Chapter I General Principles
Article 1 In order to strengthen the management of clinical application of medical technology, establish a medical technology access and management system, promote the development of medical science and medical technology, improve medical quality and ensure medical safety, these Measures are formulated in accordance with the Law on Medical Practitioners, Regulations on the Administration of Medical Institutions, Regulations on the Handling of Medical Accidents and other relevant laws, regulations and rules.
Article 2 The term "medical technology" as mentioned in these Measures refers to the diagnostic and therapeutic measures taken by medical institutions and their medical staff for diagnosing and treating diseases, judging the condition, relieving the condition, relieving the pain, improving the function, prolonging the life and helping patients recover.
Article 3 Medical institutions shall abide by these Measures when carrying out clinical application of medical technology.
Article 4 The clinical application of medical technology shall follow the principles of science, safety, standardization, effectiveness, economy and ethics.
Medical institutions should adapt to their functions and tasks, have qualified professional and technical personnel, corresponding equipment and facilities and quality control system, and abide by technical management norms.
Article 5 The State establishes a system of access and management of clinical application of medical technology, and implements classified and graded management of medical technology.
Article 6 The Ministry of Health is responsible for the management of clinical application of medical technology throughout the country.
The local health administrative departments at or above the county level shall be responsible for the supervision and management of the clinical application of medical technology in their respective jurisdictions.
Chapter II Classification and Graded Management of Medical Technology
Seventh medical technology is divided into three categories:
The first kind of medical technology refers to the technology that medical institutions can ensure clear safety and effectiveness in clinical application through routine management.
The second kind of medical technology refers to the medical technology that is safe and effective, involves certain ethical issues or has high risks, and should be controlled and managed by the health administrative department.
The third kind of medical technology refers to the medical technology that needs strict control and management by the health administrative department under any of the following circumstances:
(a) involving major ethical issues;
(2) high risk;
(3) Safety and effectiveness need to be further verified by standardized clinical trials;
(4) Need to use scarce resources;
(5) Other medical technologies that require special management as stipulated by the Ministry of Health.
Article 8 The Ministry of Health shall be responsible for the management of the clinical application of category III medical technology.
The third category of medical technology catalogue is formulated and published by the Ministry of Health, and adjusted according to the actual situation of clinical application.
Article 9 The provincial health administrative department shall be responsible for the management of clinical application of category II medical technology.
Category II medical technology catalogue shall be formulated and published by the provincial health administrative department according to the local conditions and reported to the Ministry of Health for the record.
The provincial health administrative department shall not include the medical technology abolished or prohibited by the Ministry of Health in the medical technology catalogue of this administrative region.
Article 10 Medical institutions shall, according to their functions, tasks and technical capabilities, strictly manage the clinical application of Class I medical technologies.
Article 11 Medical institutions shall allow medical personnel to implement medical technology that is suitable for their professional ability according to law.
Twelfth clinical trial projects carried out by medical institutions must be approved by the Ministry of Health.
Thirteenth medical institutions shall not apply medical technology abolished or prohibited by the Ministry of Health in clinical practice.
Chapter III Audit of Clinical Application Ability of Medical Technology
Article 14 Before the first clinical application of Class III medical technology, it must undergo clinical trial research, demonstration and ethical review of safety and effectiveness organized by the Ministry of Health.
Fifteenth class II and class III medical technologies shall be subject to the third-party technology audit system before clinical application.
The technical review of medical personnel's ability to carry out the clinical application of the first type of medical technology shall be organized and implemented by medical institutions themselves, and may also be stipulated by the provincial health administrative department.
Sixteenth institutions and organizations designated or established by the Ministry of Health (hereinafter referred to as technical audit institutions) are responsible for the technical audit of the clinical application ability of the third kind of medical technology.
The technical audit institution designated or established by the provincial health administrative department is responsible for the technical audit of the clinical application ability of the second kind of medical technology.
The Ministry of Health may entrust the provincial health administrative department to organize a technical review of the clinical application ability of the designated tertiary medical technology.
Seventeenth technical audit institutions shall meet the following conditions:
(1) Having a sound organizational structure and management system;
(2) Being authoritative in the medical field;
(3) The style of study is scientific, rigorous and standardized;
(4) Other conditions stipulated by the health administrative department at or above the provincial level.
Eighteenth technical audit institutions shall establish the audit system, formulate and publish the technical audit procedures for the clinical application ability of medical technology, and establish an expert database according to the needs of the work.
