China State Food and Drug Administration Regulations and Product Registration Seminar and Workshop for Medical Devices
30 Aug 2012, 09:00
31 Aug 2012, 17:00
Expand into China's Medical Device Market
SGS is supporting this debut seminar that is jointly organised by Singapore Manufacturer's Federation and DH RegSys Pte Ltd. The seminar will highlight the challenges faced by importers and manufacturers when registering their medical devices in China.
The topics of the seminar includes:
- An overview on the growth of medical devlces globally
- Introduction to medical devices registration
- How to apply the medical device registration
- Introduction of "Regulation on supoervision and management to medical instruments"
- Intoduction of "Measures for the administration of medical device distribution enterprise license'
- Application of medical device distribution enterprise license
Medical device companies who are exploring possibilites to enter China's market should be attending this seminar.
About the speakers
Ms Lee Lai Mei, Business Development Manager, Systems and Services Certification, SGS
Lai Mei is a qualified lead auditor for ISO 13485 Medical Devices Quality Management Systems and Medical Device Directive 93/42/EEC. In addition, she is an approved auditor to conduct audits under Canadian Medical Devices Conformity Assessment System (CMDCAS) and Japanese Pharmaceutical Affairs Law (JPAL). She has close to 20 years of auditing and training experience in the medical devices industry. Lai Mei has also conducted multiple-in-house and public run trainings for ISO 13485 and ISO 14971.
Dr Song Xin Hua, Shanghai Binyan Trade & Agent Co. Ltd.
Dr Song is a very experienced lecturer and consultant on China SFDA regulations on medical devices. In 2000, Dr. Song established his own company, Shanghai Binyan Trade & Agent Co. Ltd. During the last 12 years of operation, his company has successfully assisted more than a hundred Medical Device companies to register their products with China SFDA. Shanghai Binyan Trade & Agent Co. Ltd. is currently listed in the SFDA China Medical Device Information Network as a credible agent. Other positions that Dr. Song has held from 1965 till 1999 are Director of Scientific Research of Hunan Hengyang Medical College (currently known Medical School of Nanhua University) as well as President of the First Affiliated Hospital, Representative Office Manager in Shanghai for Hong Kong Keli Co. Ltd., China Advisor for HAKUJU Scientific Institute of Japan, just to name a few.