Medical network - April 17 

 

Provinces, autonomous regions and municipalities directly under the food and drug administration, the relevant units: 

 

In order to strengthen and standardize the administration of state food and drug supervision and administration of medical device classification management committee, the state food and drug supervision and administration bureau made the administration of the state food and drug supervision and administration of medical device classification technology committee work rules, are hereby printed and distributed, please comply with them. 

 

The food and drug supervision administration office 

 

On April 13, 2017 

 

Administration of state food and drug supervision and administration of medical device classification technology committee work rules 

 

The first chapter the general 

 

Article 1 with a view to further strengthen the classified management of medical equipment, play the role of professionals working in the medical device classification, according to the regulations on the supervision and administration of medical devices "medical device classification rules" the relevant provisions of the state food and drug administration management is a medical device classification technology committee (hereinafter referred to as the classification of technical committee). 

 

The second classification technology committee formed by the state food and drug administration bureau and management, under the leadership to carry out medical device classification and related work. 

 

Article 3 for the purpose of regulating the classification of the technical committee work, improve the medical device classification management mechanism, to ensure the scientific nature of the medical device classification, impartiality and authority, these rules are formulated. 

 

The second chapter of the organization and responsibilities 

 

Article 4 the classification technical committee by the executive committee (hereinafter referred to as "commission") and a number of professional. 

 

The director committee member 1 set by the executive committee, the standing committee, deputy director of 1, deputy director of the committee of several; All the professional group leader 1, deputy head of 1. Executive director committee member, deputy director of standing committee, deputy director of the committee members, members and professional group leader, deputy leader, committee members, both for the classification of the technical committee. 

 

Article 6 of the executive committee, director of the committee member by well-known experts, related technology, deputy director of the standing committee, deputy director of the committee by experts in the field of related technologies and administration of state food and drug supervision and management of the relevant management personnel, commissioners of experts in the field of medical equipment technology and management. 

 

Article 7 the professional group leader, deputy group leader, committee on the assessment by the clinical medicine, engineering, and of experts in the field of inspection, supervision and management, etc. The professional composition generally for 15-20 members. 

 

Committee member may concurrently hold the professional committee members, part-time in principle no more than a professional. Executive and professional should give full consideration to the proportion of people from different fields, in principle the same unit in the same field of members is not more than two. 

 

Article 8 the executive committee meeting held at least once a year. According to the requirements of the job, not regular meeting. Board responsibilities: 

 

(a) the medical devices category framework important items, such as the content, the classification rules to adjust technical advice; 

 

(2) the review commission annual work plan; 

 

(3) officer of classification technology committee for professional qualifications; 

 

(4) classification review committee changes work procedures and committee work related matters; 

 

(5) coordinated professional research on major matters of the job; 

 

(6) to carry out other duties assigned by the administration of state food and drug supervision and administration work. 

 

Article 9 for professional according to the work arrangements, not regular meeting, to carry out the relevant classification of medical equipment professional field, daily and special work. Professional responsibilities: 

 

(a) take the professional medical equipment product category catalogs of determination and adjustment of technical research, and puts forward technical advice and Suggestions; 

 

(2) to undertake the professional medical device classification theory research and technology demonstration; 

 

(3) research and track the development trend of domestic and foreign medical device classification; 

 

(4) to carry out other duties assigned by the classification technology committee executive committee; 

 

(5) bear the administration of state food and drug supervision and administration of medical devices standards management center (hereinafter referred to as the tube center) entrust other relevant work. 

 

Article 10 the classification standard tube technical committee secretariat is located in the centre, by the tube center director as general secretary, arrangement of the secretariat of full-time staff to carry out the work. The secretariat of the main responsibilities: 

 

Classification of (a) is responsible for day-to-day management of the technical committee and member of the contact work; 

 

(2) is responsible for the relevant work system and work mechanism of drawing up and implementation supervision; 

 

(3) the organization to carry out product category catalogs of determination and adjustment and so on technical review and related research work; 

 

(4) to the professional technical advice and consistency of regulations and audit; 

 

(5) to undertake professional product category catalogs of determining and adjusting operation and archive work; 

 

(6) medical equipment product category information construction related work; 

 

(7) the professional conduct of transition and member of the supplement, replace work; 

 

(8) to carry out other duties assigned by the classification technology committee executive committee work. 

 

Article 11 if any special or major special matters specified in the product category, according to the needs of work, the secretariat may propose to set up temporary professional. Temporary professional members from relevant professional or from the expert database according to the committee to be included in the conditions of the selection, and approved by the state food and drug supervision and management of the administration in accordance with the procedures. 

 

Temporary professional consult professional duties and procedures to carry out the corresponding work, the group leader and deputy team leader shall be for the classification of the technical committee. 

 

The third chapter member management 

 

Article 12 of the secretariat of the organization's member selection, supplement and adjust the replacement, submitted to the state food and drug administration bureau according to the relevant procedures for approval. 

