On August 28, 2009, the State Food and Drug Administration (the SFDA) issued the Circular on Approval Procedures for Medical Devices in Emergencies. The Circular was issued in order to ensure the timely registration of medical devices needed in public health emergencies. The Circular, consisting of 14 articles, came into force on the day of its promulgation.

In the event that a threat to the public health arises or a public health emergency occurs, the SFDA will adopt an emergency approval procedure to register necessary medical devices. According to the circumstances of the public health emergencies, the SFDA may when to begin and end such emergency approval procedures.

The emergency approval procedure applies to the registration of medical devices that are needed in public health emergencies and meet the following conditions: (1) there are no similar products already approved for distribution in the Chinese market; or (2) there are similar products that are approved for distribution in the Chinese market, but the product supply can not meet the demand in the emergency situation at hand.

Applicants seeking to apply to register their medical devices through emergency approval procedures should first submit the summary documents and relevant introduction documents for medical devices to the SFDA for review. The SFDA will, within three days, make a decision on whether or not to adopt the emergency approval procedure to register the medical devices, and will inform the applicant of its decision.

According to the Circular, for those Class II or Class III medical devices that the SFDA has agreed to adopt emergency approval procedures to register, the relevant branches of the SFDA should, within five days after receiving the application for issuance of a Medical Device Manufacturing Permit Certificate or the application of modification of a Medical Device Manufacturing Permit Certificate filed by the manufacturer, make a decision on whether or not to issue or modify said Certificate.

The SFDA expedites the registration of medical devices during public health emergencies. Under the Circular, for Class I medical devices, the relevant food and drug authorities need to complete both a technical review and an administrative review within five (5) days after the acceptance of the application for medical device registration. For Class II medical devices, the relevant food and drug authorities need to complete the technical review within five (5) days after the acceptance of the application for medical device registration, and need to complete an administrative review within three (3) days after the completion of the technical review. For Class III medical devices, the relevant food and drug authorities should complete the technical review within ten (10) days after the acceptance of the application for medical device registration, and should complete an administrative review within three (3) days after the completion of the technical review.