Chapter I General Principles
Article 1 In order to strengthen the management of the clinical application of medical technology, establish a system of access to and management of medical technology, promote the development of medical science and progress in medical technology, improve the quality of medical care, and safeguard medical safety, in accordance with the "Practicing Physicians Law," "Regulations on the Administration of Medical Institutions," "Regulations on the Handling of Medical Accidents" and other relevant Laws, regulations and rules, the formulation of these measures.
Second Article The medical technology referred to in these Measures refers to medical institutions and their medical staff to diagnose and treat diseases for the purpose of diagnosis and treatment of diseases and make judgments on diseases and eliminating diseases, alleviate the condition, relieve pain, improve the function of prolonging the life of the patient to help patients restore their health and to take diagnostic and therapeutic measures.
Article 3 medical institutions to carry out clinical application of medical technology shall comply with these measures.
Article IV clinical application of medical technology shall follow the principles of science, safety, standardization, effectiveness, economy and ethical.
Medical institutions to carry out medical technology should be compatible with its functions and tasks, with qualified professionals and technicians, the corresponding equipment, facilities and quality control system, and comply with technical management standards.
Article 5 The state establishes the access and management system for the clinical application of medical technology, and implements classification and hierarchical management of medical technology.
Article 6 The Ministry of Health is responsible for the national management of the clinical application of medical technology.
Local health administrative departments at or above the county level are responsible for the supervision and management of the clinical application of medical technology under their jurisdiction.
Chapter II Classification and Graded Management of Medical Technology
Article 7 Medical technology is divided into three categories:
The first category of medical technology refers to the safety and effectiveness of the exact, the medical institutions through routine management in the clinical application of the technology can ensure its safety and effectiveness.
The second category of medical technology refers to the safety and effectiveness of the exact, involving certain ethical issues or high risk, health administrative departments should be controlled and managed medical technology.
The third category of medical technology refers to one of the following circumstances, the health administrative departments need to strictly control the management of medical technology:
(a) involving major ethical issues;
(b) high-risk;
(c) the safety and efficacy of the standardized clinical trials need to be further verified;
(d) the need to use scarce resources;
(v) other medical technologies requiring special management as stipulated by the Ministry of Health.
Article 8 The Ministry of Health is responsible for the management of the clinical application of the third category of medical technology.
The third category of medical technology catalog by the Ministry of Health to develop and publish, and according to the actual situation of clinical application, be adjusted.
Article IX provincial health administrative departments are responsible for the clinical application of the second class of medical technology management.
The second category of medical technology catalog by the provincial health administrative departments in accordance with the circumstances of the jurisdiction to develop and publish, reported to the Ministry of Health for the record.
Provincial health administrative departments shall not include in the catalog of medical technology in the administrative region the medical technology abolished or prohibited by the Ministry of Health.
Article X. The clinical application of the first category of medical technology by the medical institutions in accordance with the function, task, technical ability to implement strict management.
Article XI of the medical institutions shall, in accordance with the law, allow medical personnel to implement their professional ability to adapt to the medical technology.
Article XII of the medical institutions to carry out clinical testing programs must be published by the Ministry of Health to carry out clinical testing programs.
Article XIII of the medical institutions shall not be in the clinical application of the Ministry of Health abolished or prohibited the use of medical technology.
Chapter III Audit of the clinical application of medical technology
Article XIV belongs to the third category of medical technology for the first time before the clinical application, must be organized by the Ministry of Health safety, effectiveness of clinical trials, research, demonstration and ethical review.
Article 15: A third-party technical review system shall be implemented before the clinical application of the second and third categories of medical technologies.
The ability of medical personnel to carry out clinical application of the first category of medical technology technical audit, organized by the medical institutions themselves, can also be provided by the provincial health administrative departments.
Article XVI of the Ministry of Health designated or set up institutions, organizations (hereinafter referred to as the technical audit agency) is responsible for the third category of clinical application of medical technology ability to technical audit.
Provincial health administrative departments designated or formed by the technical audit organization is responsible for the second category of medical technology clinical application of the ability to technical audit.
The Ministry of Health may entrust the provincial health administrative departments to organize the designated third category of medical technology for clinical application of technical audit.
Article XVII of the technical audit institutions shall meet the following conditions:
(1) a sound organizational structure and improve the management system;
(2) authority in the field of medical specialties;
(3) academic style of science, rigorous, standardized;
(4) provincial and above, the health administrative department of the other conditions specified.
