Notice on Issuing the Work Rules of the Medical Device Classification Technical Committee of the State Drug Administration by the Comprehensive Department of the State Drug Administration

Yao Jian Zong Xi Zhu [2023] No. 23

All provinces, autonomous regions, municipalities directly under the central government, and the Xinjiang Production and Construction Corps Drug Administration, as well as relevant units:

In order to strengthen and standardize the work management of the Medical Device Classification Technical Committee of the National Drug Administration, the National Drug Administration has revised the original work rules of the Medical Device Classification Technical Committee of the Food and Drug Administration, forming the "Work Rules of the Medical Device Classification Technical Committee of the National Drug Administration". It is now issued and please follow and implement.

Attachment 1

National Drug Administration

Working Rules of the Medical Device Classification Technical Committee

Chapter 1 General Provisions

Article 1: In order to strengthen the management of medical device classification, improve the working mechanism of medical device classification, standardize the work of the classification technical committee, and ensure the scientific, normative, impartial, and authoritative nature of medical device classification, in accordance with the relevant requirements of the Regulations on the Supervision and Administration of Medical Devices, the Classification Rules for Medical Devices, and the Classification Rules for In Vitro Diagnostic Reagents, this rule is formulated.

Article 2: The State Drug Administration (hereinafter referred to as the State Drug Administration) shall establish a Medical Device Classification Technical Committee (hereinafter referred to as the Classification Technical Committee).

The Classification Technology Committee, under the leadership of the National Drug Administration, carries out the classification and related work of medical devices (including in vitro diagnostic reagents), providing technical support for the classification and management of medical devices.

Chapter 2 Organizational Structure and Job Responsibilities

Article 3: The Classification Technical Committee shall be composed of the Executive Committee (hereinafter referred to as the Executive Committee) and several professional groups. The classification technical committee is generally elected every five years.

Article 4: The members of the Classification Technical Committee include the Chairman of the Executive Committee, Executive Vice Chairman, Deputy Chairman, members, and professional team leaders, deputy team leaders, and members. The members of the Classification Technical Committee are divided into institutional members and individual members.

Institutional committee members are those who represent relevant functional departments and units to serve as committee members or above. Institutional committee members implement a seat system and are appointed by personnel recommended by relevant functional departments and units.

Individual committee members are mainly selected from experts in fields such as medicine, engineering technology, evaluation, and testing.

Article 5: The Executive Committee shall consist of one Chairman, two Executive Vice Chairmen, and several Vice Chairmen and members, with a total number generally not exceeding 50. Among them, the chairman is appointed by well-known scholars in the relevant technical field, the executive vice chairman is appointed by the head of the Device Registration Department and the Device Standard Management Center, and the vice chairman is appointed by well-known scholars in the relevant technical field and the head of the medical device related department of the National Drug Administration. The Executive Committee implements a chairman responsible system, and the Executive Vice Chairman and Vice Chairman assist the chairman in carrying out his work.

The Executive Committee meets at least once a year. According to work needs, meetings can be held irregularly.

Article 6: The Executive Committee shall mainly assume the following responsibilities:

（1） Research and propose strategic decision-making suggestions for medical device classification management;

（2） Provide technical suggestions for adjusting the classification rules of medical devices and the content of the classification directory framework;

（3） Summarize the annual work of the Classification Technical Committee;

（4） Review the annual work summary of the professional group;

（5） Guide the professional team to conduct research on major issues such as the management category of newly developed products and the adjustment of classification catalogs, and coordinate the resolution of major controversial issues between various professional teams;

（6） Provide technical guidance for the classification of medical devices in various provinces;

（7） Undertake other tasks assigned by the National Drug Administration.

Article 7: Each professional group shall be composed of a team leader, deputy team leaders, and members. The professional team implements a team leader responsibility system, and the deputy team leader assists the team leader in carrying out their work. Each professional group generally consists of 15-20 members.

The professional group holds irregular meetings based on work arrangements and task requirements.

