CFDA Releases Medical Device Review Communication Management Plan
Medical Device Review Communication Management Measures (Trial)
Chapter I General
The first is to implement the reform requirements of the medical device review and approval system, encourage medical device innovation, guarantee the clinical use of medical devices, and strengthen the Medical Device Technology Evaluation Center (hereinafter referred to as the Appraisal Center) and applicants of the State Food and Drug Administration. The communication between them is based on the "Innovative Medical Device Special Approval Procedure (Trial)" (Food and Drug Administration [2014] No. 13) and "Medical Device Priority Approval Procedure" (State Food and Drug Administration announced 2016 No. 168) No.), formulate these measures.
Article 2 The communication and communication referred to in these Measures refers to the stage of the application for the registration of innovative medical devices, the stage of technical review and the stage of technical review for the approval of medical device registration applications. Communication and communication conducted by the registration application.
Article 3 The innovative medical devices and priority approval medical devices in these Measures refer to innovative medical devices that have been approved in accordance with the "Special Approval Process for Innovative Medical Devices (Trial)" (Food and Drug Administration [2014] No. 13). The third category and imported second and third types of medical devices approved by the “Approval Procedure for Medical Device Approval†(No. 168 of the State Food and Drug Administration announced in 2016).
Chapter II Forms of Communication
Article 4 When an applicant needs to verify or consult a general technical issue, it may go through the technical review consultation platform, telephone, fax, mail, letter, etc. of the inspection center and the review department of the inspection center (hereinafter referred to as the evaluation department). ) Communicate.
Article 5 The communication applicable to the meeting includes the following situations:
(1) Meetings held by innovative medical devices prior to the acceptance of registration applications mainly include the following issues:
1. Major technical issues;
2. Major safety issues;
3. Clinical trial protocol;
4. Summary and evaluation of the results of phased clinical trials;
5. Other issues that require communication.
(2) Innovative medical devices and priority approval of medical devices held at the technical review stage, at the request of the applicant, focus on the topical communication and communication on the contents of the supplementary information notice.
Chapter III Presentation of Communication Meeting
Article 6 The convening of a communication meeting shall meet the following basic conditions:
(1) Submitting the "Application Form for Medical Device Evaluation Communication Meeting" (Attachment 1);
(2) The submitted information should provide a reasonable solution or explanation basis for the issues to be discussed;
(3) The professional background of the participants in the communication meeting should meet the needs of discussion on professional issues;
(4) Issues with clear opinions and suggestions are no longer repeated.
Article 7 The applicant shall submit the “Application Form for Communication and Evaluation of Medical Device Evaluation†and relevant materials in writing to the corresponding review department.
Article 8 The evaluation department shall review the “Application Form for Communication and Evaluation of Medical Device Evaluation†submitted by the applicant and the information, and designate the person or the leader of the review team to fill out the “Application for Approval of the Medical Device Review Communication Meeting†(attached) 2) Review by the Minister or the responsible person and be approved by the Deputy Director. The evaluation department shall notify the applicant of the results of the audit within 3 working days after the approval of the communication application (Attachment 3).
Article 9 Where a communication meeting is determined, each reviewing department and the applicant shall agree on the date, place, agenda, and participants of the meeting.
Article 10 The general meeting of communication and communication meetings shall be held within 20 working days after the approval of the communication and communication application.
Chapter IV Preparation for Communication Meeting
Article 11 The applicant shall submit the paper or electronic materials of the communication meeting as required by the review department. The paper materials shall be signed by the designated person of the evaluation department or the leader of the evaluation team; the electronic materials shall be submitted to the evaluation department's work mailbox.
Article 12 In order to ensure the quality and efficiency of the communication meeting, the pre-conference review department shall designate a person or a team leader to conduct full consultation with the applicant. Participants in the examination center should review the meeting materials before the communication meeting and form preliminary opinions.
Article 13 The communication and communication meeting for the participation of experts shall be carried out in accordance with the "Specifications for the Consultation Meeting of Medical Device Technical Evaluation Experts/Explanation of Experts' Public Demonstration".
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