Medical network - on February 8, to implement the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), the innovation medical instrument special approval procedures (trial)" (food drug safety machinery tube [2014] no. 13) and the medical equipment examination and approval procedures for priority (the state food and drug administration administration announcement no. 168, 2016), the state food and drug supervision and management of administration to make the "medical device review communication management approach (trial)" (attachment), are hereby issued.
Please take note.
Attachment: review of medical equipment communication management approach (trial)
The food and drug supervision bureau
On February 3, 2017
The attachment
Medical device review communication management approach (trial)
The first chapter is always
Article 1 with a view to the implementation of the medical device review for examination and approval system reform, to encourage the innovation of medical equipment, to ensure the clinical use of medical equipment, to strengthen the administration of state food and drug supervision and administration of medical devices technical evaluation center (hereinafter referred to as the trial center) communication between the applicant and, based on the innovative medical devices for examination and approval of special program (try out) "(drug safety food machinery tube [2014] no. 13) and the medical equipment examination and approval procedures for priority (the state food and drug administration administration announcement no. 168, 2016), these measures are formulated.
Communication referred to in article 2 hereof, refers to the innovation for medical device registration before acceptance, technical review stage and prior approval for medical device registration technology review stage, the applicant, by a device whose center with the applicant for registration items of communication.
Article 3 these measures of innovative medical devices and medical apparatus and instruments of examination and approval refers to the priority has agreed to by the innovative medical devices for examination and approval of special program (try out) "(drug safety food machinery tube [2014] no. 13) for examination and approval of the innovation of the medical equipment and according to the medical equipment examination and approval procedures for priority (the state food and drug supervision and administration bureau announcement no. 168 2016) for examination and approval of the third class and import the second, three types of medical equipment.
The second chapter in the form of communication
Article 4 the applicant needs to verify general technical problems or consulting, technical evaluation can implement trial center for consultation platform, telephone, fax, E-mail, letter with the form of trial center review department (hereinafter referred to as the review department) to communicate.
Article 5 is suitable for the meeting communication consists of the following circumstances:
(a) innovation medical instrument in accepting the application for registration of meeting, mainly including discuss the following questions:
1. The major technical problems;
2. Major safety issues;
3. Clinical trial scheme;
4. The phase of clinical trial results summary and evaluation;
5. Other issues need to communicate.
(2) the innovation of medical equipment and medical apparatus and instruments for examination and approval of priority meeting in technical evaluation stage, at the request of an applicant, focusing on additional information content in the notice of project communication.
The third chapter put forward communication meeting
Article 6 the communication meeting shall meet the following basic conditions:
(a) to submit the medical device review communication meeting application form "(1);
(2) submit the response to discuss problems put forward reasonable solution or interpretation;
(3) the professional background of communication meeting personnel shall meet the needs of the discussion for professional problem;
(4) has clear opinions and Suggestions of problems are no longer repeated communication.
Article 7. The applicant shall submit in writing the medical instrument the review communication application form and relevant materials to the corresponding department review.
Article 8 review department to deal with the applicant to submit the medical device review communication application form and information for review, and appoint someone or review team leader to fill in the medical device review communication meeting application form (attached 2), by the minister or head of the review, in charge of the deputy director for approval. The review department should apply for examination and approval in communication within 3 working days after will notify the applicant (3) the results of audit.
Article 9 to determine the communication meeting, the review and agreed on the date of the meeting, place the applicant information, agenda and attendees.
Article 10 the communication meeting general arrangement in the communication for approval within 20 working days.
The fourth chapter communication meeting
Article 11 the applicant should be submitted in accordance with the requirements of the review department communication meeting of paper or electronic data. Paper appoint someone or review by the review team leader to sign for; Electronic data submitted to the review department mailbox.
Article 12 the quality and efficiency in order to ensure the communication meeting, before the meeting review department assign or review team leader should be full consultation with the applicant. Device before trial center should participants in communication meeting to review meeting information, and forms a preliminary opinion.
Article 13 for the need to invite experts to participate in the communication meeting, should refer to the medical instrument technical evaluation expert consultation/public discussion meeting operation specification of execution.
Article 14 the existence of the following circumstances, the meeting be cancelled:
(a) submit the meeting is not in conformity with the requirements;
(2) of the applicant is put forward to cancel the meeting and agreed by implement trial center.
After meeting canceled, the applicant may apply for communication separately according to the requirements of these measures.
The fifth chapter communication meeting
Article 15 the general communication meeting presided over by the review department minister or head, according to the pre-determined agenda of the meeting. The review department will arrange or review team leader should participate in the meeting all the way, and record the meeting.
Article 16 after the meeting, the applicant shall pay the relevant taxes in accordance with the communication meeting minutes template (4) attached requirements in a timely manner to write meeting minutes, all the review department minister or head of audit confirmation, assign or review by the review team leader within 10 working days after the end of the meeting will be meeting minutes sent to the applicant. Meeting minutes as the important document on file, and as an important reference of the review.
The sixth chapter is attached
Article 17 the applicant when submit an application for medical instrument communication, shall appoint one contact person. Contacts should be familiar with medical device registration regulations. The applicant should communicate through contacts with the umpire center, implement audit center also only designated contact person in contact with the applicant. If the contact is changed, the applicant shall inform the trial center.
Article 18 device whose center communication meeting, the present measures shall be proposed by the personnel designated by the review of department or the review team leader and applicant consultation, determine the communication meeting time, place and agenda and information requirements.
Article 19 the communication work must be strictly implemented in the present measures, shall not violate the rules of examination center.
Article 20 these measures come into force from the date of release. |
