Article 1 In order to protect maternal and infant health, improve the quality of the birth population, ensure the safety and effectiveness of prenatal diagnosis technology, and standardize the supervision and management of prenatal diagnosis technology, these administrative measures are formulated in accordance with the Law of the People's Republic of China on Maternal and Infant Health Care and the Implementation Measures of the Law of the People's Republic of China on Maternal and Infant Health Care. Article 2 The term "prenatal diagnosis" as mentioned in these Administrative Measures refers to the diagnosis of fetal congenital defects and hereditary diseases, including corresponding screening. Prenatal diagnosis technology projects include genetic counseling, medical imaging, biochemical immunity, cytogenetics and molecular genetics. Article 3 These administrative measures are applicable to all kinds of medical and health institutions that carry out prenatal diagnosis technology. Article 4 The application of prenatal diagnosis technology should aim at medical treatment, conform to relevant national laws and ethical principles, and be implemented by qualified medical personnel in licensed medical and health institutions. Medical and health institutions and medical personnel shall not implement any prenatal diagnosis technology for non-medical purposes. Article 5 The Ministry of Health shall be responsible for the supervision and management of the application of prenatal diagnostic techniques throughout the country. Chapter II Management and Approval
Article 6 The Ministry of Health shall formulate the application plan of prenatal diagnosis technology according to the actual situation such as medical needs, technological development and organizational management needs. Article 7 The application of prenatal diagnosis technology shall be managed at different levels. The Ministry of Health has formulated the basic conditions and personnel conditions for medical and health institutions to carry out prenatal diagnosis technology; Promulgating technical specifications for prenatal diagnosis; Designate national medical and health institutions to carry out prenatal diagnosis technology; Quality management and information management of prenatal diagnosis technology application in China: planning the training of prenatal diagnosis professionals in China. The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as the provincial health administrative departments) shall, according to local conditions, plan, approve or establish medical and health institutions that carry out prenatal diagnosis technology within their respective administrative areas; Systematic training and qualification certification for professionals engaged in prenatal diagnosis technology; Quality management and information management of prenatal diagnosis technology application. The health administrative department of the people's government at or above the county level shall be responsible for the daily supervision and management of the application of prenatal diagnosis technology within its administrative area. Article 8 Health technicians engaged in prenatal diagnosis shall meet the following conditions: (1) Those engaged in clinical work shall be qualified as medical practitioners; (two) engaged in medical technology and auxiliary work, should obtain the corresponding professional and technical titles of health; (three) in line with the "basic conditions for professional and technical personnel engaged in prenatal diagnosis and health"; (four) approved by the provincial health administrative department, and obtained the "maternal and child health care technology inspection certificate", before prenatal diagnosis. Article 9 A medical and health institution applying for prenatal diagnosis technology shall meet the following conditions: (1) It has the subjects of obstetrics and gynecology diagnosis and treatment; (2) Having health professionals suitable for the developed technology; (3) Having the technical conditions and equipment suitable for the development technology; (4) Having a medical ethics committee; (five) in line with the "basic conditions for medical and health institutions to carry out prenatal diagnosis technology" and related technical specifications. Tenth medical and health institutions applying for prenatal diagnosis technology shall submit the following documents to the local provincial health administrative department:
(1) A copy of the practice license of the medical institution; (two) the application documents for the practice license of maternal and infant health care technical services to carry out prenatal diagnosis technology; (3) Feasibility report; (four) the staffing, equipment and technical conditions of prenatal diagnosis technology; (five) the rules and regulations for the development of prenatal diagnosis technology; (six) other materials required by the administrative department of health at or above the provincial level. Medical and health institutions applying for prenatal diagnosis technology must clearly put forward specific technical projects to be carried out. Article 11 Medical and health institutions applying for prenatal diagnosis technology shall be examined and approved by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, after receiving the materials specified in Article 10 of these Measures, organize relevant experts to conduct argumentation and conduct audit within 30 working days after receiving the expert argumentation