Medical network - on April 27, the measures for the administration of medical devices standards on February 21, 2017, the state food and drug supervision and management of the administration, adopted at the meeting examined and approved, are hereby released, and effective as of July 1, 2017.

Chief: bijing spring

On April 17, 2017

Methods of standard management of medical devices

Chapter 1 general rule

Article 1 with a view to promote the progress of science and technology, to ensure the safety of medical equipment effectively, improve the level of health care, to strengthen the standard management of medical equipment, according to the law of the People's Republic of China standardization law "standardization law implementing regulations of the People's Republic of China" and the "regulations on the supervision and administration of medical devices" and other laws and regulations and these measures.

Article 2: for the purposes of these measures, the term "medical device standards is to point to by the state food and drug administration bureau according to duty organization system revision, in accordance with the procedure is issued, in medical equipment development, production, management, use, supervision and management activities such as adhere to the unity of the technical requirements.

Article 3 within the territory of the People's Republic of China engaged in medical equipment standard system revision, implementation and supervision, shall abide by the laws, administrative regulations and provisions of the measures.

Article 4 the standard of medical instruments shall be classified as mandatory and recommended.

The technical requirements for safeguarding human health and life safety shall be formulated for the mandatory national standards and mandatory industry standards for medical devices.

To meet the basic general, supporting and compulsory standards for medical devices industry play a leading role in need of technical requirements, such as medical devices can be formulated as recommended national standards and voluntary industry standards.

Article 5 the standard of medical instruments shall be divided into basic standards, method standards, management standards and product standards.

Article 6 the state administration of food and drug supervision and management of the preparation of medical apparatus and instruments in accordance with the standard planning, build system of medical instrument standard management, improve the standard management system of medical equipment.

Article 7 to encourage enterprises, society, education, scientific research institutions and individuals are widely involved in the standard system revision work of medical equipment, and supervise the implementation of medical instrument standard.

Article 8 participation in international standardization activities shall be encouraged to participate in the formulation and adoption of the standards of international medical instruments.

Article 9 the state administration of food and drug supervision and administration on medical devices standards organizations and individuals that have made remarkable achievements in the work in accordance with the relevant provisions of the state to give praise and reward.

Chapter ii responsibilities of standard management

Article 10 the general administration of food and drug administration of the state shall perform the following duties:

(1) to organize and implement the relevant laws and regulations of the medical device standards, and formulate the standard management system for medical devices;

(2) to organize and formulate standard plans for medical devices; to formulate and revise annual work plans;

(3) to organize and revise the standard system of medical devices according to law and promulgating standards for medical devices;

To guide and supervise the management of medical devices according to law.

Article 11 the state food and drug supervision and management of the administration of medical devices standards management center (hereinafter referred to as the "medical devices standard management center") shall perform the following duties:

(1) to organize and carry out the research of the standard system for medical devices, and formulate the draft of the standard plan for medical devices and the recommendations for the revision of the annual work plan of the standard system;

(2) to undertake the administration of standard revision of medical devices according to law;

(3) to undertake the administration of the standardization technical committee of medical devices according to law;

(4) to be responsible for the organization of the standard publicity and training of medical devices;

(5) to conduct research on the implementation of standards and to coordinate the implementation of major technical problems in the implementation of standards;

(6) to undertake the relevant work of international standardization of medical devices and the exchanges of foreign cooperation;

(7) to undertake the informationization of medical devices and to organize the standard publication of medical devices;

(8) to undertake other standards administration tasks assigned by the state administration of food and drug administration.

Article 12 the state food and drug supervision and administration bureau according to the needs of the medical equipment standardization work, the approved medical equipment standardization technical committee established in accordance with the law.

