In order to ensure the clinical use demand of medical devices, according to the regulations on the supervision and administration of medical devices (Order No. 650 of the State Council) and the opinions of the State Council on reforming the review and approval system of drugs and medical devices (GF [2015] No. 44), the State Food and drug administration has organized and formulated the priority approval procedure for medical devices, which is hereby promulgated, Effective as of January 1, 2017.
It is hereby announced.
Annex: priority approval procedure for medical devices
Food and Drug Administration
October 25, 2016
Annex: priority approval procedure for medical devices
Article 1 in order to ensure the clinical use needs of medical devices, these procedures are formulated in accordance with the regulations on the supervision and administration of medical devices (Order No. 650 of the State Council), the opinions of the State Council on the reform of the evaluation and approval system of drugs and medical devices (GF [2015] No. 44) and other relevant provisions.
Article 2 the State Food and drug administration shall give priority to the examination and approval of the application for registration of domestic class III and imported class II and class III medical devices that meet one of the following conditions:
（1） Medical devices that meet one of the following conditions:
1. Diagnosis or treatment of rare diseases with obvious clinical advantages;
2. Diagnosis or treatment of malignant tumors with obvious clinical advantages;
3. Diagnose or treat the specific and multiple diseases of the elderly, and there is no effective diagnosis or treatment at present;
4. It is specially used for children and has obvious clinical advantages;
5. There is a clinical urgent need for medical devices, and there is no approved registration of the same kind of products in China.
（2） Medical devices listed in major national science and technology projects or national key R & D plans.
（3） Other medical devices that should have priority in examination and approval.
Article 3 in the case of items (1) and (2) of Article 2 of these procedures, the applicant shall apply to the State Food and Drug Administration for priority examination and approval in accordance with these procedures.
For the situation in Item (3) of Article 2 of these procedures, the State Food and drug administration shall listen to opinions widely and organize experts to demonstrate and determine.
Article 4 for those who meet the conditions in items (1) and (2) of Article 2 of these procedures, the applicant shall submit the application form for priority approval of medical devices together with the application for registration of medical devices (see Annex 1).
For the application for priority approval of medical devices under the circumstances of item (2) of Article 2 of these procedures, the applicant shall also submit the relevant supporting documents for the inclusion of the product in the national major scientific and technological projects or national key R & D plans.
Article 5 the medical device registration application acceptance Department of the State Food and drug administration shall conduct formal examination on the application materials for priority approval, indicate the priority approval application for the registration application items with complete application materials for priority approval and accepted, and submit them to the medical device technical evaluation center of the State Food and drug Administration (hereinafter referred to as the device examination center) for examination.
Article 6 for the application for priority approval of medical devices under item (1) of Article 2 of these procedures and other medical devices that should be given priority approval, the device Audit Center shall organize experts to demonstrate and review every month and issue audit opinions. If the examination and approval need to be given priority after demonstration by experts, it is proposed to give priority to examination and approval.
For the application for priority approval of medical devices under item (2) of Article 2 of these procedures, the device Review Center shall review it within 5 working days from the date of receiving the application. If it meets the priority approval conditions, it is proposed to give priority approval.
Article 7 the center shall publicize the applicant, product name and acceptance number of the proposed priority approval items on its website, and the publicity time shall not be less than 5 working days. If there is no objection during the publicity period, it shall be given priority to enter the review procedure and inform the applicant.
Article 8 if there is any objection to the publicized project, it shall submit a written opinion and explain the reasons to the audit center within the publicity period (see attachment 2 for the objection form). The Audit Center shall study the relevant opinions within 10 working days after receiving the objection, and inform the applicant and the party raising the objection of the research opinions.
Article 9 if the center of machine audit does not give priority to examination and approval after examination, it shall inform the applicant of the opinions and reasons for the refusal, and handle it according to the conventional examination and approval procedures.
Article 10 the medical device registration applications listed in the priority examination and approval shall be sorted separately according to the receiving time, and the technical review shall be given priority.
Article 11 the provincial food and drug administration shall give priority to the verification of the quality management system for the registration of medical devices for the projects that have priority in examination and approval.
Article 12 for the projects that have priority in examination and approval, the equipment examination center shall actively communicate with the applicant in accordance with relevant regulations in the process of technical evaluation, and can arrange special exchanges when necessary.
Article 13 for the domestic medical device registration application project that applies for priority examination and approval, if the device examination center confirms that the product belongs to class II medical devices, the receiving department shall timely transfer the registration application materials and classification opinions of class II medical devices to the provincial food and drug supervision and administration department where the applicant is located for review and approval.
Article 14 for the items that have priority in examination and approval, the equipment examination center shall indicate in the technical evaluation report that they are priority items for examination and approval, and the State Food and drug administration shall give priority to administrative examination and approval.
Article 15 the registration application items that have been approved in accordance with the emergency approval procedures for medical devices and the special approval procedures for innovative medical devices shall not implement this procedure.
Article 16 the food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the central government may, with reference to these procedures, give priority to the registration and approval of class II medical devices within their administrative regions.
Article 17 these procedures shall come into force as of January 1, 2017.
Source: State Food and Drug Administration
