Medical network on March 29 - to implement the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), to further improve the quality and efficiency of medical equipment technical evaluation, the state food and drug supervision and management of administration to make the measures for the administration of medical devices technical evaluation expert advisory committee, are hereby issued, and shall come into force as of the date of release. 

 

Notice is hereby given that the. 

 

Attachment: measures for the management of medical equipment technical review expert advisory committee 

 

The food and drug supervision bureau 

 

On March 21, 2017 

 

Medical equipment technical evaluation for management expert advisory committee 

 

The first chapter is always 

 

Article 1 with a view to give full play to the medical device registration review technical advisory expert technical support, perfect the technology decision-making mechanism, better performance of the technical evaluation function, clear responsibility, rights, obligations and consulting experts management requirements, according to the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa (2015) 44) regulation, draw lessons from international experience, combined with the medical device registration review practice, these measures are formulated. 

 

Article 2 the state food and drug supervision and administration bureau (hereinafter referred to as the bureau) to establish medical instrument technical evaluation expert consulting system, set up the medical instrument technical evaluation expert advisory committee (PRB) (hereinafter referred to as the expert advisory committee). 

 

Article 3 the state food and drug supervision and administration of the administration of medical devices technical evaluation center (hereinafter referred to as the trial center) to establish expert advisory committee, member of the selection and supplementary work, responsible for the daily operation, the expert advisory committee meeting organization and service related work. 

 

Article 4 the expert advisory committee work should follow the scientific, in accordance with the law, the principle of open, fair and objective. 

 

Expert advisory committee on duty should abide by the basic requirement of scientific, rigorous, fairness and justice. 

 

The second chapter of expert advisory committee 

 

Article 5. According to the requirements of the scientific development, technological progress and review, set up different expert advisory committee in the field of disciplines and specialties. 

 

Article 6 each expert advisory committee should be composed of experts involved in the professional field, the number according to the actual situation. 

 

Article 7 set each expert advisory committee, director of the committee member and deputy director of the committee members each one. 

 

The third chapter expert consultation committee qualifications 

 

Article 8 the expert consultation committee shall have the following qualifications: 

 

(a) adhere to the principle, has the good professional ethics, serious and responsible, probity, right; 

 

(2) related disciplines involved in medical apparatus and instruments, such as medicine, acoustics, electronics, materials, mechanical and electrical, optical, pharmacology, toxicology, biological evaluation, biometric has deep attainments, familiar with the professional situation and development trend at home and abroad, with senior professional and technical titles or an equivalent professional level; 

 

(3) be familiar with the medical device laws, regulations and policy requirements; 

 

(4) can guarantee undertake and complete the required medical device registration review of technical consultation and so on related work, to attend the meeting on time. 

 

(5) health, employment age is generally not more than 65 years old. Academician of age can relax appropriately. 

 

Article 9 of the director of the committee, deputy director of the committee members in addition to meet the above conditions, also should have the following conditions: 

 

(a) the professional involved field has deep attainments, academic level can get widely recognized this professional scholars, is a senior professional title or an equivalent professional level; 

 

(2) be familiar with the professional medical equipment innovation and development trend both at home and abroad; 

 

(3) be familiar with the professional medical equipment at home and abroad present situation of clinical application and regulation; 

 

(4), director of the committee members shall be the member of, or the professional leader. 

 

The fourth chapter expert consultation committee responsibilities and tasks 

 

Article 10 the expert consultation committee's main responsibility is to participate in the trial center organization of argumentation, consultation, decision-making work, the review provide theoretical guidance for medical device registration, policy advice, business consulting and technical support. 

 

Article 11 is the main task of the expert advisory committee: 

 

(a) to participate in medical instrument technical evaluation argumentation of major, difficult problems; 

 

(2) to participate in medical instrument technical evaluation expert consultation, correspondence consulting work; 

 

(3) to participate in the innovation of medical equipment examination work; 

 

(4) involved in medical equipment priority review of examination and approval; 

 

(5) to participate in the innovation of medical equipment communication work; 

 

(6) to participate in medical instrument technical review review work; 

 

(7) to participate in medical instrument technical evaluation guidelines and revising consulting work; 

 

(8) to carry out other duties assigned by the editor whose center related work. 

