The priority approval process for medical devices will take effect on January 1, 2017

In order to safeguard the clinical use of medical devices, in accordance with the Regulations on the Supervision and Administration of Medical Devices (Decree No. 650 of the State Council), the Opinions of the State Council on the Reform of the Review and Approval System for Pharmaceutical Medical Devices (Guofa (2015) No. 44) and other relevant provisions, the State Food and Drug Administration has organized and formulated the Priority Approval Procedure for Medical Devices, which is heeded and will come into effect on January 1, 2017.
this announcement.ArticlePriority Approval Procedure for Medical Devices
Article 1 In order to safeguard the clinical use of medical devices, this procedure is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices (Decree No. 650 of the State Council) and the Opinions of the State Council on the Reform of the System of Review and Approval of Pharmaceutical Medical Devices (Guofa (2015) No. 44).article
The State Administration of Food and Drug Administration shall give priority to the examination and approval of applications for registration of medical devices of category III and import of category II and class III medical devices in China that meet one of the following conditions:
(1) Medical devices that meet one of the following conditions:
1. Diagnosis or treatment of rare diseases, and have obvious clinical advantages;
2. Diagnosis or treatment of malignant tumors, and has obvious clinical advantages;
3. Diagnosis or treatment of endearing and multiple diseases in the elderly, and there is no effective diagnosis or treatment means;
4. dedicated to children, and has obvious clinical advantages;
5. Clinical urgent need, and there is no medical device approved for registration of the same variety of products in China.
(2) Medical devices included in major national science and technology projects or national key research and development programs.
(3) Other medical devices that should be approved as a matter of priority.
Article 3 Where the circumstances of Article 2 (1) and (2) of this Procedure require priority examination and approval in accordance with this Procedure, the applicant shall apply to the State Administration of Food and Drug Administration for priority examination and approval.
of Article 2 (3) of this Procedure shall be widely listened to by the State Administration of Food and Drug Administration and determined after organizing experts to demonstrate.
Article 4 Of any situation that complies with Article 2 (1) and (2) of this Procedure, the applicant shall submit the application form for priority approval of medical devices when submitting the application for registration of medical devices.
for the application for priority examination and approval of medical devices in the case of Article 2 (2) of this Procedure, the applicant shall also submit relevant supporting documents for the inclusion of the product in major national scientific and technological projects or national key research and development plans.
article 5 The medical device registration application receiving department of the State Food and Drug Administration shall conduct a formal examination of the application materials for priority examination and approval, and indicate the priority examination and approval application for registration applications with complete and accepted application materials, and transmit the application for priority examination and approval to the Medical Device Technical Review Center (hereinafter referred to as the Device Review Center) of the State Food and Drug Administration for examination and approval.
Article 6 For medical device priority examination and approval applications and other medical devices that should be given priority for examination and approval in the case of Article 2 (1) of this Procedure, the Equipment Audit Center shall centrally organize expert verification and examination on a monthly basis and issue audit opinions. If the expert demonstrates that priority approval is required, it shall be formulated for priority approval.
For medical device priority examination and approval applications in the case of Article 2 (2) of this procedure, the device examination center shall, within 5 working days from the date of receipt of the application, examine and approve the application as a matter of priority, and if it meets the priority examination and approval circumstances, it shall draw up priority examination and approval.
The 7th Device Review Center shall make public the applicant, product name and acceptance number of the priority approval item on its website, and the publicity time shall be not less than 5 working days. If there is no objection during the publicity period, it shall be given priority to enter the review process and inform the applicant.
objecting to the publicity project in Article 8, a written opinion shall be submitted to the Audit Center and the reasons shall be given during the publicity period (the objection form is attached to annex 2). The audit center shall, within 10 working days from the time of receipt of the objection, conduct a study on the relevant opinions and inform the applicant and the objector of the opinions.
the examination and approval of the 9th Device Review Center, the applicant shall be informed of the opinions and reasons for the non-priority examination and approval, and shall be handled in accordance with the normal examination and approval procedures.
, the 10th Device Review Center shall give priority to technical review of medical device registration applications included in the priority examination and approval, in a separate order according to the time of receipt.
, the provincial food and drug regulatory departments shall give priority to the verification of the quality management system for the registration of medical devices for priority approval projects.
Article 12 For priority items approved, the ercity examination center shall, in the course of technical review, actively communicate with the applicant in accordance with the relevant provisions and, if necessary, may arrange special exchanges.
Article 13 For an application for registration of domestic medical devices for priority examination and approval, if the device review center confirms that the product belongs to the second category of medical devices, the receiving department shall promptly transfer the registration and declaration information and classification opinions of the second category of medical devices to the provincial food and drug supervision and administration department where the applicant is located for examination and approval.
Article 14 For priority items, the ercity review center shall indicate them as priority approval items in the technical review report, and the State Administration of Food and Drug Administration shall give priority to administrative examination and approval.
15 registration application items that have been approved in accordance with the emergency approval procedure for medical devices and the special approval procedure for innovative medical devices shall not be implemented.
16 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may, in accordance with this procedure, carry out priority examination and approval of the registration of medical devices of the second category within the administrative area.
Article 17 Of this procedure shall come into effect on January 1, 2017. (State Administration of Food and Drug Administration)