|By PR Newswire||
|November 5, 2012 12:00 AM EST||
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.
Tel: +886-932-068-081 / +886-2-2708-2678-13
Email: [email protected]
SOURCE Department of Health, Executive Yuan, Taiwan
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Jul. 26, 2016 03:15 PM EDT Reads: 276
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Jul. 26, 2016 03:15 PM EDT Reads: 900
Verizon Communications Inc. (NYSE, Nasdaq: VZ) and Yahoo! Inc. (Nasdaq: YHOO) have entered into a definitive agreement under which Verizon will acquire Yahoo's operating business for approximately $4.83 billion in cash, subject to customary closing adjustments. Yahoo informs, connects and entertains a global audience of more than 1 billion monthly active users** -- including 600 million monthly active mobile users*** through its search, communications and digital content products. Yahoo also co...
Jul. 26, 2016 02:30 PM EDT Reads: 477
"There's a growing demand from users for things to be faster. When you think about all the transactions or interactions users will have with your product and everything that is between those transactions and interactions - what drives us at Catchpoint Systems is the idea to measure that and to analyze it," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York Ci...
Jul. 26, 2016 01:45 PM EDT Reads: 1,991
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Jul. 26, 2016 10:15 AM EDT Reads: 1,184
Is your aging software platform suffering from technical debt while the market changes and demands new solutions at a faster clip? It’s a bold move, but you might consider walking away from your core platform and starting fresh. ReadyTalk did exactly that. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, will discuss why and how ReadyTalk diverted from healthy revenue and over a decade of audio conferencing product development to start an innovati...
Jul. 26, 2016 09:15 AM EDT Reads: 1,016
It’s 2016: buildings are smart, connected and the IoT is fundamentally altering how control and operating systems work and speak to each other. Platforms across the enterprise are networked via inexpensive sensors to collect massive amounts of data for analytics, information management, and insights that can be used to continuously improve operations. In his session at @ThingsExpo, Brian Chemel, Co-Founder and CTO of Digital Lumens, will explore: The benefits sensor-networked systems bring to ...
Jul. 26, 2016 08:45 AM EDT Reads: 1,541
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Jul. 26, 2016 08:45 AM EDT Reads: 619
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
Jul. 26, 2016 08:45 AM EDT Reads: 1,319
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
Jul. 26, 2016 06:15 AM EDT Reads: 1,434
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2016 Silicon Valley. The 19th Cloud Expo and 6th @ThingsExpo will take place on November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Interne...
Jul. 26, 2016 05:15 AM EDT Reads: 2,121
Large scale deployments present unique planning challenges, system commissioning hurdles between IT and OT and demand careful system hand-off orchestration. In his session at @ThingsExpo, Jeff Smith, Senior Director and a founding member of Incenergy, will discuss some of the key tactics to ensure delivery success based on his experience of the last two years deploying Industrial IoT systems across four continents.
Jul. 26, 2016 05:00 AM EDT Reads: 1,539
CenturyLink has announced that application server solutions from GENBAND are now available as part of CenturyLink’s Networx contracts. The General Services Administration (GSA)’s Networx program includes the largest telecommunications contract vehicles ever awarded by the federal government. CenturyLink recently secured an extension through spring 2020 of its offerings available to federal government agencies via GSA’s Networx Universal and Enterprise contracts. GENBAND’s EXPERiUS™ Application...
Jul. 26, 2016 03:45 AM EDT Reads: 1,849
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develo...
Jul. 26, 2016 02:00 AM EDT Reads: 1,380
SYS-CON Events announced today that MangoApps will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device.
Jul. 26, 2016 01:45 AM EDT Reads: 1,334
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, explained how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
Jul. 26, 2016 01:30 AM EDT Reads: 1,031
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, 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 opportuni...
Jul. 26, 2016 01:15 AM EDT Reads: 2,553
In today's uber-connected, consumer-centric, cloud-enabled, insights-driven, multi-device, global world, the focus of solutions has shifted from the product that is sold to the person who is buying the product or service. Enterprises have rebranded their business around the consumers of their products. The buyer is the person and the focus is not on the offering. The person is connected through multiple devices, wearables, at home, on the road, and in multiple locations, sometimes simultaneously...
Jul. 26, 2016 12:45 AM EDT Reads: 696
“delaPlex Software provides software outsourcing services. We have a hybrid model where we have onshore developers and project managers that we can place anywhere in the U.S. or in Europe,” explained Manish Sachdeva, CEO at delaPlex Software, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 26, 2016 12:00 AM EDT Reads: 1,559
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Jul. 25, 2016 11:15 PM EDT Reads: 2,030