 

Article 12 the expert consultation committee should be the center of the receiver on the inspection and supervision. 

 

Article 13 because of health and other reasons can not participate in the medical device registration review technical consulting expert advisory committee, should be a written report to implement trial center, elucidate the reasons for cannot attend technical advisory work and time limit. 

 

Article 14 the device whose center each year for an expert personal information updates and credentials. When the work unit, the department, contact information, such as personal information changes, expert consultation committee shall inform the trial center. 

 

The fifth chapter expert consultation committee of rights and obligations 

 

Article 15 the expert consultation committee after the administration of accept appointment, enjoy the following rights: 

 

(a) fully published personal opinions and Suggestions; 

 

(2) receptors on the related business in the center of the training; 

 

(3) in accordance with the relevant financial regulations to obtain corresponding labor remuneration; 

 

(4) according to the I intend to resign; 

 

(5) other rights prescribed by the laws, regulations and rules. 

 

Article 16 the expert consultation committee shall perform the following obligations: 

 

(1) strictly comply with national laws, regulations and rules such as the regulations for the relevant work; 

 

(2) adhering to the scientific and fair, serious and responsible attitude for medical devices to be consulted to comment on the safety, efficacy and quality controllable, and put forward the opinion; 

 

(3) in the consultation shall not be leaked before the conclusion of consultation, strictly guarding state secrets, by consulting medical instrument technical secrets and declare unit business secret, without permission shall not be extracted, references, and gaiden consulting data, not publicly in technical consultation before the meeting I have to attend the meeting information and other relevant information; 

 

(4) to participate in the consultation, demonstrating the work such as the opinions and Suggestions should be conducive to the development of related industries; 

 

(5) the signing of a declaration of no conflict of interest, and I have an interest and interest relationship of technical advisory work, offered to avoid; 

 

(6) cooperate with audit center consulting work schedule and attend the meeting on time, and within the time limit as prescribed complete advice; 

 

(7) in administration of medical devices technical evaluation expert advisory committee name to participate in commercial activities; 

 

(8) other obligations stipulated by laws, regulations and rules, etc. 

 

The sixth chapter expert consultation committee selected employment program 

 

Article 17 the expert consultation committee can take personal recommendation, recommend and implement trial center invited a combination of selection. 

 

(a) in the trial center website published the required professional category requirements and employment conditions; 

 

(2) trial center collects the medical instrument technical review center consulting experts application form (see chart), and review of relevant material, determine the expert consultation committee list; 

 

(3) the list of candidates in the trial center website announces 7, after the will of the public administration of candidate list report without objection, upon examination and approval by the administration after the appointment, printed and issued by the food and drug supervision administration job offers. 

 

Article 18 device whose center can also according to the following procedure for directly to the unit or organization. 

 

(a) sent a letter to the relevant units or organization, told recommended conditions and related material requirements, consult expert committee candidates; 

 

(2) the candidate information submitted for each unit or organization and related materials for review, determine the expert consultation committee candidates; 

 

(3) the list of candidates in the trial center website announces 7, after the will of the public administration of candidate list report without objection, upon examination and approval by the administration after the appointment, printed and issued by the food and drug supervision administration job offers. 

 

Article 19 the expert advisory committee members need to submit the following information: 

 

(a) the association of archives work unit, or seal of the administration of state food and drug supervision and administration of medical devices technical review center consultant application form of the original; 

 

(2) the highest qualification, degree and professional qualification certificate copy. 

 

Article 20 for expert advisory committee on insufficient resources, technical advice in urgent need of special professional direction, the trial center review department recommendation, center leadership after approval, can choose the temporary experts to participate in the technical advisory work related. Implement audit center regular program will according to the interim experts into the expert advisory committee. 

 

Article 21 the director committee member, deputy director of the committee recommended by device whose center review department, whose center and approved. 

