. Leading-edge IoT technologies integrate various types of sensor data to create a new value for several business decision scenarios. The transparent cloud is a model of a new IoT emergence service platform. Many service providers store and access various types of sensor data in order to create and find out new business values by integrating such data.
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
There are so many tools and techniques for data analytics that even for a data scientist the choices, possible systems, and even the types of data can be daunting. In his session at @ThingsExpo, Chris Harrold, Global CTO for Big Data Solutions for EMC Corporation, will show how to perform a simple, but meaningful analysis of social sentiment data using freely available tools that take only minutes to download and install. Participants will get the download information, scripts, and complete end-to-end walkthrough of the analysis from start to finish. Participants will also be given the pract...
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, will introduce the technologies required for implementing these ideas and some early experiments performed in the Kurento open source software community in areas ...
Electric power utilities face relentless pressure on their financial performance, and reducing distribution grid losses is one of the last untapped opportunities to meet their business goals. Combining IoT-enabled sensors and cloud-based data analytics, utilities now are able to find, quantify and reduce losses faster – and with a smaller IT footprint. Solutions exist using Internet-enabled sensors deployed temporarily at strategic locations within the distribution grid to measure actual line loads.
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, will explore the current state of IoT connectivity and review key trends and technology requirements that will drive the Internet of Things from hype to reality.
There will be 20 billion IoT devices connected to the Internet soon. What if we could control these devices with our voice, mind, or gestures? What if we could teach these devices how to talk to each other? What if these devices could learn how to interact with us (and each other) to make our lives better? What if Jarvis was real? How can I gain these super powers? In his session at 17th Cloud Expo, Chris Matthieu, co-founder and CTO of Octoblu, will show you!
Today’s connected world is moving from devices towards things, what this means is that by using increasingly low cost sensors embedded in devices we can create many new use cases. These span across use cases in cities, vehicles, home, offices, factories, retail environments, worksites, health, logistics, and health. These use cases rely on ubiquitous connectivity and generate massive amounts of data at scale. These technologies enable new business opportunities, ways to optimize and automate, along with new ways to engage with users.
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes about through a Communications Platform as a Service which allows for messaging, screen sharing, video...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal an...
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
SYS-CON Events announced today that Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, will keynote at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data shows "less than 10 percent of IoT developers are making enough to support a reasonably sized team....
As a company adopts a DevOps approach to software development, what are key things that both the Dev and Ops side of the business must keep in mind to ensure effective continuous delivery? In his session at DevOps Summit, Mark Hydar, Head of DevOps, Ericsson TV Platforms, will share best practices and provide helpful tips for Ops teams to adopt an open line of communication with the development side of the house to ensure success between the two sides.
The IoT market is on track to hit $7.1 trillion in 2020. The reality is that only a handful of companies are ready for this massive demand. There are a lot of barriers, paint points, traps, and hidden roadblocks. How can we deal with these issues and challenges? The paradigm has changed. Old-style ad-hoc trial-and-error ways will certainly lead you to the dead end. What is mandatory is an overarching and adaptive approach to effectively handle the rapid changes and exponential growth.
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi's VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driving this change including privacy controls, data transparency and integration of real time context w...