The audit work system, procedures and expert database list shall be reported to the health administrative department designated to undertake technical audit work for the record.
Nineteenth members of the expert database of technical audit institutions shall be composed of medical, legal, ethical and management personnel, and meet the following conditions:
(a) familiar with and master the relevant laws, regulations and rules;
(2) Having good professional ethics, professional knowledge and professional ability;
(three) employed by medical and health institutions, institutions of higher learning, scientific research institutions, legal service institutions, and served as the corresponding senior professional and technical positions for more than 3 years;
(four) health status can be competent for the evaluation work;
(5) Other conditions stipulated by the health administrative department at or above the provincial level.
Technical audit institutions can hire the above-mentioned personnel to enter the expert database without administrative restrictions.
Twentieth experts to participate in the technical audit work to implement the avoidance system and accountability system.
Twenty-first medical institutions to carry out the second kind of medical technology or the third kind of medical technology shall apply to the corresponding technical audit institutions for technical audit of the clinical application ability of medical technology. A medical institution that meets the following conditions may submit an application for technical evaluation of the clinical application ability of medical technology to the technical evaluation institution:
(a) the medical technology conforms to the planning of the corresponding health administrative department;
(2) Having corresponding diagnosis and treatment subjects approved by the administrative department of health;
(3) Having major professional and technical personnel registered in this institution who are competent for the clinical application of this medical technology;
(4) Having equipment, facilities and other auxiliary conditions suitable for developing medical technology;
(5) The medical technology has passed the medical ethics examination of this institution;
(six) to complete the corresponding clinical trial research, with safe and effective results;
(seven) there is no bad record in the relevant business in the past three years;
(eight) there are management systems and quality assurance measures related to medical technology;
(nine) other conditions stipulated by the administrative department of health at or above the provincial level.
Twenty-second medical institutions to apply for technical audit of clinical application ability of medical technology, it shall submit the feasibility study report of clinical application of medical technology, including:
(a) the name, level and category of the medical institution, the registration of the corresponding diagnosis and treatment subjects, and the setting of the corresponding departments;
(two) the purpose, significance and implementation plan of developing this medical technology;
(3) The basic information of this medical technology, including its application at home and abroad, indications, contraindications, adverse reactions, technical routes, quality control measures, criteria for judging curative effect, evaluation methods, and comparison with other medical technologies in terms of risk, curative effect, cost and course of treatment of the same disease;
(4) Conditions for developing medical technology, including practice registration, qualifications and relevant resumes of major technicians, equipment and facilities of medical institutions and other auxiliary conditions, risk assessment and emergency plans;
(five) the medical ethics review report of this institution;
(six) other issues that need to be explained.
Twenty-third in any of the following circumstances, medical institutions shall not apply to the technical audit institutions for technical audit of the clinical application ability of medical technology:
(1) The medical technology applied for is abolished or prohibited by the Ministry of Health;
(2) The medical technology applied for is not listed in the corresponding catalogue;
(3) It is less than 12 months since the last time that the same medical technology failed the technical audit of clinical application ability;
(4) Other circumstances stipulated by the health administrative department at or above the provincial level.
Twenty-fourth failed medical technology, medical institutions in 12 months shall not apply to other technical audit institutions to re-examine the clinical application ability of the same medical technology.
Article 25 After receiving the application for technical evaluation of the clinical application ability of medical technology in medical institutions, the technical evaluation institution shall accept the application that meets the prescribed conditions, and organize relevant professional experts to conduct technical evaluation of the clinical application ability of medical technology in medical institutions within 30 days from the date of acceptance, and issue a technical evaluation report.
Twenty-sixth technical audit institutions may, according to the needs of their work, know the situation from relevant personnel or go to the scene to verify the relevant situation.
Twenty-seventh medical technology clinical application ability technical audit conclusion to implement collegiate bench system. There should be more than 3 people who participate in the technical audit of clinical application ability of medical technology, and each auditor independently issues a written audit opinion and signs it.
Technical audit institutions form technical audit conclusions according to the opinions of more than half of the auditors. The technical audit institution shall completely record the audit process and keep it for future reference. If the auditor's audit opinion is different from the audit conclusion, it shall be indicated.
Technical audit institutions shall ensure that the technical audit work is scientific, objective and fair, and shall be responsible for the audit conclusions.
Twenty-eighth technical audit institutions shall, from the date of making the audit conclusion 10 days, send the audit conclusion to the medical institution applying for audit.
