Chapter I General Provisions
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 the safety of medical care, 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, statutes, and regulations. The formulation of this approach.
Article 2
The medical technology referred to in these Measures refers to the diagnostic and therapeutic measures taken by medical institutions and their medical staff for the purpose of diagnosing and treating diseases, making judgments about diseases and eliminating them, alleviating the conditions, alleviating the pains, improving the functions, prolonging the lives, and helping the patients to regain their health.
Article 3
Medical institutions to carry out clinical application of medical technology shall comply with these measures.
Article IV
The clinical application of medical technology shall follow the principles of science, safety, standardization, effectiveness, economy and ethics.
Medical institutions to carry out medical technology should be compatible with its function and mission, with qualified professionals and technicians, the corresponding equipment, facilities and quality control system, and comply with technical management standards.
Article 5
The state establishes a system of access to and management of the clinical application of medical technology, and carries out categorization 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 Grading 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 Class III 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 type of medical technology management.
The second category of medical technology catalog by the provincial health administrative departments in accordance with 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 10
The clinical application of the first category of medical technology shall be strictly managed by the medical institutions in accordance with their functions, tasks and technical capabilities.
Article 11
Medical institutions shall, in accordance with the law, allow medical personnel to implement medical technology appropriate to their professional capabilities.
Article XII
Medical institutions to carry out clinical testing programs must be published by the Ministry of Health to carry out clinical testing programs.
Article 13
Medical institutions shall not apply in the clinical application of the Ministry of Health abolished or prohibited the use of medical technology.
Chapter III of the ability to review the clinical application of medical technology
Article 14
The third category of medical technology for the first time before the application of the clinic, must be organized by the Ministry of Health of the safety, effectiveness of clinical trials, research, demonstration and ethical review.
Article 15
The second category of medical technology and the third category of medical technology before the clinical application of third-party technical review system.
The technical audit of the ability of medical personnel to carry out the clinical application of the first category of medical technology, organized by the medical institutions themselves, or by the provincial health administrative department.
Article 16
The Ministry of Health designated or formed by the agency, organization (hereinafter referred to as the technical audit agency) is responsible for the third category of clinical application of medical technology competence technical audit.
Provincial health administrative departments to designate or set up the technical review organization is responsible for the second category of medical technology clinical application of the ability to technical review.
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 17
The technical review body shall meet the following conditions:
(1) a sound organizational structure and a sound management system;
(2) authority in the field of medical specialty;
(3) scientific, rigorous and standardized academic style;
(4) provincial or higher administrative departments of health regulations Other conditions.
Article 18
The technical auditing organization shall establish an auditing work system, develop and publish the technical auditing procedures for the clinical application of medical technology, and establish an expert pool according to 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 auditing organization shall be composed of persons in the fields of medicine, jurisprudence, ethics, and management, and shall meet the following conditions:
(1) be familiar with and have a good grasp of the relevant laws, rules and regulations;
(2) have a good professional moral character, professional knowledge, and business ability;
(3) be employed In medical and health institutions, colleges and universities, scientific research institutions or legal service organizations, and hold the corresponding senior professional and technical positions for more than three years;
(d) health status is able to evaluate the work;
(e) other conditions prescribed 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
The members of the expert pool to participate in the technical review of the implementation of the avoidance system and accountability system.
Article 21
Medical institutions to carry out the second category of medical technology or the third category of medical technology, shall apply to the appropriate technical review organization for the 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 is in line with the planning of the relevant health administrative department;
(b) there are corresponding diagnostic and therapeutic subjects approved by the administrative department of health;
(c) there are in the organization registered, competent in the 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 the management system and quality assurance measures related to the medical technology;
(ix) other conditions specified by the provincial health administrative departments.
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 the clinical application of medical technology, including:
(a) the name, level, type, registration of the corresponding diagnostic and treatment subjects, the corresponding departmental setup;
(b) the purpose and significance of carrying out the medical technology and implementation plan;
(c) the medical technology of the purpose
(3) 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 for the diagnosis and treatment of the same disease, risk, efficacy, cost, and duration of the course of the comparison;
(4) to carry out the conditions for the medical technology
(d) the conditions under which the medical technology is carried out, including the registration, qualification and curriculum vitae of the main technical personnel, equipment, facilities, other auxiliary conditions, risk assessment and emergency plans of the medical institution;
(e) the report of the medical ethical review of the institution;
(f) other issues that need to be clarified.
Article 23
Where any of the following circumstances exists, a medical institution shall not submit an application for technical audit of the clinical application capability of medical technology to the technical auditing organization:
(1) the medical technology applied for is abolished or prohibited from being used by the Ministry of Health;
(2) the medical technology applied for has not been listed in the corresponding catalog;
(3) the medical technology applied for is not yet available from the last time the same medical technology was applied for. Medical technology from the last time the same medical technology did not pass the technical audit of clinical application capabilities of less than 12 months;
(D) the provincial health administrative department of other circumstances.
