CFDA Provides Guidelines for Devicemakers Awaiting GMP Inspections

The China Food and Drug Administration has issued four guidelines that provide additional information for devicemakers awaiting good manufacturing practices inspections.

Covering GMP inspections in general, sterile devices, implantable devices and in vitro diagnostics, the guidelines are annexes to the main device GMP regulations issued in January, Ropes & Gray Partner Katherine Wang says. Mainly, they offer guidance to inspectors on how they should inspect manufacturing facilities, but they also can help companies prepare because they list what inspectors will look for when they conduct onsite GMP inspections.

“The appendixes set forth principles for the specific types of devices that represent higher risk,” Wang says.

Ames Gross, president of Pacific Bridge Medical, says the new guidelines should help with the overall quality of medical device manufacturing in China. “There is not much change for foreign companies manufacturing in China, since they already implement their own GMP,” he says. “However, the quality standards should improve for domestic Chinese companies that comply with the new guidelines, which would make Chinese-made devices more competitive globally.”

It has been a busy year for the CFDA in terms of ramping up device quality. In January, the regulator announced it would beef up its inspections system for medical devices by adding more investigators and improving the performance of quality testing centers. The changes also called for stronger leadership at the CFDA and local FDAs, better staff training, greater information sharing and a more coordinated approach.

The following month, China released revised GMPs for sterile and implantable devices.

Over the summer, China’s State Council unveiled new guidelines intended to make the medical device approval process more science-based and efficient. The guidelines, which affect pharmaceuticals, look to raise the review standards to those of international levels while helping enhance transparency throughout the device approval process. To that end, the council is aiming to improve registration, technical review, product testing and field inspection conditions.

Stay up to date on Chinese regulations with our management report 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!