The "Administrative Measures for Medical Device Standards" was reviewed and approved by the State Food and Drug Administration's executive meeting on February 21, 2017. It is hereby promulgated and will come into force on July 1, 2017.
Director: Bi Jingquan
April 17, 2017
Medical Device Standards Management Measures
Chapter 1 General
Article 1 In order to promote the progress of science and technology, ensure the safety and effectiveness of medical devices, improve the level of health protection, and strengthen the management of medical device standards, in accordance with the "Standardization Law of the People's Republic of China", "Regulations on the Implementation of the Standardization Law of the People's Republic of China" and "Regulations on the Supervision and Administration of Medical Devices 》And other laws and regulations, formulate these measures.
Article 2 The “medical device standards” mentioned in these Measures refer to the uniformity followed by the State Food and Drug Administration in accordance with its responsibilities, organization and revision, and promulgation according to legal procedures, in the development, production, operation, use, supervision and management of medical devices. Technical requirements.
Article 3 The establishment, revision, implementation, supervision and management of medical device standards within the territory of the People's Republic of China shall abide by laws, administrative regulations and the provisions of these Measures.
Article 4 Medical device standards are divided into mandatory standards and recommended standards according to their effectiveness.
The technical requirements for ensuring human health and life safety should be formulated as mandatory national standards and mandatory industry standards for medical devices.
The technical requirements for meeting basic general requirements, supporting mandatory standards, and playing a leading role in the medical device industry can be formulated as recommended national standards and recommended industry standards for medical devices.
Article 5 Medical device standards are divided into basic standards, method standards, management standards and product standards in accordance with their standard objects.
Article 6 The State Food and Drug Administration shall formulate plans for medical device standards in accordance with the law, establish a medical device standard management system, and improve the medical device standard management system.
Article 7 Encourage enterprises, social organizations, educational and scientific research institutions and individuals to participate extensively in the formulation and revision of medical device standards, and supervise the implementation of medical device standards.
Article 8 Encourage participation in international standardization activities, participation in the formulation and adoption of international medical device standards.
Article 9 The State Food and Drug Administration shall commend and reward organizations and individuals that have made outstanding achievements in the work of medical device standards in accordance with relevant national regulations.
Chapter II Standards Management Responsibilities
Article 10 The State Food and Drug Administration shall perform the following duties:
(1) Organizing and implementing relevant laws and regulations on medical device standard management, and formulating a medical device standard management work system;
(2) Organizing the formulation of a medical device standard plan, and formulating an annual work plan for standard formulation and revision;
(3) Organize the formulation and revision of medical device standards in accordance with the law, and publish medical device industry standards;
(4) Guide and supervise the management of medical device standards in accordance with the law.
Article 11 The Medical Device Standards Management Center of the State Food and Drug Administration (hereinafter referred to as the "Medical Device Standards Management Center") shall perform the following duties:
(1) Organize and carry out research on the medical device standard system, and formulate a draft medical device standard plan and annual work plan recommendations for standard formulation and revision;
(2) Undertaking the management of the formulation and revision of medical device standards in accordance with the law;
(3) Undertaking the management work of the Medical Device Standardization Technical Committee in accordance with the law;
(4) Undertaking the organization of the publicity and training of medical device standards;
(5) Organizing investigations into the implementation of standards, and coordinating and solving major technical problems in the implementation of standards;
(6) Undertake the relevant work of international standardization activities of medical devices and foreign cooperation and exchange;
(7) To undertake the informatization of medical device standards and organize the publication of medical device industry standards;
(8) To undertake other standard management tasks assigned by the State Food and Drug Administration.
Article 12 According to the needs of medical device standardization work, the State Food and Drug Administration shall, upon approval, establish a medical device standardization technical committee in accordance with the law.
