China Announces Registration Fees; Class III Imports to Cost $50K

May 29, 2015

The China Food and Drug Administration Wednesday announced registration fees for locally made and imported medical devices aimed at speeding up the processing of applications.

Sponsors of imported Class III devices must pay approximately US $49,802 for initial registration, while locally made Class III devices are charged $24,772. For Class II devices, registration fees are set at the provincial level for locally made products, and at $34,008 for imports.

In addition, devicemakers must pay a continuing registration fee of $6,579 every five years for imported Class II devices and all Class III devices. Continuing fees for locally made Class II devices are set at the provincial level.

There is also a $6,966 fee for clinical trials of Class III devices.

Devicemakers can still register Class I devices for free, and fees may be waived on a case-by-case basis for small and micro businesses with innovative technologies, the CFDA says. To apply for the waiver, companies must submit a copy of their business license, recent tax returns and a notice from the CFDA stating the device is innovative.

AdvaMed’s China staff is discussing the new fees with the CFDA under the auspices of the Joint Commission on Commerce and Trade, says Ralph Ives, executive vice president of global strategy and analysis.

View the fees notice, in Chinese, at www.fdanews.com/06-01-15-registration.pdf.
— Elizabeth Orr