English
 
 
 
  China represents an increasing opportunity for sales of high-technology medical devices and diagnostic reagents.  
China is the largest and fastest growing medical device market in Asia
£­£­£­¡¡Population of 1.5 billion
£­£­£­¡¡2003, IVD generated revenues of $700 million
£­£­£­¡¡Annual growth rate in the industry of more than 20%
 
SFDA Requirements:
SFDA requires that most medical devices and IVDs must undergo inspection and testing before registration, and must provide clinical test reports. In some cases, SFDA may require clinical studies to be conducted in China.
 
  Wantai has established and maintains very good relations with several key health care centers such as provincial and capital blood banks and hospitals which have been certified and are able to carry our performance evaluations in accordance with the SFDA requirements.
 
  We are very experienced in organizing and monitoring of clinical evaluations especially in the field of diagnostic tests for infectious diseases. Our Regulatory Department will assure that your performance evaluations will meet the requirements of the SFDA while providing cost effective and time saving planning, study protocols and evaluation management.
 
  What we can offer you:      
       
  Study design and protocol
  Visits to and coordination with the evaluation centers
  Monitoring
  Data management
  Data evaluation and analysis
  Clinical summaries preparation
  Experience ¨C more than 20 small medium and large scale evaluations for domestic and international IVD reagents
 
     
List of SFDA Certified Test Laboratories
 
  Beijing Medical Device Quality Supervision and Inspection Center
Wuhan Medical Device Quality Supervision and Inspection Center
Guangzhou Medical Device Quality Supervision and Inspection Center
Jinan Medical Device Quality Supervision and Inspection Center
Tianjin Medical Device Quality Supervision and Inspection Center
Hangzhou Medical Device Quality Supervision and Inspection Center
Beijing Medical University Medical Device Quality Supervision and Inspection Center
China Institute for the Control of Pharmaceutical and Biological
Products Medical Device Quality Supervision and Inspection Center
Shanghai Medical Device Quality Supervision and Inspection Center
Shenyang Medical Device Quality Supervision and Inspection Center
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