Article 24
Failure 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
Technical audit institutions received medical institutions clinical application of medical technology ability to audit the application, for the conditions, shall be accepted, and from the date of acceptance of 30 days, the organization of the relevant professional experts in accordance with the audit procedures and medical technology management specifications, the medical institution for the ability to conduct a technical audit of the clinical application of medical technology and technical audit report issued. Audit report.
Article 26
The technical audit organization may, according to the needs of its work, obtain information from the persons concerned or verify the situation on the spot.
Article 27
The conclusions of the technical audit of the clinical application of medical technology are subject to a collegial system. Participate in the clinical application of medical technology, the number of technical audit shall be more than three singular, each auditor independently issued a written audit opinion and signature.
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 responsible for the audit conclusions.
Article 28
Technical review body shall make the audit conclusions within 10 days from the date of the audit conclusions, the audit conclusions will be sent to the applicant medical institutions.
Article 29
Technical review organization shall be the clinical application of medical technology application materials, audit members of the written audit comments, audit members of the information, audit conclusions and other materials to be permanently stored.
Article 30
Technical review organization to carry out technical audit can be charged in accordance with the provisions of the relevant fees.
Article 31
The technical audit organization shall report the results of the audit to the appropriate health administrative department.
Technical review 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 at the specified time, the administrative department of health will no longer be designated to undertake the technical audit work.
Chapter IV Management of Clinical Application of Medical Technology
Article 32
Provincial health administrative departments are responsible for validating the clinical application of the second type of medical technology.
The Ministry of Health is responsible for validating the clinical application of the third category of medical technology.
Article 33
Medical institutions have the following conditions at the same time, the provincial level or above, the administrative department of health may validate its ability to carry out clinical application of medical technology through the technical audit:
(a) the technical audit agency review and agree to the opinion;
(b) there are approved by the administrative department of health registration of the corresponding diagnostic and therapeutic subjects;
(c) The medical technology is compatible with the functions and tasks of medical institutions;
(d) in line with the planning of the corresponding health administrative departments;
(e) other conditions specified by the health administrative departments at or above the provincial level.
Article 34
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 the medical institutions," 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
The health administrative department shall be in the medical institution "medical practice license" copy of the remarks column indicates the corresponding professional diagnostic and therapeutic subjects and their registration under the permitted medical technology, and timely announcement to the community.
Article 36
Medical institutions shall have a special department responsible for the management of the clinical application of medical technology and the first category of clinical application of medical technology ability to technical audit.
Article 37
Medical institutions shall establish a medical technology grading management system and regulations to ensure the quality and safety of the clinical application of medical technology, the establishment of medical technology files, medical technology on a regular basis to assess the safety, effectiveness and rational application of medical technology.
Article 38
Medical institutions shall establish a 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 risk, the process of complexity in general, with a certain degree of technical difficulty of surgery;
Level III surgery refers to a higher risk, the process of complexity, difficulty of surgery;
The surgery of higher risk, complexity, difficulty of surgery;
The surgery of higher risk, complexity, difficulty of surgery. p>Quaternary surgeries are major surgeries with high risk, complexity of process, and difficulty.
Article 39
Medical institutions shall qualify physicians with different professional and technical qualifications to carry out different levels of surgery, and their professional competence after reviewing and granting the appropriate surgical authority.
Article 40
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 of the annual report to the administrative department of health of the clinical application of the clinical application of the situation, including the number of diagnosis and treatment of cases, mastery of the indications, the effectiveness of the clinical application of complications, complications, comorbidities, adverse reactions, follow-up, and so on.
When necessary, the corresponding health administrative department can organize experts to verify on-site.
Article 41
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 the "license to practice in medical institutions":
(a) the medical technology was abolished by the Ministry of Health or prohibited the use of;
(b) the main professional and technical personnel engaged in the medical technology or the health administrative department. (b) the main professional and technical personnel engaged in the medical technology 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 quality of medical care and medical safety hazards;
(e) the medical technology of the ethical defects;
(F) the clinical application of the medical technology is uncertain;
(VII) the provincial health administrative department of other circumstances.
Article 42
Medical institutions in the case of Article 41 (1), (2), the health administrative department responsible for the registration of medical institutions diagnostic and therapeutic subjects shall promptly cancel the registration of medical institutions under the diagnostic and therapeutic subjects of the corresponding medical technology, and to the public announcement.