 

Article 22 the expert consultation committee a five-year term, after the expiration of the tested and approved by the commissioner I application and device center qualified, can be renewed. 

 

Article 23 the expert consultation committee of the following circumstances, implement audit center after approval, reported to the administration shall, after the dismissal shall not be employed again. 

 

(a) because of objective reasons I can't normal rite; 

 

(2) fulfills the responsibility can not be objective and fair; 

 

(3) engaging in activities of harm the image of the government; 

 

(4) to provide false personal material; 

 

(5) the daily inspection is unqualified, above 3 times failed to attend the meeting on time, or more than 3 times failed to complete technical advisory work within a prescribed period of time; 

 

(6) in administration of medical devices technical evaluation expert advisory committee name to participate in commercial activities; 

 

(7) in violation of the laws, regulations and relevant provisions of the state; 

 

(eight) affect their normal role and other circumstances. 

 

Chapter 7 expert advisory committee works 

 

Article 24 the expert advisory committee works mainly include letters consulting experts, expert consultation and public discussion meeting, written advice issued by expert advisory committee. 

 

Article 25 letters consulting mode refers to a device whose center review member, written by E-mail consult experts committee, in order to solve the technical problems in the daily review. 

 

Article 26 the expert consultation refers to a device whose center review member of unknown mechanism for the innovative medical apparatus and instruments, first appeared in medical apparatus and instruments, medical equipment, or for similar products in the domestic market, but because of material, structure, principle, scope of application, indications and other major change, the existing review basis, experience cannot be effectively grasp the medical apparatus and instruments, in product registration review process, the need to consult technical problems in the form of meeting to consult experts committee put forward. 

 

Article 27 the experts in public discussion meeting is to solve the major technical issues and major, complex science and technology and organization's meeting. 

 

Chapter 8 letters consulting work procedures 

 

Article 28 for need letters consulting products, whose center related review member shall present need to consult to the review of the problems and reasons, discuss after through the review department, review member can, written by E-mail to the expert consultation committee members need to consult technical problems are put forward. 

 

Article 29 of the expert advisory committee to review part put forward the technical question to give timely advice. To solve the problem of should clarify scientific basis; Can't solve the problem of, should be the reasons why. 

 

Article 30 the review part deal with the opinions of the expert advisory committee in time to save, combining with the practical work to make the review conclusion. 

 

Chapter 9 experts consultation process 

 

Article 31 for product suggest a expert consultation, whose center related review member shall be made to the technical committee review department points, clear held a reason according to the expert consultation, and technical problems of the consultation. Points and technical committee to deal with the previous product review and expert consultation as a whole analysis, after discussed, still cannot solve the technical problems of the consultation, agreed to hold the expert consultation, submit an application for the expert consultation, determine the expert consultation committee as the number of professional, scale, and in principle for singular number, by the review, the review head in charge of the leadership for approval. 

 

Article 32 device whose center integrated service department should be in after receipt of the application for the expert consultation, submit the expert consultation meeting notice to the applicant, the applicant received the meeting information, determine the meeting time, and the expert consultation before the meeting, the meeting time, place, and related information to mail expert committee. 

 

Article 33 the personnel to participate in the expert consultation limited to expert advisory committee and audit center related review member. For the applicant to attend, whatsoever that researchers can be present at the meeting about product development, clinical trials, display/demo sample, and the expert consultation committee member and related evaluation questions to answer on the spot, but not to take part in internal discussions. 

 

Article 34 after the expert consultation, the review should be timely to expert advisory committee in the consensus on consulting issues, there are different opinions, such as adoption comb, summarizing the contents of Shared within the department, in a timely manner to provide the reference for subsequent similar products technical evaluation work. 

 

Chapter 10 experts public discussion meeting procedures 

 

Article 35 experts public discussion meeting should be organized according to the following procedure: 

 

(a) by the umpire center review department to apply for the meeting, after approval, the centre. 