The standardization technical committee of medical devices shall perform the following duties:

(1) to carry out the standard research work on medical devices, and put forward the standard development plan and standard system opinions of the specialty areas;

(2) to undertake the professional medical equipment standard drafting, for advice, technical review and so on organization work, and shall be responsible for technical content and quality of standard;

(3) to assist in the technical guidance of the standards of medical devices in the field and to assist in solving technical problems in the implementation of standards;

(4) to collect and organize the standard data of medical devices in the field and establish technical archives;

(5) to be responsible for the tracking and evaluation of the implementation of the standards of medical devices in the field;

(6) to be responsible for the consultation and interpretation of the technical contents of medical devices in the specialized areas;

To be responsible for the promotion, training, academic exchanges and related international standardization activities of medical device standards in this specialty area.

Article 13 in the existing medical equipment standardization technical committee fails to cover areas of expertise, the state food and drug administration can need according to the regulation, according to the program to determine medical equipment standardization technology under centralized unit.The standardization technical committee shall carry out the standards of medical devices in the relevant fields by reference to the functions and responsibilities of the standardization technical committee of medical devices.

Article: the local food and drug administration department shall perform the following duties according to law in this administrative area:

(1) to organize and implement the laws and regulations governing the standards of medical devices;

(2) to organize and participate in the revision of the standards for medical devices;

(3) to supervise the implementation of the standards for medical devices;

(4) to collect and to report the problems in the implementation of the standard implementation of the food and drug administration department.

Article 10 the development of medical instruments, production and operation enterprises and use units shall strictly implement the compulsory standards for medical instruments.

Encourage medical research institutions and production management enterprise and unit using positive research and using the recommended standard of medical equipment, actively participate in the standard system revision work of medical equipment, timely feedback to the relevant department medical devices standards implementation problems and improvement Suggestions are put forward.

Chapter iii standards formulation and revision

Article 16 the standard revision procedure for medical devices shall include the standards, drafting, consultation, technical examination, approval, review and repeal.The specific provisions shall be formulated by the state administration of food and drug administration.

The standards for the regulation of medical devices that need to be revised shall be carried out in accordance with the rapid procedures prescribed by the state food and drug administration.

Article 17 of the medical equipment management center shall, according to the medical instrument standard planning, open to the society to collect the medical devices standards formulated or revised project proposal.

To collect the project proposal, by the corresponding medical equipment standardization technical committee (including standardization technology under centralized unit, similarly hereinafter) are studied, put forward the standard in the field of professional planning project application.

Involving two or more than two medical equipment standardization technical committee standard plan project proposal, shall be the standard medical devices management center is responsible for the coordination, determine the leading medical equipment standardization technical committee, and put forward by the standard plan project application.

Article 18 in case the medical equipment management center for medical devices standard plan project application, solicit comments by the public and experts, put forward medical instrument standard project plan, establishment standard annual work plan and revising Suggestions, submitted to the state food and drug administration bureau approval.

The state food and drug administration, the standard plan for medical devices approved by the state administration of food and drug administration, shall be shown to the public.The national standards plan project shall be approved by the standardization administration department under the state council for approval;The industry standard project was approved by the state administration of food and drug administration.

Article 19 medical equipment production enterprise, use the unit, supervisory department, the testing institutions and the relevant education scientific research institutions, social organizations, etc., to bear the medical devices standards plan medical equipment standardization technical committee of the drafting of the relevant standards of medical equipment application is put forward.The standardization technical committee of medical devices combines the standard technical content and selects the drafting unit according to the principle of openness, impartiality and meritocracy.

Drafting unit should be widely research and in-depth analysis and research, actively learn from relevant international standards, on the basis of fully validate the content of the technology to draft the standard of medical equipment, form a standard draft medical apparatus and instruments, the medical equipment standardization technical committee after the preliminary examination, submit the medical devices standards management center.

Article 20 medical instrument standard draft in medical equipment management center website to solicit opinions from the public, for public comment period normally for two months.To undertake the project medical instrument standard plan medical equipment standardization technical committee opinion of solicitation to summarize, feedback to the standard drafting unit, the drafting unit shall make a careful study to collect opinions, to improve the draft form a standard SongShenGao medical apparatus and instruments.

Article 21 for medical instrument standard program of medical equipment standardization technical committee to be responsible for the organization of medical instrument standard SongShenGao technical review.After the examination and approval, the medical device standards should be submitted for approval, the implementation advice and the relevant information are submitted to the standard management center for medical devices.