The Medical Device Standardization Technical Committee performs the following duties:
(1) Carrying out research on medical device standards, and proposing opinions on standard development plans and standard systems in the professional field;
(2) Responsible for the organization of drafting, soliciting opinions, and technical review of medical device standards in the professional field, and be responsible for the technical content and quality of the standards;
(3) To undertake the technical guidance of medical device standards in the professional field and assist in solving technical problems in the implementation of the standards;
(4) Responsible for collecting and sorting out the medical device standard data in the professional field, and establishing technical files;
(5) Responsible for the follow-up evaluation of the implementation of medical device standards in the professional field;
(6) Responsible for the consultation and interpretation of the technical content of medical device standards in the professional field;
(7) To undertake the publicity, training, academic exchanges and related international standardization activities of medical device standards in the professional field.
Article 13 In professional technical fields that cannot be covered by the existing medical device standardization technical committee, the State Food and Drug Administration may determine the medical device standardization technology focal point in accordance with the regulatory requirements and procedures. The standardization technology authority shall carry out the work of medical device standards in the corresponding fields with reference to the responsibilities and relevant regulations of the Medical Device Standardization Technical Committee.
Article 14 The local food and drug supervision and administration department shall perform the following duties in accordance with the law in its administrative area:
(1) Organizing and implementing the laws and regulations on the management of medical device standards;
(2) Organizing and participating in the work related to the formulation and revision of medical device standards;
(3) Supervise the implementation of medical device standards;
(4) Collect and report problems in the standard implementation process to the higher-level food and drug regulatory authority.
Article 15 Medical device research and development institutions, production and operation enterprises and users shall strictly implement the mandatory standards for medical devices.
Encourage medical device research and development institutions, production and operation enterprises and users to actively develop and adopt medical device recommendation standards, actively participate in the formulation and revision of medical device standards, and promptly report medical device standard implementation issues to relevant departments and put forward suggestions for improvement.
Chapter III Standard Formulation and Revision
Article 16 The procedures for the formulation and revision of medical device standards include standard project establishment, drafting, soliciting opinions, technical review, approval and release, review and abolition, etc. The specific regulations are formulated by the State Food and Drug Administration.
The standards that are urgently needed for medical device supervision can be developed in accordance with the rapid procedures prescribed by the State Food and Drug Administration.
Article 17 The Medical Device Standards Management Center shall publicly solicit proposals for the establishment and revision of medical device standards based on the medical device standard planning.
For the solicited project proposal, the corresponding medical device standardization technical committee (including the standardization technology focal point, the same below) will conduct research and submit an application for the standard plan project in the professional field.
Involving two or more medical device standardization technical committees, the standard plan project proposal should be coordinated by the medical device standard management center, determine the lead medical device standardization technical committee, and submit an application for the standard plan project.
Article 18 The Medical Device Standards Management Center puts forward the medical device standard plan project after publicly soliciting opinions and organizing experts to discuss the application for the medical device standard plan project, prepares the annual work plan for standard formulation and revision, and submits it to the State Food and Drug Administration Audited by the General Administration.
The medical device standard plan items approved by the State Food and Drug Administration shall be made public. The national standard plan project is sent to the State Council's administrative department of standardization for approval and issuance; the industry standard plan project is approved and dispatched by the State Food and Drug Administration.
Article 19 Medical device production and operation enterprises, users, regulatory agencies, testing institutions, and relevant educational and scientific research institutions, social organizations, etc., may submit applications for drafting relevant medical device standards to the Medical Device Standardization Technical Committee undertaking the medical device standard plan project . The Medical Device Standardization Technical Committee selects the drafting unit based on the principles of openness, fairness, and selection based on the technical content of the standard.
The drafting unit shall conduct extensive research, in-depth analysis and research, actively learn from relevant international standards, draft medical device standards on the basis of full verification of technical content, and form a draft of medical device standards for comments. After preliminary review by the Medical Device Standardization Technical Committee, report Sent to the Medical Device Standards Management Center.
Article 20 The draft of medical device standards is open to the public for comments on the website of the Medical Device Standards Management Center. The period for soliciting comments is generally two months. The Medical Device Standardization Technical Committee undertaking the medical device standard plan project summarizes the collected opinions and feeds them back to the standard drafting unit. The drafting unit shall carefully study the summary opinions, revise and improve the draft for comments, and form a medical device standard delivery Reviewer.
Article 21 The Medical Device Standardization Technical Committee undertaking the medical device standard plan project is responsible for organizing the technical review of the medical device standard submission draft. After the review is passed, the medical device standards are submitted for approval, implementation suggestions and related materials to the Medical Device Standards Management Center for review.
