On January 13, 2014, the China Food and Drug Administration (CFDA) issued a Guide for Regular Site Inspections of Medical Device Manufacturers. The Guide is to be used by local authorities and inspectors during a site inspection of device manufacturing facilities. It includes detailed guidelines as to all facets of the inspection, including the credentials of the inspectors, the necessary company background information collected in preparation, the step by step process for conducting the inspection, and the content of the systems and materials to be examined.
A “regular” medical device manufacturer inspection refers to various different types of routine inspections that are conducted by food and drug regulatory authorities at different levels of local government pursuant to the regulations and standards governing medical devices. These inspections are conducted on companies that have obtained a license to engage in medical device manufacturing or, in the case of a manufacturer of Class I devices, undergone required notification procedures with local authorities. CFDA further defines the term “regular inspection” as a site inspection of device manufacturing facilities and processes, including inspections of “quality systems,” inspections of “special issues,” and product quality spot-checks.
The Guide has several notable features with relevance to industry. First, it sets standards for the inspectors. Inspectors must have familiarity with Chinese medical device law and regulation, technical knowledge and understanding of the products they are inspecting, knowledge of relevant product standards, and “strong communication and comprehension abilities.” Second, the Guide encourages communication between the inspectors and company employees throughout the inspection. The Guide states that inspectors should “zealously” communicate with the company’s management and endeavor to understand the company’s history and circumstances.
Finally, after the close of the inspection, the inspectors should consider the issues uncovered, the process of the inspection, any corrective measures made by company, and the company’s track record to date. On the basis of these considerations, the Guide sets forth nine potential enforcement measures: (1) re-inspection by the authorities, (2) required product testing in outside government-accredited laboratories, (3) increased, targeted monitoring of the company, including surprise inspections and product sampling, (4) required periodic quality management reports, (5) additional discussions with company representatives, (6) reports of particular circumstances via bulletin or a warning in the mass media, (7) inclusion on a safety black-list for medical devices; (8) a recommendation of a voluntary or mandatory recall; and (9) reports of issues to the enforcement authorities for further handling.
The Guide does not change the existing regulations on medical device manufacturing or good manufacturing practices. However, it is a useful resource that will likely help to unify expectations of officials and industry regarding inspections. Domestic and foreign medical device companies with manufacturing facilities in China should pay close attention to the Guide in preparing for future site-inspections.