Article 18 The technical audit organization shall establish an audit work system, develop and publish the technical audit procedures for the clinical application of medical technology capacity, and establish a pool of experts in accordance with the needs of the work.
Audit work system, procedures and expert pool list submitted to the health administrative department designated to undertake technical audit work for the record.
Article 19 The members of the expert pool of the technical audit organization shall be composed of medical, legal, ethical, management and other aspects of the personnel, and meet the following conditions:
(1) familiarity with, and mastery of, the relevant laws, rules and regulations;
(2) good professional ethics, professional knowledge and business ability;
(3) employed in health care institutions
(c) employed in medical and health institutions, institutions of higher learning, scientific research institutions or legal service organizations, and has held the corresponding senior professional and technical positions for more than three years;
(d) health condition is capable of evaluating the work;
(e) other conditions stipulated by the health administrative departments at or above the provincial level.
Technical review organizations to hire the above people into the expert pool can be exempted from administrative restrictions.
Article 20 of the expert pool members to participate in the technical review of the implementation of the avoidance system and accountability system.
Article 21 of the medical institutions to carry out the second category of medical technology or the third category of medical technology, should be applied to the appropriate technical review organization for clinical application of medical technology ability to technical review. Medical institutions that meet the following conditions may apply to the technical review organization for technical review of the clinical application of medical technology:
(a) the medical technology in line with the planning of the corresponding health administrative departments;
(b) the corresponding diagnostic and treatment subjects approved by the administrative department of health;
(c) there are registered in the organization, capable of clinical application of medical technology of the (d) equipment, facilities and other auxiliary conditions appropriate to the development of the medical technology;
(e) the medical technology through the organization's medical ethics review;
(f) the completion of the corresponding clinical trial studies, with safe and effective results;
(g) the last three years of the relevant business has no adverse records;< /p>
(viii) have a management system and quality assurance measures related to the medical technology;
(ix) other conditions specified by the health administrative departments at or above the provincial level.
Article 22 When a medical institution applies for a technical audit of the clinical application of medical technology, it shall submit a report on the feasibility of clinical application of medical technology, including:
(1) the name of the medical institution, level, type, registration of the corresponding diagnostic and therapeutic subjects, and the corresponding departmental setup;
(2) the purpose, significance, and implementation plan for the development of medical technology;
(3) the medical institution shall submit a report on the feasibility of clinical application of medical technology. (C) the basic overview of the medical technology, including domestic and international applications, indications, contraindications, adverse reactions, technical routes, quality control measures, efficacy standards, assessment methods, and other medical technology to diagnose and treat the same disease risk, efficacy, cost and duration of treatment comparison;
(D) the conditions for the development of the medical technology, including (d) the conditions for carrying out the medical technology, including the registration status of the main technical personnel, qualifications, curriculum vitae, equipment, facilities, other auxiliary conditions of the medical institution, risk assessment and contingency plans;
(e) the institution's medical ethical review report;
(f) other issues that need to be clarified.
Article 23 of the following circumstances, the medical institution shall not submit to the technical review body for technical review of the clinical application of medical technology capacity technology review application:
(a) the application of medical technology is the Ministry of Health abolished or prohibited the use of;
(b) the application of medical technology is not included in the corresponding catalog;
(c) the application of medical technology distance from the last time the The same medical technology did not pass the clinical application of the ability to technical audit time is less than 12 months;
(D) the provincial health administrative department stipulates other circumstances.
Article 24 fails to pass the audit of medical technology, medical institutions shall not apply to other technical review body within 12 months of the clinical application of the same medical technology ability to re-audit.
Article 25 of the technical audit institutions received medical institutions clinical application of medical technology ability to audit the application of technology, for compliance with the prescribed conditions, shall be accepted, and from the date of acceptance of 30 days, the organization of relevant professional experts in accordance with the audit procedures and medical technology management specifications, the medical institution for the clinical application of medical technology ability to audit the technology, and issue a technical audit report.
Article 26 The technical audit organization may, according to the needs of the work, to the relevant personnel to understand the situation or to the scene to verify the situation.
Article 27 of the clinical application of medical technology ability to audit the technical findings of the implementation of collegiality. Participate in the clinical application of medical technology, the number of technical audit should be more than three people singular, each auditor independently issued a written audit opinion and signed.
Technical audit organization based on more than half of the audit staff to form technical audit conclusions. Technical audit organization should make a complete record of the audit process and retained for inspection, the reviewer's review of the audit opinions and audit conclusions should be noted.
Technical audit organization shall ensure that the technical audit work of science, objectivity, impartiality, and is responsible for the audit conclusions.