Article 22 The Medical Device Standards Management Center shall submit the approved medical device standards for approval and the review conclusions to the State Food and Drug Administration for review. The approved national standards for medical devices shall be submitted to the State Council’s administrative department for standardization for approval and release; the approved medical device industry standards shall be issued by the State Food and Drug Administration to determine the implementation date and requirements for implementation.
The national standards and industry standards for medical devices shall be made public in accordance with the relevant regulations of the administrative department of standardization under the State Council for public inspection.
Article 23 After the medical device standard is approved and issued, if individual technical content affects the use of the standard and needs to be modified, or a small amount of addition or reduction is made to the original standard content, the standard modification form shall be adopted. The standard revision list shall be formulated in accordance with the standard formulation and revision procedures, and be reviewed and issued by the original approval department of the medical device standard.
Article 24 The Medical Device Standardization Technical Committee shall conduct a review of the published and implemented medical device standards, organize a timely review of its effectiveness, applicability and advancement in accordance with scientific and technological progress, industrial development and regulatory needs, and propose a review conclusion . The review conclusions are divided into continued validity, revision or repeal. In principle, the review period shall not exceed 5 years.
After the medical device standard review conclusion is approved by the Medical Device Standards Management Center, it shall be submitted to the State Food and Drug Administration for review. The review conclusion of the national medical device standard shall be sent to the State Council’s administrative department of standardization for approval; the review conclusion of the medical device industry standard shall be reviewed and approved by the State Food and Drug Administration, and the review conclusion shall be announced in the form of an announcement.
Chapter IV Standard Implementation and Supervision
Article 25 Medical device enterprises shall organize production in strict accordance with the registered or filed product technical requirements, and ensure that the medical devices that leave the factory meet the mandatory standards and the registered or filed product technical requirements.
Article 26 The content of the recommended standards for medical devices cited in laws and regulations, regulatory documents, and registered or filed product technical requirements shall be enforced.
Article 27 The technical requirements for medical device products shall be compatible with the product design characteristics, intended use and quality control level, and shall not be lower than the mandatory national standards and mandatory industry standards applicable to the products.
Article 28 The food and drug supervision and administration department shall supervise and inspect the implementation of the mandatory medical device standards and the registered or filed product technical requirements by medical device companies.
Article 29 Any unit or individual has the right to report or report violations of mandatory medical device standards and registered or filed technical requirements to the Food and Drug Administration. The department that receives the report or report shall promptly deal with it in accordance with regulations.
Article 30 The medical device standards shall be managed in an informatized manner, and information on the establishment, release and implementation of the standards shall be disclosed to the public in a timely manner.
Article 31 The food and drug supervision and administration department shall organize and guide the publicity and training of the standards in a timely manner after the release of the medical device standards.
Article 32 The Medical Device Standardization Technical Committee will follow up and evaluate the implementation of the standard. The Medical Device Standards Management Center conducts statistical analysis on the implementation of mandatory standards based on the follow-up evaluation.
Chapter V Supplementary Provisions
Article 33: The serial numbers of national standards for medical devices shall be compiled in accordance with the regulations of the administrative department of standardization under the State Council. The code name of the medical device industry standard is composed of uppercase Chinese pinyin letters. The code name of the mandatory industry standard is "YY", and the code name of the recommended industry standard is "YY/T".
The serial number of the industry standard is composed of the code name of the industry standard, the standard number and the year number of the standard release. The format is: YY ××××1-××××2 and YY/T ××××1-××××2.
××××1 is the standard number, and ××××2 is the standard issue year number.
Article 34 Social organizations established in accordance with the law may formulate and publish group standards. The management of group standards shall comply with relevant national regulations.
Article 35 Medical device standard samples are physical standards in the inspection and testing of medical devices, and their management shall comply with relevant national regulations.
Article 36 These Measures shall come into force on July 1, 2017. The "Administrative Measures for Medical Device Standards (Trial)" (formerly Order No. 31 of the State Drug Administration) promulgated on January 4, 2002 shall be repealed simultaneously.