Twenty-ninth technical audit institutions shall permanently save the application materials for clinical application of medical technology, written audit opinions of audit members, information of audit members, audit conclusions and other materials.
Thirtieth technical audit institutions to carry out technical audit work can be charged in accordance with the provisions of the relevant fees.
Thirty-first technical audit institutions shall report the audit results to the corresponding health administrative departments.
The technical audit institution shall report the annual technical audit work to the health administrative department that designates it to undertake the technical audit work; If the annual work situation is not reported within the specified time, the health administrative department will no longer designate it to undertake the technical audit work.
Chapter IV Management of Clinical Application of Medical Technology
Thirty-second provincial health administrative departments are responsible for the examination and approval of the clinical application of the second kind of medical technology.
The Ministry of Health is responsible for approving the clinical application of the third kind of medical technology.
Thirty-third medical institutions meet the following conditions at the same time, the health administrative department at or above the provincial level may examine and approve the medical technology that has passed the clinical application ability technology audit:
(a) the consent of the technical audit institution;
(2) Having corresponding diagnosis and treatment subjects approved and registered by the health administrative department;
(three) medical technology and medical institutions to adapt to the functions and tasks;
(four) in line with the planning of the corresponding health administrative department;
(5) Other conditions stipulated by the health administrative department at or above the provincial level.
Article 34 A medical institution that has passed the examination and approval of clinical application ability and technology shall, within 30 days after the examination and approval by the corresponding health administrative department, go to the health administrative department that issued its Practice License for Medical Institutions to register the medical technology under the diagnosis and treatment subjects. After registration, medical institutions can apply corresponding medical technology in clinic.
Thirty-fifth health administrative departments should indicate the corresponding professional diagnosis and treatment subjects and approved medical technologies in the remarks column of the copy of the Practice License for Medical Institutions of medical institutions, and make a timely announcement to the public.
Thirty-sixth medical institutions should have a special department responsible for the management of clinical application of medical technology and the technical audit of the clinical application ability of the first class of medical technology.
Thirty-seventh medical institutions should establish the grading management system and rules and regulations of medical technology to ensure the quality and safety of clinical application of medical technology, establish medical technology files, and regularly evaluate the safety, effectiveness and rational application of medical technology.
Thirty-eighth medical institutions should establish a grading management system for surgery. According to the risk and difficulty, the operation is divided into four levels:
First-class operation refers to ordinary operation with low risk, simple process and low technical difficulty;
Secondary operation refers to the operation with certain risks, complicated general process and certain technical difficulties;
The third-level operation refers to the operation with high risk, complex process and great difficulty;
Grade Ⅳ operation refers to a major operation with high risk, complicated process and great difficulty.
Thirty-ninth medical institutions should restrict doctors with different professional and technical qualifications to carry out different levels of surgery, and grant corresponding surgical authority after reviewing their professional ability.
Article 40 A medical institution shall, within 2 years from the date of granting the second and third medical technologies, report the clinical application to the health administrative department that approved the clinical application of the medical technologies, including the number of cases treated, the mastery of indications, the clinical application effect, complications, complications, adverse reactions and follow-up.
When necessary, the corresponding health administrative department may organize experts to conduct on-site verification.
Article 41 If the clinical application of medical technology is under any of the following circumstances, the medical institution shall immediately stop the clinical application of the medical technology and report to the health administrative department that issued the Practice License for Medical Institution:
(1) This medical technology has been abolished or banned by the Ministry of Health;
(two) the main professional and technical personnel engaged in medical technology or key equipment, facilities and other auxiliary conditions have changed, which can not be used normally in clinical practice;
(3) Serious adverse consequences directly related to medical technology;
(four) medical technology has hidden dangers in medical quality and medical safety;
(5) There are ethical defects in medical technology;
(six) the clinical application effect of the medical technology is not exact;
(seven) other circumstances stipulated by the administrative department of health at or above the provincial level.
Article 42 If a medical institution is under the circumstances of Item (1) and Item (2) of Article 41, the health administrative department responsible for the registration of medical institutions' diagnosis and treatment subjects shall cancel the corresponding medical technology registration under the medical institutions' diagnosis and treatment subjects in time and make an announcement to the public.
