Contract research organization WuXi PharmaTech ($WX) announced that it's launching preclinical medical device testing services for product registration in China, which is obtained via the China Food and Drug Administration (CFDA).
The services will be offered by the WuXi's laboratory testing division, the company said in a release. They include tests for in vitro cytotoxicity; acute, subchronic and chronic toxicity; irritation; sensitization; hemocompatibility; implantation; genotoxicity; carcinogenicity; effects on reproduction; extractability and and leachability; and chemical characterization, the release says. And the company's operations in Shanghai and Suzhou have passed audits monitoring good laboratory practice by the FDA, the CFDA, and various clients.
Also, the tests can be used for product registration in global markets, at least in the case of Chinese clients, Shanghai-based WuXi says.
In addition to various facilities in China, the company operates three FDA-registered facilities in the U.S., including one for medical device chemistry testing in Atlanta. It also operates a life science reagents distribution facility in San Diego and a genomics facility in Reykjavik, Iceland, according to the company website.
"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 WuXi CEO Dr. Ge Li, in a statement. "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."
WuXi's focus on its home country's medical device industry comes as the CFDA makes a number of moves to beef up its regulation of the sector. The agency just issued guidance documents on good manufacturing practices and onsite inspections of sterile and implantable devices, as well as in vitro diagnostic reagents. And in July, the CFDA warned that it will begin conducting unannounced inspections.
While WuXi focuses on the preclinical side of the equation, industry bigwigs are most worried about China's clinical trial paradigm, including CFDA calls for clinical trials on many devices generally exempt from them in other countries and China-specific trials that would be duplicative. Favorable treatment of domestic companies and devices manufactured in China is another concern.
- read the release
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