Click here to close now.

Welcome!

.NET Authors: Pat Romanski, Elizabeth White, Andreas Grabner, Tad Anderson, Gregor Petri

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
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., showed what is needed to leverage the IoT to transform your business. He discussed opportunities and challenges ahead for the IoT from a market and technical point of vie...
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS solutions that provide a Hadoop flavor either make choices for customers very flexible in the name of opti...
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impact.
Advanced Persistent Threats (APTs) are increasing at an unprecedented rate. The threat landscape of today is drastically different than just a few years ago. Attacks are much more organized and sophisticated. They are harder to detect and even harder to anticipate. In the foreseeable future it's going to get a whole lot harder. Everything you know today will change. Keeping up with this changing landscape is already a daunting task. Your organization needs to use the latest tools, methods and expertise to guard against those threats. But will that be enough? In the foreseeable future attacks w...
Disruptive macro trends in technology are impacting and dramatically changing the "art of the possible" relative to supply chain management practices through the innovative use of IoT, cloud, machine learning and Big Data to enable connected ecosystems of engagement. Enterprise informatics can now move beyond point solutions that merely monitor the past and implement integrated enterprise fabrics that enable end-to-end supply chain visibility to improve customer service delivery and optimize supplier management. Learn about enterprise architecture strategies for designing connected systems tha...
Wearable devices have come of age. The primary applications of wearables so far have been "the Quantified Self" or the tracking of one's fitness and health status. We propose the evolution of wearables into social and emotional communication devices. Our BE(tm) sensor uses light to visualize the skin conductance response. Our sensors are very inexpensive and can be massively distributed to audiences or groups of any size, in order to gauge reactions to performances, video, or any kind of presentation. In her session at @ThingsExpo, Jocelyn Scheirer, CEO & Founder of Bionolux, will discuss ho...
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along with a steady stream of well-publicized data breaches, only add to the uncertainty
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing demand and the rapidly changing workspace model.
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
As organizations shift toward IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection &E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 16th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships, will discuss how to cut costs, scale easily, and unleash insight with CommVault Simpana software, the only si...
Cloud data governance was previously an avoided function when cloud deployments were relatively small. With the rapid adoption in public cloud – both rogue and sanctioned, it’s not uncommon to find regulated data dumped into public cloud and unprotected. This is why enterprises and cloud providers alike need to embrace a cloud data governance function and map policies, processes and technology controls accordingly. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems, will focus on how to set up a cloud data governance program and s...
Roberto Medrano, Executive Vice President at SOA Software, had reached 30,000 page views on his home page - http://RobertoMedrano.SYS-CON.com/ - on the SYS-CON family of online magazines, which includes Cloud Computing Journal, Internet of Things Journal, Big Data Journal, and SOA World Magazine. He is a recognized executive in the information technology fields of SOA, internet security, governance, and compliance. He has extensive experience with both start-ups and large companies, having been involved at the beginning of four IT industries: EDA, Open Systems, Computer Security and now SOA.
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focused on understanding how industrial data can create intelligence for industrial operations. Imagine ...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, representing a model of how to analyze rea...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
HP and Aruba Networks on Monday announced a definitive agreement for HP to acquire Aruba, a provider of next-generation network access solutions for the mobile enterprise, for $24.67 per share in cash. The equity value of the transaction is approximately $3.0 billion, and net of cash and debt approximately $2.7 billion. Both companies' boards of directors have approved the deal. "Enterprises are facing a mobile-first world and are looking for solutions that help them transition legacy investments to the new style of IT," said Meg Whitman, Chairman, President and Chief Executive Officer of HP...
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
PubNub on Monday has announced that it is partnering with IBM to bring its sophisticated real-time data streaming and messaging capabilities to Bluemix, IBM’s cloud development platform. “Today’s app and connected devices require an always-on connection, but building a secure, scalable solution from the ground up is time consuming, resource intensive, and error-prone,” said Todd Greene, CEO of PubNub. “PubNub enables web, mobile and IoT developers building apps on IBM Bluemix to quickly add scalable realtime functionality with minimal effort and cost.”