 

The condition of article 13 of the member 

 

(a) compliance, style decent, the work is earnest, have good professional ethics and integrity awareness; 

 

(2) be familiar with the relevant laws and regulations of medical equipment, has a wealth of medical apparatus and instruments related working experience, have deep knowledge of medical device classification work, work in the field more than 8 years; 

 

(3) technology in the field of committee shall have senior professional and technical titles or equivalent level, to master the professional academic frontiers and technical developments, enjoying high reputation in the industry and prestige; 

 

(4) management committee should understand medical equipment at home and abroad in the field of laws and regulations, familiar with the classified management present situation and development trends of medical equipment, is engaged in the management of medical device classification and related affairs; 

 

(5) members age in principle shall be under the age of 65 on-the-job personnel can be (of age). 

 

Article 14 members produce process 

 

(a) the board director committee member, deputy director of the standing committee, deputy director of the committee member and member by the state food and drug administration bureau on the basis of widely soliciting the opinions of experts hired. 

 

(2) professional committee produced according to the following procedure: 

 

1. Recommended by relevant units, fill out the committee recommended table (attachment); 

 

2. The secretariat of the presenter qualification review and data information, in accordance with the principle of professional composition, proposed for professional committee member list of candidates as well as the group leader, deputy head of the recommended candidate; 

 

3. The committee candidates main information in the administration of state food and drug supervision and administration of publication and the tube center website 7 working days and no objection; 

 

4. Each professional committee member by the state food and drug administration bureau employment approved by the relevant procedures. 

 

(3) the classification of the technical committee for appointment of five years. 

 

Article 15 the committee responsibilities and obligations 

 

(a) abide by all provisions of this regulation; 

 

(2) executive board resolutions and the professional; 

 

(3) commission, where professional distribution of each work mission on time and of conferences and events; 

 

(4) to participate in the executive committee and the professional related question discussion, proposed opinions; 

 

(5) to collect information related to medical equipment technology development, dynamic tracking technology development at home and abroad and regulatory policy development, supervision of medical devices make recommendations; 

 

(6) strictly abide by the confidentiality provisions and consent, related matters are not permitted to be released without authorization, transcribing and gaiden; 

 

(7) signing of a declaration of no conflict of interest, and I have an interest and activities of the interest relations, shall be offered to avoid; 

 

(eight) honesty, probity, and may not use classification technology committee of identity to obtain illegitimate interests. 

 

Article 16 member of any of the following circumstances, the recommendations to the secretariat, the state food and drug administration of management audit, shall be: 

 

(a) fails to fulfill the member responsibility, more than three consecutive did not attend the meeting or more than three times not reply back to the umpire striking; 

 

(2) in violation of the regulations of secrecy; 

 

(3) using the member identity to obtain illegitimate interests, adverse consequences; 

 

(4) because of body reason no longer suited to the related work; 

 

(5) I resign from the post of commissioner in writing. 

 

The fourth chapter work procedures 

 

Article 17 of the executive board and professional practice, director of the committee member, group leader responsibility system, director, deputy director of the standing committee, deputy director of the committee members to assist member, deputy head of the work to assist the team leader, director of the committee and professional group leader can't attend the meeting or work, by the deputy director of the standing committee, deputy director of the committee member and deputy head of the substitutive. 

 

Article 18 the whole committee conference convened by the executive committee, director of the committee is responsible for. 

 

Article 19 the board meeting shall be convened by the director of the committee is responsible for, or are entrusted by the standing committee, deputy director of committee, director of the call, more than two thirds of the executive committee shall attend. According to the need can invite professional leader, relevant experts, industry organization and enterprise representatives to attend the meeting. 

 

Article 20 professional conferences or activities related to the team leader is responsible for the call, according to the condition of work organization, shall, in accordance with the provisions of the program review classification information. If needed, the review can be adopted came or functional trial. Using came way, according to different work items, determine of all professional committee meeting or part of the committee meeting, involving major items, the product category adjustment should be made all the committee members meeting in principle, more than two-thirds of all the committee meeting shall members attended the meeting. According to the need can invite relevant experts, industry organization and enterprise representatives attend the meeting and can attend on behalf of their opinions, but not to participate in the vote. 

 

Article 21 the board, professional conference in forming opinions and Suggestions, should be after a full discussion, consensus in principle. Need to vote, shall be present at the meeting agreed to by two-thirds or more of the members of the committee. 

 

Article 22 the classification by the technical committee secretariat chapter generation tube center. 

 

The fifth chapter working funds 

 

Article 23 the classification committee work funds according to the state food and drug administration regulations into the related budget management, members involved in classification of transportation, accommodation and labor remuneration paid by the tube center according to the relevant provisions of the state. 

 

Article 24 the funds use the unit should be strictly in accordance with the relevant regulations of the state finance department, the rational use of funds, and accept the supervision and inspection. 

 

The sixth chapter bylaws 

 

Article 25 the rules by the state food and drug administration bureau is responsible for the interpretation. 

 

Article 26 the rules will take effect from the date of release.