Article 43 In case of any of the situations mentioned in Item (3), (4), (5) and (6) of Article 41 in a medical institution, the health administrative department that approved the clinical application of the medical technology shall immediately organize experts to review the clinical application of the medical technology in the medical institution. When necessary, the organization can demonstrate the safety and effectiveness of medical technology. According to the results of the review and the conclusion of the demonstration, the health administrative department that approved the clinical application of the medical technology made a timely decision to continue or stop the clinical application of the medical technology, and adjusted the corresponding medical technology catalogue.
Article 44 Under any of the following circumstances, a medical institution shall report to the health administrative department that approved the clinical application of the medical technology to decide whether it is necessary to review the clinical application capability of the medical technology:
(a) the professional and technical personnel or equipment, facilities and auxiliary conditions related to the medical technology have changed, which may bring uncertain consequences to the clinical application of the medical technology;
(2) The non-critical links of medical technology have changed;
(3) The medical technology has not been applied in clinical practice within 1 year after the registration of medical technology diagnosis and treatment subjects;
(4) Medical technology has been suspended for more than 1 year and is planned to be re-developed.
Chapter V Supervision and Administration
Forty-fifth 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.
Forty-sixth health administrative departments at or above the county level shall have the right to take the following measures when conducting supervision and inspection:
(a) to enter the work site to understand the situation and investigate and collect evidence;
(two) to consult and copy the relevant information;
(3) Ordering medical institutions to immediately correct illegal acts.
Forty-seventh health administrative departments should regularly review the clinical application of medical technology in medical institutions. In the process of regular audit, it is found that there are circumstances stipulated in Article 41 of these measures, and the administrative department of health shall, in accordance with the provisions of Article 42 and Article 43 of these measures, make a decision on whether to cancel the registration of the medical technology under the diagnosis and treatment subjects of medical institutions, and continue or stop the clinical application of the medical technology.
Article 48 If a medical institution, in violation of the provisions of Article 34 of these measures, applies medical technology that has not been registered as a medical technology subject of medical institutions to clinical practice, the administrative department of health shall punish it in accordance with the provisions of Article 47 of the Regulations on the Administration of Medical Institutions.
Forty-ninth medical institutions in any of the following circumstances, the administrative department of health shall not register the medical technology under the medical subjects of medical institutions; If registration has been granted, the registration of medical technology shall be revoked in time:
(a) practicing fraud in the process of technical audit of clinical application ability of medical technology;
(two) does not conform to the planning of the corresponding health administrative department;
(3) Failing to pass the technical audit of the clinical application ability of medical technology;
(four) beyond the scope of registered medical subjects;
(5) Medical technology is incompatible with its functions and tasks;
(six) although it has passed the technical audit of the clinical application ability of medical technology, it no longer has the conditions for clinical application of medical technology;
(seven) other circumstances stipulated by the administrative department of health at or above the provincial level.
Fiftieth medical institutions in any of the following circumstances, the administrative department of health shall immediately order them to correct; Causing serious consequences, the main person in charge of the medical institution and the person directly responsible shall be investigated for responsibility according to law:
(1) Clinical application of medical technology abolished or prohibited by the Ministry of Health;
(two) in violation of the provisions of article fourteenth of these measures, the third new medical technology is put into clinical application without authorization;
(three) the clinical application of medical technology has not been examined by the clinical application ability of medical technology;
(four) failing to report the clinical application of medical technology to the administrative department of health in accordance with the provisions of article fortieth of these measures;
(five) failing to immediately stop the clinical application of medical technology in accordance with the provisions of article forty-first of these measures;
(six) failing to re-apply for the technical evaluation of the clinical application ability of medical technology in accordance with the provisions of Article 44 of these Measures, or applying the medical technology that needs to be re-evaluated to the clinical application ability of medical technology without authorization;
(seven) in violation of other provisions of these measures.
Fifty-first medical institutions allow medical personnel to carry out medical technology beyond their professional ability, which causes damage to patients, and medical institutions shall bear corresponding legal and economic compensation responsibilities; Without the approval of medical institutions, medical personnel apply medical technology without authorization, and medical personnel shall bear corresponding legal and economic compensation responsibilities.
Article 52 Medical institutions and medical practitioners who violate the Medical Practitioners Law, Regulations on the Administration of Medical Institutions, Regulations on the Handling of Medical Accidents, Regulations on Human Organ Transplantation and other laws and regulations in the clinical application of medical technology shall be punished in accordance with relevant laws and regulations.