 

(2) the meeting information 

 

Device whose center integrated service department should be at least 25 working days before the meeting to confirm the meeting time and attendees, apply to the meeting for departments and related enterprise information to notice (if any). Meeting for departments and relevant enterprises (if any) received material preparation should be within 5 working days after notification submit conference center integrated service department. 

 

(3) the notice of the meeting 

 

Device whose center integrated service department meeting notice will be 15 working days before the meeting and the related data of electronic version or paper information sent to the relevant participant representatives of members and attend, so that the corresponding preparation. 

 

Besides involving state, trade secrets, technical secrets, the meeting shall be held publicly. 

 

Set up the public gallery, and at least 15 working days before the meeting to the society through the network platform to inform public discussion meeting time, place and content, according to the arrangement of enrollment situation bystander. 

 

(4) other matters relating to the preparation meeting 

 

Implement trial center integrated service department shall be responsible for meeting the application department, attending committee members and other attendees are meeting problems of communication and liaison, and meeting arrangements, venue layout, equipment preparation, meeting information issued by the related preparation work. 

 

(5) resolution of the meeting 

 

After the public discussion meeting, conference resolution shall open the device whose center's official website. 

 

Article 36 experts public discussion meeting agenda is as follows: 

 

(a), director of the committee or committee, deputy director of the meeting host, introduce the present and background, declared the meeting agenda and discipline; 

 

(2) the application department report meeting, time control within 40 minutes; 

 

(3) if applicable, the relevant companies on behalf of the statement, for meeting the application department puts forward problems were stated and explained, time control within 40 minutes; 

 

(4) members, attend representatives and other observers question publicly demonstrate content, communication, meeting for departments and relevant enterprises on behalf of the answer should be objective (if any), detailed, in order to facilitate decision making; 

 

(5) related enterprise representative (if any) and other attendees withdrawal, commissioner for the discussion of the issues with representatives attend, form the final opinion for the controversial problems, according to the principle of the minority is subordinate to the majority vote to make a decision, to attend on behalf of non-voting; 

 

(6) the host announced the end of the meeting. 

 

Article 37 device whose center, in principle, should according to expert review department public final opinion formation technology review opinions; There are major differences, should be in the technical evaluation report in this paper, the reasons and basis. 

 

Chapter 11 expert consultation committee work discipline 

 

Article 38 expert advisory committee may not accept declaration units, and to declare the present of the relevant intermediary agencies and related personnel, shall not privately with the above-mentioned units or personnel for technical consultant may affect the impartiality of contact. 

 

Article 39 if expert advisory committee system by consulting research participants, director of the medical device or to unit the leadership, should take the initiative to implement trial center that is avoided in the technical consultation. With medical devices to be consulted to declare unit and individual shall have any other concerns, and may affect the science, impartiality and fairness review other condition, also should be avoided in the technical consultation. 

 

Article 40 as expert advisory committee during the following situations occurs, is testified, implement trial center, according to serious degree can be questioning to expert advisory committee, the administration for approval after the dismissal, and notify the commissioner in unit. 

 

(a) under the condition of known information not offered to avoid; 

 

(2) in consulting leaked before the conclusion of advice; 

 

(3) without the consent of the reporting unit leaked without authorization by consulting medical instrument technical secrets and declare units of commercial secrets or excerpts, references, and gaiden consulting information gain; 

 

(4) accepted declare units, and declare the gift which the relevant intermediary agencies and related personnel, cash, securities or other interests; 

 

(5) with medical devices to be consulted between the reporting unit and individual participation, holding, or other related interests. 

 

(6) other circumstances to violate the work discipline. 

 

Chapter 12 consulting payments 

 

Article 41 the expert consultation committee to participate in the medical device registration review technical consultation work of transportation, accommodation and labor remuneration paid by device whose center according to the relevant provisions of the state. 

 

Article 42 in medical device registration review technical advisory work achievements and outstanding contribution expert advisory committee, whose center as the case to give praise or rewards. 

 

Chapter 13 is attached 

 

Article 43 the measures by the state food and drug administration bureau is responsible for the interpretation. 

 

Article 44 the measures from the date of release.