China Food and Drug Administration to Conduct Surprise Inspections

August 28, 2015

Devicemakers in China can expect surprise inspections from that country’s Food and Drug Administration starting Sept. 1, according to guidance.

The CFDA says companies can expect teams of investigators who will document the inspection process, identify problems and relevant evidence, examine findings and make recommendations for improvement.

The guidance follows a May 18 notice that provided information on the inspections. “Since the inspection regulation is supposed to take place effective Sept. 1, this guidance is coming about six weeks ahead, which should give the industry sufficient preparation,” says Helen Chen, director and partner at L.E.K. Consulting. She adds that the government has been looking to address medical product quality issues.

Inspections may be launched based on complaints or credible reports of quality and safety risks, an adverse event report, serious recordkeeping problems or violations of quality management standards.

The government has several options for dealing with companies with serious problems.

“The violators can have their production and sales licenses temporarily revoked, and thus be unable to continue their business,” Chen says. “They can also be reported to the Public Security Bureau and publicly shamed via press conferences. There are no fees or financial compensations specifically mentioned.”

Once any risks have been eliminated, actions taken against the company will be lifted, the guidance says.

Stay up to date on Chinese regulations with our Webinar CD/Transcript Understanding China’s New Medical Device Regulations, and you will be fully prepared when the country’s Food and Drug Administration shows up for a surprise inspection!