Chinese Regulators Release New Medical Device Clinical Trial Regulations

Last year, the China Food and Drug Administration (CFDA) issued a number of regulations for drug clinical trials. This year, the CFDA is continuing its long-term regulatory overhaul by improving medical device regulations.

In May 2016, the CFDA released three documents that will assist inspectors as they conduct inspections of medical device clinical trials. Inspectors will now use a standardized checklist that they should follow when inspecting the medical device clinical trial process. In addition, the CFDA has created a seven-step process that regulatory teams will follow when conducting site visits. This process will help harmonize the inspection process in a country where various provinces and localities may have their own particular formats and procedures.

The CFDA has also released a list of medical devices that will be exempt from the clinical trial process. Exemptions will only be extended to products that have met the same principals established by products that have already undergone trials. New products that have different designs, functions, or materials will have to undergo new clinical trials. The CFDA aims for these regulations to improve China’s overall clinical trial procedure and harmonize the country’s inspection process.