AsianScientist (Nov. 3, 2015) – The Laboratory Testing Division (LTD) of WuXi PharmaTech (Cayman) Inc. has launched preclinical medical device testing services in China. These services are being offered for Chinese and international clients for their product registration with the China Food and Drug Administration (CFDA) and for Chinese clients for product registration in global markets.
LTD’s preclinical medical device testing services in China include a complete portfolio of biocompatibility, microbiology, and chemistry testing services. Major tests being offered include in vitro cytotoxicity, acute, sub-chronic and chronic toxicity, irritation, sensitization, hemocompatibility, implantation, genotoxicity, carcinogenicity, effects on reproduction, including development effects, extractable and leachable testing, and chemical characterization. WuXi has been a leader in providing preclinical and clinical medical device testing services in the United States for many years.
WuXi’s operations in Shanghai and Suzhou have successfully passed inspections by the Food and Drug Administration (FDA), CFDA, and Organisation for Economic Co-operation and Development (OECD) and audits by many clients for Good Laboratory Practice (GLP) studies. The company has the world-class laboratory and AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care)-inspected animal facility headed by a highly experienced international management team and staffed by well-trained technicians.
“China’s medical device industry is growing rapidly, and WuXi is committed to providing domestic and international medical device companies with the same high quality of testing services in China that we have provided for years in the United States,” said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech. “This new service offered brings WuXi one step closer to achieving our vision of offering a complete platform of R&D services for global life-science companies.”
Source: WuXi PharmaTech; Photo: Shutterstock.
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