A Description of the Preferential Approval Procedure for Medical Devices

Issued on October 26, 2016

A"medical device priority approval procedures"will be implemented on January 1, 2017,issued by the State Food and Drug Administration.

17 procedures include the purpose and basis, the scope of priority approval, application, review, publicity procedures, priority requirements, and the implementation date and so on.

(A) The scope of priority approval

First priority approval for medical equipment is the diagnosis or treatment of rare diseases, malignant tumors, which has significant clinical advantages; Medical devices are effective for diagnosis or treatments to specific and multiple diseases of elder person, which are invaluable in China; Others withobvious clinical advantages dedicated to children, or the medical equipmentare not registerin China, buturgency on clinical. Second, the devicesare included in the national science and technology major projects or national key research and development program.

Priority approval may be necessary fordevicesin other cases. The procedures set the "other necessary priority approval of medicaldevices." After expert reviewed, the food and drug administration willjudge the priority approval, in accordance with various aspects and opinions.

(B) Procedures of priority approval

The application for priority examination and approval to registration should be included in the products of the national science and technology major projects or the national key research and development programs.After reviewing andpublicity without any doubt,the administration will produce itpriority. The applicant shall submit the relevant supporting documents.

The products for the diagnosis or treatment of special diseases orurgent clinical needs, as well as "other priority approval of medical devices," will be implementation of priority by the StateAdministration every month, after organizing experts to demonstrate and publicity without doubt.

In accordance with the receiving time of a separate order,the administrationwill judge the priority of technical reviewing;afterthe verificationof provincial departments, the device will be approvedadministrativelyby the General Administration.

(C) Identificationof special casesincluding the rare disease, specific and multiple diseases of elderly, clinical necessary urgentlyetc.

Special casesrefers to the health condition of our community, which will various with thedevelopmentof social and technological, disease diagnosis and treatment, thechangesofcitizens health,including the rare disease, specific and multiple diseases of elderly, clinical necessary urgentlyetc.The implementation process of this procedure,the administration will organizethe clinical experts to review, then to determine the priority approval.

(4) The relationship among “the emergency examination and approval procedures for medical devices”,“the special examination and approval procedures for innovative medical devices” and this procedure

“Emergency approval procedure”will meetpublic health emergenciesneeds, within the prescribed time limit to complete the medical device registration approval work. “Innovative medical equipment special approval process” is for the core technology invention patents, leading international, domestic initiative, with significant clinical application value of medical devices, in accordance with the early intervention.The person responsible, strengthen communication, priority to support the principle. This procedure is different from the purpose and content of the emergency approval process and the innovation approval procedure.

This procedure runs in parallel with the innovative medical device special examination and approval procedures. The applicant can choose to apply for the appropriate proceduresaccording to the specific circumstances of the product.The producthas been in accordance with the "medical device emergency approval procedures", "innovative medical equipment special approval procedures (Trial)" for approval of the registration application, will not the suitable of this procedure.

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