Article 28 of the technical review body shall make the audit conclusions within 10 days from the date of the audit conclusions will be sent to the applicant's medical institution.
Article 29 The technical review organization shall be the clinical application of medical technology application materials, audit members of the written audit, audit member information, audit conclusions and other materials to be permanently preserved.
Article 30 of the technical audit organization to carry out technical audits can be charged in accordance with the provisions of the relevant fees.
Article 31 of the technical audit organization shall report the results of the audit of the corresponding health administrative departments.
Technical auditing organization to designate its annual technical audit work to the administrative department of health to report on the annual technical audit work; failure to report the annual work in the prescribed time, the administrative department of health is no longer designated to undertake the technical audit work.
Chapter IV Management of Clinical Application of Medical Technology
Article 32 The provincial health administrative departments are responsible for validating the clinical application of the second class of medical technology.
The Ministry of Health is responsible for validating the clinical application of the third category of medical technology.
Article 33 of the medical institutions have the following conditions at the same time, the provincial level or above, the administrative department of health can be validated to carry out through the clinical application of the ability to audit the medical technology:
(a) the technical audit organization review and concur with the opinion;
(b) approved by the administrative department of health and the registration of the corresponding diagnostic and therapeutic subjects;
(c) that the medical technology is compatible with the function and mission of the medical institution. (C) the medical technology and medical institutions function, mission compatible;
(D) in line with the corresponding health administrative department of the planning;
(E) provincial or higher health administrative departments stipulate other conditions.
Article 34 of the medical institutions to carry out through the clinical application of the ability to audit the technology of medical technology, by the corresponding administrative department of health within 30 days after the validation of the health administrative department for the issuance of its "license to practice in medical institutions" of the administrative department of health for the registration of medical technology under the diagnosis and treatment subjects. After registration of medical institutions can be applied in the clinical application of the corresponding medical technology.
Article 35 of the administrative department of health shall be in the medical institutions, "medical practice license" copy of the remarks column indicates the corresponding professional diagnostic and treatment subjects and their registration under the permitted medical technology, and timely announcement to the community.
Article 36 of the medical institutions shall have a special department responsible for the management of clinical application of medical technology and the first category of clinical application of medical technology ability to technical audit.
Article 37 of the medical institutions shall establish medical technology grading management system and safeguard the quality of clinical application of medical technology, safety regulations, the establishment of medical technology files, medical technology on a regular basis for the safety, effectiveness and rational application of the assessment.
Article 38 of the medical institutions shall establish surgical grading management system. According to the different degrees of risk and difficulty, surgery is divided into four levels:
Level I surgery refers to low risk, simple process, low technical difficulty of ordinary surgery;
Level II surgery refers to a certain level of risk, the process of complexity in general, with a certain degree of technical difficulty;
Level III surgery refers to the risk of a higher, more complex, more difficult surgery;
Three-level surgery refers to higher risk, more complex, difficult surgery;
Three-level surgery refers to higher risk, more complex, difficult surgery. p>Quaternary surgeries are major surgeries with high risk, complexity of process, and difficulty.
Article 39 of the medical institutions shall have different professional and technical qualifications of physicians to carry out different levels of surgery to limit, and its professional ability to review the corresponding surgical authority granted.
Article 40 of the medical institutions shall be allowed to carry out the second category of medical technology and the third category of medical technology within two years from the date of approval of the clinical application of the medical technology to the health administrative department of the clinical application of the report each year, including the number of diagnosis and treatment of cases, mastery of the indications, the effectiveness of the clinical application of complications, comorbidities, adverse reactions, follow-up, etc..
When necessary, the corresponding health administrative department can organize experts to verify on-site.
Article 41 of the medical institutions in the clinical application of medical technology in the process of one of the following circumstances, shall immediately stop the clinical application of the medical technology, and report to the administrative department of health to issue its "license to practice in medical institutions":
(a) the medical technology was abolished by the Ministry of Health or prohibited the use of;
(b) engaged in this medical technology The main professional and technical personnel or key equipment, facilities and other auxiliary conditions have changed, can not be normal clinical application;
(C) the occurrence of serious adverse consequences directly related to the medical technology;
(D) the medical technology of the existence of hidden dangers in the quality of medical care and medical safety;
(E) the existence of ethical flaws in the medical technology;
(F) the effect of the clinical application of the medical technology. (F) the clinical application of the medical technology is uncertain;
(VII) the provincial health administrative department of other circumstances.
