Medical network - on October 27, to ensure the clinical use of medical equipment, according to the regulations on the supervision and administration of medical devices (state council order no. 650), the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) and other relevant provisions, the state food and drug supervision and management of administration to make the medical equipment preferred examination and approval procedures, are hereby issued, and effective as of January 1, 2017.

Notice is hereby given that the.

Attachment: medical equipment preferred examination and approval procedures

The food and drug supervision bureau

On October 25, 2016

The attachment

Medical equipment preferred examination and approval procedures

Article 1 in order to guarantee the need medical devices for clinical use, according to the regulations on the supervision and administration of medical devices (state council order no. 650), the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) and other relevant provisions, formulate the program.

Article 2 the state food and drug supervision and administration bureau to meet the following conditions within the territory of one of the third class and import for the second and third class medical device registration approval implementation of priority:

(a) comply with any of the following circumstances medical devices:

1. The diagnosis or treatment of rare diseases, and has significant clinical advantage;

2. The diagnosis or treatment of malignant tumor, and has significant clinical advantage;

3. The diagnosis or treatment of aged and multiple disease, and there is no effective diagnosis or treatment.

4. Dedicated to children, and has significant clinical advantage;

5. Urgent clinical needs, and in our country, there is no medical instrument with varieties of products are allowed to register.

(2) listed in the national science and technology major projects or research and development of the national key program of medical apparatus and instruments.

(3) other shall give priority to the examination and approval of medical devices.

Article 3 for the purposes of this program the second subparagraph (a), (2), need according to the prior approval of the program, the applicant shall be submitted to the state food and drug supervision and administration bureau to apply for prior approval.

For this procedure (3) the second article, by the state food and drug administration bureau widely listen to opinions, and organize experts after the argument.

Article 4 the second article to conform to this procedure (a), (2), the applicant shall submit for medical device registration submitted when medical equipment application form (see attached 1) for examination and approval of priority.

For this program (2) of article 2 of the situation of medical apparatus and instruments is preferred for examination and approval of application, the applicant shall also submit the products listed in the national science and technology major projects or national key r&d plan of related documents.

Article 5 the state administration of food and drug supervision and administration of medical device registration acceptance department to review form of priority for examination and approval of the application materials, the priority for examination and approval of the application materials are complete and shall accept the application for registration of the project, indicate the priority request for approval, transfer of total bureau of national food and drug supervision and administration of medical devices technical evaluation center (hereinafter referred to as the trial center) for review.

Article 6 for this program (1) the second article situation of medical apparatus and instruments is preferred for examination and approval and shall give priority to other application of medical apparatus and instruments, implement certification center centralized organization expert argumentation monthly audits, issue the audit opinion. By experts required prior approval, the argument for prior approval.

For this program (2) of article 2 of the situation of medical apparatus and instruments is preferred for examination and approval of application, implement audit center within five working days from the date of receiving the application for review, in conformity with the preferred examination and approval conditions, to give priority for examination and approval.

Article 7 the trial center will formulate priority for examination and approval of projects of the applicant, name of product, to accept the number shall be published on its web site, the public time shall be not less than five working days. The public notice period without objection, the priority in the process of review, and inform the applicant.

Article 8 to object to the public project, it shall be submitted to implement trial center in fair show period in writing and explain the reasons (see attached objection to table 2). Device whose center shall be within 10 working days after receipt of the objection, study of relevant opinions, and shall inform the applicant and the objection to study the opinions.

Article 9 the trial center approved by audit will not be priority, will not be preferred examination and approval opinions and reasons to inform the applicant, and according to the regular examination and approval procedure.

Article 10 the device whose center for medical device registration of listed in the priority for examination and approval, sorted by receiving time alone, priority for technical review.

Article 11 for the first approval of the project, the provincial food and drug supervision and administration department quality priority to arrange medical device registration management system verification.

Article 12 for the first approval of the project, whose center in the process of technical evaluation, shall, in accordance with the relevant provisions, actively communicate with the applicant, when necessary, can arrange special communication.

Article 13 for the priority for approval to domestic medical device registration project, implement audit center confirmed the product belongs to the second category of medical devices that are accepted by the department in a timely manner will declare the second category of medical device registration data classification opinions to the applicant is located and the provincial food and drug supervision and administration department for examination and approval of the review.

Article 14 for the preferred examination and approval of projects, whose center indicated in the technical evaluation report for priority project examination and approval, the state food and drug administration of management priority to administrative examination and approval.

Article 15 is according to the examination and approval procedures for emergency medical devices, innovative medical equipment special examination and approval procedures for examination and approval of registration project, does not perform this procedure.

Article 16 provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department may reference program to carry out the second category of medical device registration in the administrative areas preferred examination and approval work.

Article 17 the program shall be implemented as of January 1, 2017.