All provinces, autonomous regions, municipalities directly under the Central Government, Xinjiang Production and Construction Corps Drug Administration, and 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 working rules of the Medical Device Classification Technical Committee of the Food and Drug Administration to form the "Working Rules of the Medical Device Classification Technical Committee of the National Drug Administration", which is hereby printed and distributed for implementation.

General Department of the State Drug Administration

March 10, 2023

State Drug Administration

Working Rules of the Technical Committee on Classification of Medical Devices

Chapter I General Provisions

Article 1 In order to strengthen the classification management of medical devices, improve the classification mechanism of medical devices, standardize the work of the classification technical committee, and ensure the scientific, normative, impartial, and authoritative classification of medical devices, these Rules are formulated 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.

Article 2 The State Drug Administration (hereinafter referred to as the SDA) shall establish a Technical Committee for Classification of Medical Devices (hereinafter referred to as the Technical Committee for Classification).

Under the leadership of the State Drug Administration, the Classification Technical Committee carries out classification and related work on medical devices (including in vitro diagnostic reagents), providing technical support for the classification management of medical devices.

Chapter II Organization and Responsibilities

Article 3 The Classification Technical Committee is composed of an Executive Committee (hereinafter referred to as the Executive Committee) and several professional groups. In principle, the classification technical committee is changed every five years.

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

Institutional members are those who represent relevant functional departments and units as members and hold positions above. Institutional members are subject to a seat system and are appointed by personnel recommended by relevant functional departments and units.

Individual members are mainly selected from experts in the fields of medicine, engineering technology, evaluation, and testing.

Article 5 The Executive Committee is composed of a chairman, two executive vice chairmen, deputy chairmen, and several members, with a total number generally not exceeding 50. Among them, the chairman is held by a well-known scholar in the relevant technical field, the executive vice chairman is held by the head of the Device Registration Department and the Device Standards Management Center, and the vice chairman is held by a well-known scholar in the relevant technical field and the head of the medical device related department of the National Drug Administration. The Executive Committee implements the responsibility system of the Chairman, 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. Meetings may be held irregularly according to work needs.

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

（1） Research and propose strategic decision-making recommendations for classified management of medical devices;

（2） Provide technical advice on the adjustment of medical device classification rules, the content of the classification directory framework, etc;

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

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

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

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

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

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

The professional group meets irregularly based on work arrangements and task requirements.

Article 8 The professional team mainly undertakes the following responsibilities:

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

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

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

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

（5） Carry out publicity and implementation training on the guiding principles for classification and definition of 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 is 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 Drug Administration for approval. After that, specifically organize the election, addition, and replacement of members 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 relevant research work such as product attribute definition, category determination, and classification catalog adjustment, and be responsible for reviewing the relevant technical opinions of the expert meetings and professional groups of the Classification Technical Committee;

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

（6） Propose a proposal to establish a temporary professional group based on work needs, and with the approval of the State 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 deliberation;

（8） Organize the annual evaluation of each professional group;

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

Chapter III Management of Committee Members

Article 10 Individual members shall meet the following requirements:

（1） Abide by discipline and law, have a decent style of work, work conscientiously, and have a good professional ethics and a sense of integrity;

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

（3） Have a senior professional and technical title or equivalent level, master the academic frontier and technological development trends in the field of their respective majors, and enjoy a high reputation and prestige in the industry;

（4） In principle, the age of members should be persons 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.

Candidates for institutional members shall be recommended by relevant functional departments and units with reference to the above conditions.

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

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

（1） Member of the Executive Committee

Based on extensive solicitation of opinions from national and provincial medical device regulatory authorities and experts, the secretariat proposed candidates for the Executive Committee members, and posted their main personal information on the website of the Device Standards Management Center for 7 days. The appointment was approved by the State Drug Administration.

（2） Professional team members

1. To be recommended by relevant units, fill in the committee member recommendation form (attachment);

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

3. The main information of the candidate for membership will be posted on the website of the Device Standards Management Center for 7 days;

The leader, deputy leader, and member of each professional group shall be appointed by the Secretariat after being approved by the State Drug Administration.

Article 13 The main responsibilities of members include:

（1） Comply with the provisions of these Rules;

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

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

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

（5） Strictly abide by confidentiality regulations, and do not release, transcribe, or disseminate relevant matters without permission;

（6） Honest and trustworthy, honest and impartial, and shall not use the membership of the Classification Technical Committee to obtain illegitimate benefits. For activities related to personal interests and interests, they shall actively propose to withdraw;

（7） Members shall promptly notify the Secretariat of any changes in their positions, resignations, retirements, and other 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 to which they belong;

（3） The right to criticize, recommend, 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） Adding members according to the classification of medical devices;

（2） A member voluntarily resigns;

（3） A member has been dismissed;

（4） Other situations where additional members are required.

The Executive Committee, the Professional Group, and the Secretariat may, based on work needs and relevant regulations, propose additional members for appointment in accordance with 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 his or her institution due to work, job changes, or other reasons, the institution shall promptly propose a change in the membership, report it to the secretariat for filing, and appoint him or her in accordance with relevant procedures.

Article 17 In case of any of the following circumstances, the secretariat shall make a proposal, submit it to the State Drug Administration for approval in accordance with the procedures, and then dismiss the member. The relevant information shall be published on the website of the Device Standards Control Center:

（1） Failing to attend classification related meetings for more than three consecutive times or failing to respond to classification letter review comments for more than three consecutive times;

（2） Violating confidentiality regulations;

（3） Obtaining illegitimate benefits by using the membership of a committee member, resulting in adverse consequences;

（4） No longer suitable for assuming the work of a committee member due to work, job changes, or other reasons;

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

Article 18 The Secretariat is responsible for evaluating the performance of members in accordance with the relevant provisions of Article 13 of these Rules, and the evaluation results serve as an important basis for adjustment and renewal of employment of members.

Chapter IV Working Procedures

Article 19 The meeting of the Executive Committee shall be convened by the chairman or the 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 issues, 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 in the form of on-site meetings or online meetings, and if necessary, they may also be consulted by letter to seek opinions from members.

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

Article 22 If opinions need to be formed at the plenary meetings of the Executive Committee and the professional group, they should be fully discussed and agreed upon through consultation. "If a decision needs to be made through a vote, it shall be adopted 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 sealed by the Device Standards Control Center.

Chapter V Working Expenses

Article 24 The working expenses of the Classification Technical Committee shall be included in the relevant budget management of the Device Standards Management Center in accordance with the provisions of the State Drug Administration.

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

Chapter VI Supplementary Provisions

Article 26 The State Drug Administration is responsible for the interpretation of these Rules.

Article 27 These Rules shall take effect as of the date of promulgation. The Notice of the General Office of the Food and Drug Administration on Printing and Distributing the Working Rules of the Medical Device Classification Technical Committee of the State Food and Drug Administration (SFDA BXG [2017] No. 56) shall be repealed simultaneously.