Updated on 26 October 2015
LTD's preclinical medical device testing services in China include a complete portfolio of biocompatibility
Singapore: China's WuXi PharmaTech's Laboratory Testing Division (LTD) has launched preclinical medical device testing services in China. The service include Chinese and international clients for their product registration with 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 passed inspections by the FDA, CFDA, and OECD and audits by many clients for GLP studies.
"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, WuXi PharmaTech. "This new service offering brings WuXi one step closer to achieving our vision of offering a complete platform of R&D services for global life-science companies."