Fifty-third health administrative departments at or above the provincial level shall strengthen the supervision and management of technical audit institutions. In any of the following circumstances, the administrative department of health of the designated technical audit institution shall cancel its qualification as a technical audit institution:
(a) the medical institutions that have passed the technical audit of the clinical application ability of medical technology do not have the clinical application ability of medical technology;
(two) beyond the technical audit authority or beyond the medical technology directory published by the health administrative department at or above the provincial level, to conduct technical audit on the clinical application ability of medical technology;
(three) to accept the application of the Ministry of Health to abolish or prohibit the use of medical technology for technical review of clinical application ability;
(four) serious violation of technical audit procedures;
(five) can not complete the technical audit work in accordance with the provisions of these measures;
(6) Other circumstances stipulated by the health administrative department at or above the provincial level.
The audit conclusions made by the technical audit institutions in the cases of items (1), (2), (3) and (4) shall not be used by the health administrative department as the basis for examination and approval of medical technology registration under the clinical application and diagnosis and treatment subjects of medical institutions; If the registration has been granted, the health administrative department shall cancel it in time.
Fifty-fourth technical audit institutions shall conduct an annual assessment of the members of the expert database who participate in the technical audit work. If the annual assessment fails or one of the following circumstances is found, the membership of the expert database shall be cancelled, and it shall not be hired to undertake the technical audit work within five years, and the health administrative department of the unit where it belongs and the designated technical audit institution shall be notified in time:
(a) in the technical audit work can not put forward scientific, objective and fair evaluation opinions;
(two) a serious violation of technical audit procedures;
(three) can not complete the technical audit work in accordance with the provisions of these measures;
(four) practicing fraud in the process of technical audit, accepting property or seeking other illegitimate interests;
(5) Other circumstances stipulated by the health administrative department at or above the provincial level.
Article 55 Where any staff member of a technical audit institution abuses his power, practices fraud or illegally accepts property or seeks other illegitimate interests in the process of technical audit, the technical audit institution shall prohibit him from participating in the technical audit, and the unit to which he belongs shall give him administrative sanctions. Technical audit institutions shall not employ them to participate in technical audit within 5 years.
Fifty-sixth health administrative departments and their staff in violation of regulations interfere with the technical audit work, the health administrative department at a higher level or the health administrative department where the staff is located shall promptly correct it; If the consequences are serious, the relevant person in charge and the person directly responsible shall be given administrative sanctions.
Chapter VI Supplementary Provisions
Article 57 For Class III medical technologies that have been clinically applied before the promulgation of these Measures, medical institutions shall, within 6 months after the implementation of these Measures, submit an application for technical evaluation of the clinical application capability of medical technologies to technical evaluation institutions in accordance with the provisions of these Measures. If the application for technical review is not made within 6 months after the implementation of these measures or the health administrative department decides not to register the medical technology under the diagnosis and treatment subjects, the clinical application of the third kind of medical technology will be stopped.
Before the promulgation of these measures, the clinical application ability, technical evaluation and medical technology registration under the subjects of diagnosis and treatment of the first class medical technology and the second class medical technology that have been clinically applied shall be separately stipulated by the provincial health administrative department.
Article 58 Medical technologies such as xenogeneic stem cell therapy, xenogeneic therapy and human somatic cell cloning shall not be applied to clinic for the time being.
Article 59 Measures for the administration of clinical trials of category III medical technologies shall be formulated separately by the Ministry of Health.
Article 60 Where laws and regulations have special provisions on the clinical application of medical technology, such provisions shall prevail.
Article 61 These Measures shall come into force as of May 6, 2009.
attachment
Catalogue of the third kind of medical technology
1. involves major ethical issues, and its safety and effectiveness need to be further verified by standardized clinical trials: cloning therapy, autologous stem cell and immune cell therapy, gene therapy, central nervous system detoxification surgery, stereotactic surgery for psychosis, allogeneic stem cell transplantation, tumor vaccine therapy, etc.
Two, involving major ethical issues, safe and effective medical technology: organ transplantation technology, sex-change surgery, etc.
3. High-risk medical technologies that need to be verified or confirmed for safety and effectiveness: destructive therapy, radioactive particle implantation therapy, tumor hyperthermia, tumor cryotherapy, tissue and cell transplantation, artificial heart implantation, artificial intelligence-assisted diagnosis and treatment, etc.
4. Other medical technologies that need special management: gene chip diagnosis and treatment technology, fracture intensive surgical treatment technology, xenotransplantation technology, etc.