3 Sep 2009 11:40

SFDA to fast track approval of medical devices used during public health emergencies

Shanghai. September 3. INTERFAX-CHINA - China's State Food and Drug Administration (SFDA) issued a new policy on Sept. 2 that is intended to speed up the examination and production approval process of medical devices used during public health emergencies in China.

According to the new policy named the Procedure for Examining and Approving Medical Devices for Emergency Use, which took effect on Aug. 28 this year, the fast track approval procedure is applicable to medical devices used during public health emergencies that have not been marketed in China or if existing production cannot meet the demands during such events.

The policy encourages medical device makers to keep drug administrations abreast of product development, even before filing an application for production approval. It stipulates that government-designated departments will examine medical device samples within 24 hours, and drug administrations will check production facilities within two days of an application being made.

The policy also states that class three medical devices, which need to adhere to the highest safety standards, will have their technology appraised by the SFDA within 10 days. The SFDA has three days after that to approve or reject production.

Provincial-level drug administrations will appraise the technology of class two medical devices within five days and approve or reject production within three days.

City-level drug administrations must appraise the technology of class one medical devices and approve or reject production within five days.

"This is the first such policy from the SFDA that lists specifics to speed up the approval process for medical device production, although in the past, there have been fast track approval cases," an employee surnamed Wang, from DaAn Gene Co. Ltd. of Sun Yat-sen University in Guangzhou City, told Interfax on Sept. 3.

"This is good news for companies like DaAn Gene, which develops various kinds of test kits to detect viruses, because normally, the examination and approval of a test kit will take one month at the very least, and can last up to several months," she said.