We are a professional service company to provide Chinese regulatory information and relevant management service concentrating on the Chinese medical and health field on the basis of the Medical Devices (MD) and in vitro diagnostics (IVD) industry. The client of our services is the domestic and oversea corporations, organizations as well as individuals related to Chinese medical and health who do business in the Mainland of China or wish to enter the Mainland of China.

        Our services are through a convenient and safe network or the form of face-to-face to provide bilingual services of English and Chinese. The categories of our services are mainly Regulatory Affairs (RA) Service, Management Service and Broker Service.

        We not only have a professional team comprised the professionals from Medical and Health Science and Industry, Service Management and Information Technology, but also have the unique "Step-by-Step Standardized Service" (SbSS) tool and "Three-Dimensional Mutual Control" (3DMC) management mechanism to monitor and control service process and promote service improvement and development, so as to ensure the quality of our services and satisfy our client demands continuously.
    Hot point 
 CFDA Notice: 104 Industry Standards of Medical Devices Published  11/29/2013 
 Notify of Products List of ClassⅡMedical devices Exempt from Submission of Clinical Trial Documents (second batch)  10/24/2013 
 The Responsibilities, Internal Structure and Staffing of CFDA Authorized by the State Council04/17/2013 
 Borderline Case of 17 Products12/24/2012 
 Secondly Proposed Technical Guidance: IVD Reagents for Detection of HIV, HBV-DNA and Specified IgM Antibodies to Pathogen09/28/2012 
 The Notice on the Corresponding Issues of Nano-silver Products Re-registration09/25/2012