China’s FDA Releases Quality Checklist for Medical Device Production Facilities

In April 2016, the China Food and Drug Administration (CFDA) released a set of guidelines that regulatory officials should follow when inspecting medical device production facilities. The checklist provides inspectors with a comprehensive list of specific elements they should investigate including personnel, organization, cleanliness, production management, and equipment maintenance. 25 different medical devices are covered in the checklist guidelines, including disposable catheters, bone implants, syringes, and blood collection devices. The release of the quality checklist is part of a larger medical device quality campaign that has seen the CFDA revise GMP and GCP rules in an effort to improve standards throughout the country.