Article 43
Medical institutions, Article 41 (c), (d), (e), (f) of the situation, the approval of the clinical application of the medical technology of the health administrative department shall immediately organize experts on the clinical application of medical technology in the medical institutions to review the situation. 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
Medical institutions in one of the following circumstances, shall report to the health administrative department that approved the clinical application of the medical technology to decide whether it is necessary to re-examine the technical review of the ability to clinically apply the medical technology:
(a) changes in the professional and technical personnel related to the medical technology, or in the equipment, facilities, and auxiliary conditions, which may bring uncertain consequences to the clinical application of the medical technology. Clinical application of medical technology has uncertain consequences;
(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 more than one year to be carried out again.
Chapter V Supervision and Management
Article 45
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 learn about the situation and to investigate and collect evidence;
(2) to inspect and copy the relevant information;
(3) to order the medical institution to immediately rectify the illegal and illicit behavior.
Article 47
The administrative department of health shall regularly audit 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 in accordance with the provisions of Article 42, 43, to make 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
Medical institutions in violation of the provisions of Article 34 of these Measures, without the registration of medical institutions under the diagnosis and treatment of medical technology 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
Medical institutions in one of the following circumstances, the health administrative department shall 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 in the process of technical audit of the ability to falsify;
(b) does not comply with the corresponding health
(c) Failure to pass the technical audit of clinical application of medical technology;
(d) Exceeding the scope of the registered diagnostic and therapeutic subjects;
(e) Medical technology is not compatible with its functions and tasks;
(f) Although it has passed the audit of clinical application of medical technology, it no longer possesses the conditions for the clinical application of medical technology;
(h) The medical technology is not compatible with its functions and tasks.
(VII) Provincial health administrative departments and other circumstances.
Article 50
Medical institutions in one of the following situations, the health administrative department shall immediately order its correction; causing serious consequences, the medical institution 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) violation of the provisions of Article XIV of the Measures Provisions of the unauthorized clinical application of the new third category of medical technology;
(C) clinical application of medical technology without the ability to clinical application of medical technology technology audit;
(D) not in accordance with the provisions of Article 40 of these Measures to the administrative department of health to report the clinical application of medical technology;
(E) not in accordance with the provisions of Article 41 of the present Measures to stop the immediate clinical application of medical technology. Clinical application;
(F) not in accordance with the provisions of Article 44 of these measures to re-apply for the clinical application of medical technology ability to technical review, or unauthorized clinical application of medical technology needs to be re-examined for the clinical application of medical technology ability to technical review of medical technology;
(VII) violation of the other provisions of these measures.
Article 51
Medical institutions to allow medical personnel beyond their professional ability to carry out medical technology to the patient caused by the damage, the medical institution to bear the corresponding legal and economic compensation responsibility; without the approval of the medical institution, the medical staff unauthorized clinical application of medical technology, by the medical staff to bear the corresponding legal and economic compensation responsibility.
Article 52
Medical institutions and licensed physicians in the clinical application of medical technology in the process of violation of the "Practicing Physicians 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, shall be punished in accordance with the relevant laws and regulations.
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
The technical review body shall participate in the technical review of the expert pool members of the annual assessment of 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 audit work can not be scientific, objective and impartial 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;
(d) in the process of technical auditing, fraud, acceptance of property or make other improper interests;
(E) Provincial or higher health administrative departments stipulate other circumstances.
Article 55
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
Health administrative departments and their staff intervene in the technical audit work in violation of the provisions of 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 situation, shall be given to the person in charge of the relevant and directly responsible for the administrative sanctions.
Chapter VI Supplementary Provisions
Article 57
This approach has been clinically applied before the release of the third category of medical technology, medical institutions should be in accordance with the provisions of this approach within six months after the implementation of this approach to the technical review body to submit a technical review of the ability to clinically apply medical technology technology 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 technical audit and medical technology registration under the diagnosis and treatment subjects by the provincial health administrative departments.
Article 58
Allogeneic stem cell therapy technology, allogeneic gene therapy technology, human somatic cell cloning technology and other medical technology shall not be applied to clinical.
Article 59
Methods for the administration of clinical trials of the third type of medical technology shall be separately formulated by the Ministry of Health.
Article 60
Where laws and regulations have special provisions on the clinical application of medical technology, such provisions shall apply.
Article 61
These Measures shall come into force on May 1, 2009.
Attachment The third category of medical technology directory
I. Medical technology involving major ethical issues, safety and effectiveness still need to be further verified by standardized clinical trial studies: cloning therapy technology, autologous stem cell and immune cell therapy technology, gene therapy technology, central nervous system surgical detoxification, stereotactic surgery to treat mental illness, allogeneic stem cell transplantation technology, tumor seedling therapy technology. , tumor seedling treatment technology, etc.
Two, involving major ethical issues, safety and effectiveness of the exact 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 surgical treatment technology, xenogeneic organ transplantation technology.