Article 42 of the medical institutions appear Article 41 (a), (b) of the situation, the medical institutions responsible for the registration of medical subjects of the health administrative department shall promptly cancel the medical institutions under the diagnosis and treatment of medical subjects of the corresponding medical technology registration, and to the public announcement.
Article 43 of Article 41 (c), (d), (e), (f) of the situation, the approval of the clinical application of medical technology health administrative department shall immediately organize experts to review the clinical application of medical technology in medical institutions. If necessary, can be organized to demonstrate the safety and effectiveness of medical technology. According to the results of the review and the conclusion of the demonstration, the approval of the clinical application of the medical technology of the health administrative department to make a timely decision to continue or stop the clinical application of the medical technology, and the corresponding medical technology catalog adjustment.
Article 44 of the medical institutions in one of the following circumstances, shall report to the health administrative department for approval of the clinical application of the medical technology to decide whether it is necessary to re-examine the ability of clinical application of medical technology technology technology:
(a) with the medical technology related to the professional and technical personnel, or equipment, facilities, aids to changes in the conditions may be on the clinical application of medical technology
(b) the medical technology non-critical aspects of the change;
(c) the medical technology diagnostic and treatment subject registration is granted within one year after the clinical application;
(d) the medical technology suspended for more than one year to be carried out again.
Chapter V Supervision
Article 45 of the local health administrative departments at or above the county level shall strengthen the supervision and management of the clinical application of medical technology in medical institutions.
Article 46 When carrying out supervision and inspection, the local health administrative departments at or above the county level shall have the right to take the following measures:
(1) to enter the work site to understand the situation and to investigate and collect evidence;
(2) to inspect and copy the relevant information;
(3) to order the medical institutions to immediately rectify the illegal and illicit behavior.
Article 47 of the health administrative department shall regularly review the clinical application of medical technology in medical institutions. In the regular audit process found in Article 41 of the circumstances, the health administrative department shall, in accordance with the provisions of Article 42, 43, to make whether the medical institutions under the diagnosis and treatment of the medical technology registration, continue or stop the clinical application of the medical technology decision.
Article 48 of the medical institutions in violation of the provisions of Article 34, without the medical institutions under the diagnosis and treatment of medical technology registration in the clinical application of medical technology, by the administrative department of health in accordance with the "Regulations on the Management of Medical Institutions," Article 47 of the provisions of the penalty.
Article 49 of the medical institutions in one of the following circumstances, the health administrative department does not medical institutions under the diagnosis and treatment subjects of medical technology registration; has been granted registration, shall promptly revoke the registration of medical technology:
(a) in the clinical application of medical technology ability to technical audit process of fraud;
(b) does not comply with the corresponding health administrative department planning
(c) failed to pass the technical audit of the clinical application of medical technology capacity;
(d) beyond the scope of the registered diagnostic and therapeutic subjects;
(e) medical technology and its functions and tasks are not appropriate;
(f) although the clinical application of medical technology capacity technical audit, but no longer have the conditions for the clinical application of medical technology;
(VII) Provincial and above, the health administrative department of other circumstances.
Article 50 of the medical institutions in one of the following circumstances, the health administrative department shall immediately order its correction; causing serious consequences, the medical institutions shall be held responsible for the main person in charge and directly responsible personnel:
(a) the clinical application of the Ministry of Health to abolish or prohibit the use of medical technology;
(b) in violation of Article XIV of the provisions of the clinical application of new third-class medical technology without authorization. Application of the new third category of medical technology;
(3) clinical application of medical technology without the ability to clinical application of medical technology technology audit;
(4) not in accordance with the provisions of Article 40 of these measures to the administrative department of health to report to the clinical application of medical technology;
(5) not in accordance with the provisions of Article 41 of these measures to immediately stop the clinical application of medical technology;
(F) not in accordance with the provisions of Article 44 of this approach to re-apply for the clinical application of medical technology ability to technical review, or unauthorized clinical application of medical technology that requires re-examination of the clinical application of medical technology ability to technical review of medical technology;
(G) violation of other provisions of this approach.
Article 51 of the medical institutions to allow medical personnel beyond their professional ability to carry out medical technology to the patient caused by the damage, the medical institutions to bear the corresponding legal and economic liability; without the approval of the medical institutions, the medical staff unauthorized clinical application of medical technology, by the medical staff to bear the corresponding legal and economic liability.
Article 52 medical institutions and physicians in the clinical application of medical technology in the process of violation of the "Medical Practitioners Law", "Regulations on the Administration of Medical Institutions", "Regulations on the Handling of Medical Accidents" and "Regulations on Human Organ Transplantation" and other laws and regulations, in accordance with the relevant laws and regulations shall be punished.
