— Spotlight on Chinese and foreign medical device regulations; Groundbreaking concepts and materials
SHANGHAI, Aug. 8, 2014 /PRNewswire/ — The Chinese medical device industry is confronted with an era of transformation, which is simultaneously presenting both opportunities and challenges for medical device manufacturers. On September 25-26, the 2014 Medical Device Innovative Technology Forum & Regulation Summit will convene under the theme of "Ramping up MD Development through Regulation & Innovation": providing the latest regulatory updates and advanced technology sharing. The two-day, five-module conference is co-located with the MEDTEC China exhibition at Shanghai World Expo Exhibition & Convention Center.
In 2014, MEDTEC China is expected to attract over 300 leading suppliers to the global medical device industry as well as over 8,000 qualified visitors. Pre-registration is open now for visitors to enjoy free admission.
Getting to grips with the latest Chinese and foreign medical device regulations
In 2013, the FDA officially released regulations for UDI implementation while in 2014, China promulgated the newly revised Medical Device Supervision and Management Regulations. What else should manufacturers keep a watchful eye on and how should they respond to such developments? The answers can be found by attending Module A: Chinese Regulatory Updates and Implementation on September 25 and Module D: Overseas Regulatory Updates and Market Access on the morning of September 26.
The main topics include Updates of Regulations on Supervision and Administration of Medical Devices, Special Approval Process for Innovative Medical Devices by CFDA, High Value Medical Consumables Concentrated Procurement Specification, UDI implementation, FDA updates, US GLP requirements and biological safety evaluation. Senyong Lin, Deputy Director, Medical Equipment Safety Supervision Department of SFDA, and Dr. Zhaohui Li, NAMSA China have been confirmed as speakers.
New design concepts and materials empower device makers
On the afternoon of September 25, another two modules will be held simultaneously – Module B: Design and Innovation of Medical Device & Module C: Application of New Material. These modules will cover many hot topics such as 3D printing, design guidelines for domestic medical equipment in the US, innovation solutions using silicone rubber, high-performance plastics and MIM application.
In these two modules, eminent speakers including Xuebin Zheng, Researcher & Deputy Director, Shanghai Institute of Ceramics, Chinese Academy of Science — laboratory of inorganic coating; Andrea Bogner, Global Medical Marketing Manager, Wacker Chemie; Dane Waund, Healthcare Global Market Manager, Solvay Specialty Polymers; Tina Wei, Global Marketing Director, Momentive Performance Materials; Jingping Peng, General Manager, JING SHENG Medical and Akhiljit Wangkheimayum, Indo-US MIM Tec will share their expertise.
Risk management and quality control ensure the safety
Safety is a key requirement of any medical devices. Module E: risk management and quality control on the morning of September 26 will address the ISO13485 and FDA-QSR820 standards, and how to cooperate with FDA QSIT inspection and CAPA systems.
Meanwhile, at the exhibition area, MEDTEC China will host a Quality Focus Zone, helping Chinese companies to strengthen quality and process control, reduce costs, and improve value. Instron and BOSE have joined this area, and will offer free guidance and training for the visitors.
Conference seats are limited. Please register at your earliest convenience and enjoy a discount. For more information, please go to http://www.medtec-conference.com.
Preshow event- MEDTEC Investment Summit 2014
The day before the show on September 24th, the MEDTEC Investment Summit 2014 will be held to explore enterprises with investment value. Over 25 distinguished speakers from research institutes, commercial enterprises and the finance sector will discuss medical innovation and investment in the future. The detailed agenda can be viewed at http://investing.medtecchina.com.
For more information about the MEDTEC China exhibition and conference, please visit http://www.medtecchina.com.