Article 8: The professional team shall mainly undertake the following responsibilities:

（1） Undertake research and technical argumentation on the classification management of medical devices and related products in this professional field, and provide technical opinions and suggestions;

（2） Undertake technical research on the adjustment of medical device classification catalogs in this professional field, and provide technical opinions and suggestions;

（3） Research and track the current status and development trends of medical device classification management at home and abroad;

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4） Review the guiding principles for the classification and definition of products related to this professional field;

（5） Carry out publicity and implementation training on the guiding principles for classifying and defining the professional field;

（6） Provide technical guidance for the classification of medical devices in the professional field of each province;

（7） Undertake other tasks assigned by the Executive Committee and the Secretariat.

Article 9: The Secretariat of the Classification Technical Committee shall be located in the Medical Device Standards Management Center of the State Food and Drug Administration (hereinafter referred to as the Device Standards Management Center), with the relevant person in charge of the Device Standards Management Center serving as the Secretary General. The Secretariat mainly undertakes the following responsibilities:

（1） Draft a work plan for the election and selection of members of the Executive Committee and Professional Group of the Classification Technical Committee, and submit it to the State Food and Drug Administration for approval. After that, organize specific work such as the election, supplementation, and replacement of the Executive Committee and Professional Group of the Classification Technical Committee;

（2） Responsible for the daily affairs management and liaison work of the Classification Technical Committee;

（3） Responsible for drafting and supervising the implementation of relevant work systems and mechanisms;

（4） Organize the Classification Technical Committee to carry out research related to product attribute definition, category determination, and classification catalog adjustment, and be responsible for reviewing the technical opinions of the Classification Technical Committee's expert meetings and professional groups;

（5） Organize professional groups to review the guiding principles for the classification and definition of related products;

（6） Propose the establishment of a temporary professional group based on work needs, and with the approval of the State Administration for Drug Administration, carry out corresponding work in accordance with the responsibilities and procedures of the professional group;

（7） Summarize the annual work of the Classification Technical Committee and submit it to the Executive Committee for review;

（8） Organize annual evaluations of various professional groups;

（9） Undertake other tasks assigned by the National Drug Administration.

Chapter 3 Management of Committee Members

Article 10: Individual members shall meet the following conditions:

（1） Abide by laws and regulations, have a decent style of work, work diligently, possess good professional ethics and a sense of integrity;

（2） Familiar with relevant medical device laws and regulations, with rich experience in medical device related work, in-depth understanding of medical device classification work, and at least 8 years of work in related fields;

（3） Having a senior professional and technical title or equivalent level, mastering the academic forefront and technological development trends in the field of this major, and enjoying a high reputation and prestige in the industry;

（4） In principle, the age of committee members should be individuals under the age of 65 (the age of academicians can be appropriately relaxed);

（5） Actively participate in the relevant work of the Classification Technical Committee.

The selection of institutional committee members shall be recommended by relevant functional departments and units based on the above conditions.

Article 11: The composition of the Executive Committee and professional groups shall fully consider the proportion of personnel from different professions and management fields, and in principle, the number of members of the same unit in the same field professional group shall not exceed 2.

Article 12: The selection of members of the Technical Committee shall comply with the following procedures:

（1） Executive Committee Member

On the basis of extensive solicitation of opinions from national and provincial medical device regulatory departments and experts, the Secretariat proposes candidates for the Executive Committee members, and publishes their personal information on the website of the Device Standards Management Center for 7 days. They will be appointed with the approval of the National Drug Administration.

（2） Professional team members

1. Recommended by relevant units, fill out the committee member recommendation form (attachment);

2. The Secretariat shall review the qualifications and information of the recommended candidates, and propose a list of candidates for professional group members, as well as recommended candidates for the team leader, deputy team leader, and committee members, in accordance with the principles of professional group composition;

3. The main information of the candidate for the committee member will be publicly available on the website of the Device Standards Management Center for 7 days;

4. The leaders, deputy leaders, and members of each professional group shall be appointed by the Secretariat with the approval of the State Food and Drug Administration.

Article 13: The main responsibilities of a committee member include:

（1） Comply with the provisions of this rule;

（2） Implement various resolutions of the Executive Committee and the professional group;

（3） Undertake various work tasks assigned by the Executive Committee and their respective professional groups, participate in various meetings and activities on time, participate in discussions on relevant issues of the Executive Committee and their respective professional groups, and provide opinions;

（4） Collect relevant information on the development of medical device technology, track the development of domestic and foreign technology and regulatory policies, and provide suggestions and suggestions for medical device supervision work;

（5） Strictly abide by confidentiality regulations, and shall not publish, transcribe, or disseminate relevant matters without consent;

（6） Honest and trustworthy, honest and fair, and shall not use the identity of a member of the Classification Technical Committee to obtain improper benefits. For activities related to personal interests and interests, they shall actively propose to withdraw;

（7） Members shall promptly inform the Secretariat of any changes in their job positions, resignations, retirements, or other related circumstances related to their performance of duties.