Article 53 of the provincial health administrative departments shall strengthen the technical audit organization technical audit supervision and management. One of the following circumstances of the technical review body, designated to undertake the technical review of the health administrative department shall cancel its technical review body qualification:
(a) through the clinical application of medical technology ability to review the medical institutions do not have the ability to clinically apply medical technology;
(b) beyond the authority of the technical review or beyond the provincial level or above, the administrative department of health announced the Medical technology catalog, the clinical application of medical technology for technical review;
(C) accept the Ministry of Health abolished or prohibited the use of medical technology clinical application of ability to technical review application;
(D) serious violations of the technical review process;
(E) can not be in accordance with the provisions of this Measures to complete the technical review work;
(F) provincial level Above the health administrative department of other circumstances.
Technical review body in the first (a), (b), (c), (d) audit conclusions made under the circumstances, the administrative department of health does not approve the clinical application of medical technology and diagnostic and treatment of medical institutions under the basis of registration of medical technology; has been approved for registration, the administrative department of health shall be revoked in a timely manner.
Article 54 of the technical review body shall participate in the technical review of the expert pool members of the annual assessment, the annual assessment failed or found to have one of the following circumstances, the cancellation of its membership of the expert pool, no longer be employed within five years to undertake the technical review of the work, and timely notification of its unit and the designated technical review body of the health administrative department:
(a) In the technical review work can not scientifically and objectively. (a) in the technical audit work can not scientifically, objectively and impartially put forward the evaluation opinion;
(b) serious violations of the technical audit procedures;
(c) can not be completed in accordance with the provisions of this approach to the technical audit work;
(d) in the process of technical auditing, fraud, acceptance of property or make other improper interests;
(e) provincial level Above the health administrative department stipulates other circumstances.
Article 55 of the technical review body staff in the technical review process, abuse of power, falsification or illegal acceptance of property and other improper interests, the technical review body shall be prohibited from participating in the technical review work, and by their units to give administrative sanctions. The technical auditing organization shall not be reappointed within five years to participate in technical auditing work.
Article 56 The health administrative department and its staff in violation of the provisions of the intervention in the technical audit work, the higher health administrative department or the staff of the health administrative department shall be corrected in a timely manner; the consequences of the seriousness of the person in charge of the relevant shall be given and the personnel directly responsible for administrative sanctions.
Chapter VI Supplementary Provisions
Article 57 Before the release of these measures have been clinically applied to the third category of medical technology, medical institutions should be in accordance with the implementation of these measures within six months after the implementation of the provisions of these measures to the technical review body to submit a technical review of the ability to clinically apply medical technology technology application application technology applications. In the implementation of these measures within six months after the application for technical audit or health administrative department decided not to diagnosis and treatment subjects under the medical technology registration, all stop the clinical application of the third category of medical technology.
This approach has been clinically applied before the release of the first category of medical technology and the second category of medical technology clinical application of the ability to audit the technology and medical technology registration under the diagnosis and treatment subjects by the provincial health administrative departments.
Article 58 of the xenogeneic stem cell therapy technology, xenogeneic gene therapy technology, human somatic cell cloning technology and other medical technology shall not be applied to clinical.
Article 59 of the third category of medical technology clinical trial management measures shall be formulated separately by the Ministry of Health.
Article 60 The laws and regulations on the clinical application of medical technology has special provisions, from its provisions.
Article 61 The Measures shall come into force on May 1, 2009.
Attachment
The third category of medical technology catalog
I. involves major ethical issues, safety and effectiveness of medical technology still need to be further verified by the standardization of clinical trial studies: cloning technology, autologous stem cell and immune cell therapy technology, gene therapy technology, central nervous system surgical detoxification, stereotactic surgery for the treatment of psychiatric technology, allogeneic stem cell transplantation technology, tumor seedling treatment technology, etc.
Second, involving major ethical issues, safety and effectiveness of medical technology: homologous organ transplantation technology, sex reassignment surgery.
Third, high risk, safety, effectiveness still need to be verified or safety, effectiveness of medical technology: the use of particle generating devices and other large-scale instrumentation to implement destructive treatment technology, radioactive particle implantation therapy, tumor thermotherapy, tumor cryotherapy, tissue, cell transplantation, artificial heart implantation, artificial intelligence-assisted diagnostic and therapeutic techniques.
Four, other medical technology requires special management: gene chip diagnosis and treatment technology, broken bone heightening surgery and treatment technology, xenogeneic organ transplantation technology.