Article 22 medical instrument standard management center will review through after the examination and approval of medical instrument standard draft and audit conclusion and submitted to the state food and drug administration of management review.National standards for medical devices approved by the state council shall be approved and issued by the department of standardization administration under the state council;The standards for medical devices approved by the state food and drug administration shall be promulgated by the state administration of food and drug administration to determine the implementation date and implementation requirements.

The national standards and industry standards for medical devices shall be made public according to the relevant regulations of the administrative department of standardization under the state council.

Article 23 medical instrument standard approval after the release, due to the need of individual technical content influence standard use, modify, or a small amount of increase or decrease the content of the original standard, shall adopt the standard modified single mode changes.The standard amendment shall be formulated in accordance with the standard revision procedure and shall be reviewed and published by the original approval department of the medical instrument standard.

Article 24 medical equipment standardization technical committee shall the medical devices standards to carry out the review of the implementation of published work, according to the progress of science and technology, industry development and regulation need to its effectiveness, applicability and advancement organization review in time, put forward the review conclusion.The conclusion of the review shall be classified as continuing to be effective, amended or repealed.The review period shall be in principle for no more than five years.

The conclusion of the standard review of medical devices is reviewed by the state administration for food and drug administration after the examination and approval of the medical device standards administration center.The conclusion of the national standards review for medical devices shall be approved by the standardization administration department under the state council;The conclusion of the standard review of the medical device industry shall be reviewed and approved by the state administration of food and drug administration, and shall be issued in the form of an announcement in the form of an annulment of the review conclusion.

Chapter iv standards implementation and supervision

Article 25. The enterprise shall, in strict accordance with the registration or registration of medical equipment products technical requirements of production, to ensure that the factory conform to the compulsory standards of medical equipment and the product technical requirements for registration or registration.

Article 26 the voluntary standards of medical equipment by laws and regulations, regulatory documents and certified or registered product technical requirements of the reference shall be enforced.

Article 27 of the medical equipment product technical requirements, shall be and product design characteristics and intended use and the quality control level, and shall not be lower than the product applicable mandatory national standards and industrial standards.

Article 28 the food and drug supervision and administration department of the medical instrument enterprises implementing compulsory standards of medical equipment and product technical requirements for registration or registration of the supervision and inspection.

Article 29 any unit and individual shall have the right to food and drug supervision and administration departments or the violation of medical apparatus and instruments mandatory standard and the behavior of the product technical requirements for registration or registration.The departments that receive reports or reports shall be dealt with in a timely manner.

Article 30 the standards of medical devices shall be in the management of informationization, and the information of the standards, publication and implementation shall be disclosed to the public in a timely manner.

Article 31 the supervision and administration department of the food and drug administration shall promptly organize and guide the publicity and training of the standards after the publication of the standards of medical devices.

Article 32 the standardization technical committee of medical instruments shall track the implementation of the standard.The standard management center of medical devices shall carry out statistical analysis on the implementation of compulsory standards according to the tracking evaluation.

Chapter v supplementary provisions

Article 33 the number of national standards for medical devices shall be formulated in accordance with the provisions of the department of standardization administration under the state council.The standard code for the medical device industry is made up of the alphabet of capital letters.The mandatory industry standard is code-named "YY" and the recommended industry standard is "YY/T".

The industry standard Numbers are made up of industry standard codes, standard Numbers and the annual Numbers issued by the standard.It's going to be y times x times 1 minus x times 2 and y times y over T times 1 minus x times 1 minus x times 2.

The standard number, x * * * 1, is the standard release date.

Article 34 a social group established in accordance with the law may formulate the standards for the publishing community.The management of the group standards shall meet the relevant provisions of the state.

Article 35 the standard samples of medical instruments shall be the physical standards in the examination and inspection of medical devices, and their management shall be in conformity with the relevant provisions of the state.

Article 36 the present measures shall enter into force as of July 1, 2017.The regulations on standard management of medical devices (trial) issued on January 4, 2002 (the original state drug administration for drug administration) were annulled at the same time.