Article 14: Members shall have the following rights:

（1） The right to know about the classification management system of medical devices;

（2） The right to review and vote on relevant technical opinions of the executive committee or professional group;

（3） The right to criticize, suggest, and supervise the work of the Classification Technical Committee;

（4） The right to express personal opinions and suggestions independently and fully;

（5） The right to participate in relevant activities, meetings, and professional training of the Classification Technical Committee;

（6） The right to receive corresponding labor remuneration according to regulations;

（7） Other rights stipulated by laws, regulations, and these rules.

Article 15: According to the actual classification work, individual members may be added under the following circumstances:

（1） According to the classification of medical devices, it is necessary to add members;

（2） A committee member voluntarily resigns;

（3） A committee member has been dismissed;

（4） Other situations where additional members are needed.

The Executive Committee, professional groups, and Secretariat may propose suggestions for adding members based on work needs and relevant regulations, and appoint them according to relevant procedures. The number of additional members generally does not exceed 10% of the total number of members at the time of establishment.

Article 16: During the term of office, if a member of an institution is no longer suitable to represent the institution due to work, job changes, or other reasons, the institution shall promptly propose a change in the member, report it to the Secretariat for filing, and appoint it in accordance with relevant procedures.

Article 17: If a committee member falls under any of the following circumstances, the Secretariat shall make a suggestion, submit it to the State Food and Drug Administration for approval in accordance with the procedures, and dismiss it. The relevant information shall be published on the website of the Device Standards Control Center:

（1） Not attending classification related meetings for more than three consecutive times or not responding to classification letter review opinions for more than three consecutive times;

（2） Violating confidentiality regulations;

（3） Using the identity of a committee member to obtain illegitimate benefits, resulting in adverse consequences;

（4） Due to work, job changes, or other reasons, it is no longer suitable to undertake the work of a committee member;

（5） I submit in writing my resignation as a committee member.

Article 18: The Secretariat shall be responsible for evaluating the performance of committee members in accordance with the relevant provisions of Article 13 of these rules, and the evaluation results shall serve as an important basis for the adjustment and renewal of committee members.

Chapter 4 Work Procedures

Article 19: The Executive Committee meeting shall be convened by the Chairman or Executive Vice Chairman. The professional group meeting shall be convened by the professional group leader or deputy group leader. For the plenary meetings of the Executive Committee and professional groups held for major matters, the number of members present should not be less than two-thirds of the total number of members.

Article 20: The Executive Committee and professional group meetings may be held on-site or online, and if necessary, they may also be solicited for opinions from committee members through correspondence.

Article 21: According to work needs, professional group meetings may invite other relevant professional group members, relevant experts, industry organizations, or enterprise representatives to attend the meeting as nonvoting delegates, who shall participate in the discussion but not vote.

Article 22: If opinions need to be formed during the plenary meetings of the Executive Committee and professional groups, they shall be fully discussed and agreed upon through consultation. If a decision needs to be made through voting, it shall be passed with the consent of two-thirds or more of the members present at the meeting.

Article 23: The Secretariat of the Classification Technical Committee shall be stamped by the Equipment Standards Control Center.

Chapter 5 Work Funds

Article 24: The working expenses of the Classification Technical Committee shall be included in the relevant budget management of the Device Standard Management Center in accordance with the regulations of the State Food and Drug Administration.

Article 25: The device standard management center shall strictly use funds in accordance with the relevant regulations of the national financial department and accept supervision and inspection.

Chapter 6 Supplementary Provisions

Article 26: The interpretation of these rules shall be the responsibility of the State Food and Drug Administration.

Article 27: These rules shall come into effect from the date of promulgation. The Notice of the General Office of the Food and Drug Administration on Issuing the Work Rules of the Medical Device Classification Technical Committee of the State Food and Drug Administration (Food and Drug Administration Office Document No. 56 [2017]) shall be abolished simultaneously.