report. After examination and approval, it will be issued with the Practice License for Maternal and Infant Health Care Technical Services to carry out prenatal diagnosis technology, indicating the prenatal diagnosis and specific technical services; If the applicant disagrees after examination, it shall notify the applicant in writing. Article 12 The Ministry of Health shall, according to the needs of the development of prenatal diagnosis technology throughout the country, designate national medical and health institutions to carry out prenatal diagnosis technology among the medical and health institutions that have passed the examination and approval. Thirteenth to carry out prenatal diagnosis technology "maternal and infant health care technical service practice license" once every three years, the calibration shall be handled by the original examination and approval authority. After verification, you can continue to carry out prenatal diagnosis technology; If the audit is unqualified, its license shall be revoked. Article 14 Medical and health institutions designated by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall assist the health administrative departments in organizing and managing prenatal diagnosis within their respective administrative areas. Fifteenth personnel engaged in prenatal diagnosis shall not engage in related work in medical and health institutions that carry out prenatal diagnosis technology without permission. Chapter III Practical Application
Sixteenth pregnant women to implement prenatal screening and prenatal diagnosis technology should adhere to informed choice. Medical and health institutions that carry out prenatal screening should establish working contacts with medical and health institutions that have obtained the license to carry out prenatal diagnosis technology to ensure that the screened cases can be followed up for diagnosis. Article 17 If a pregnant woman has any of the following circumstances, the attending physician shall advise her to make a prenatal diagnosis: (1) Too much or too little amniotic fluid; (2) The fetus has abnormal development or the fetus has suspicious malformation; (3) Having been exposed to substances that may cause birth defects in the first trimester; (4) Having a family history of hereditary diseases or having a baby with serious birth defects; (five) at least 35 years of age. Eighteenth in the past have given birth to serious genetic diseases or serious defects of children, before the second pregnancy, both husband and wife should go to medical and health institutions for genetic counseling. Medical personnel should introduce relevant knowledge to the parties and give suggestions and guidance. According to the consultation results, the attending doctor puts forward medical suggestions to the parties. Article 19 To determine the key diseases for prenatal diagnosis, the following conditions shall be met: (1) The incidence of diseases is relatively high; (two) serious disease harm, social, family and personal disease burden; (3) Lack of effective clinical treatment; (four) the diagnosis technology is mature, reliable, safe and effective. Article 20 Medical and health institutions that carry out prenatal examination and midwifery technology should popularize relevant knowledge, provide consulting services, and truthfully inform pregnant women or their families in writing when conducting early pregnancy examination or prenatal examination, and suggest pregnant women to make prenatal diagnosis. Twenty-first pregnant women for prenatal diagnosis, the attending physician can provide medical advice according to their situation, and the pregnant woman decides whether to implement prenatal diagnosis technology. Twenty-second prenatal diagnosis report issued by medical and health institutions to carry out prenatal diagnosis technology should be issued by two or more qualified doctors. Article 23 For prenatal diagnosis technology and diagnosis results, the attending physician shall inform pregnant women or their families of the safety, effectiveness and risks of the technology in a scientific and responsible manner, so that pregnant women or their families can understand the possible risks and uncertainty of the results of the technology. Article 24 If the fetus is abnormal, the attending physician must clearly inform the pregnant woman in writing of the possible results of continuing pregnancy and terminating pregnancy and the opinions on further treatment, and the pregnant woman and her husband and wife shall choose their own treatment plan and sign an informed consent form. If pregnant women lack cognitive ability, their close relatives will choose for them. Involving ethical issues, it shall be submitted to the Medical Ethics Committee for discussion. Twenty-fifth medical and health institutions that carry out prenatal diagnosis technology shall, after obtaining the consent of their families, carry out autopsy and related genetic examination on the fetus that terminates pregnancy and delivery after prenatal diagnosis. Twenty-sixth parties who have objections to the prenatal diagnosis results may apply for technical appraisal according to the relevant provisions of Chapter V of the Implementation Measures of the Maternal and Infant Health Care Law of the People's Republic of China. Twenty-seventh medical and health institutions that carry out prenatal diagnosis technology shall not conduct fetal sex identification without authorization. If it is suspected that the fetus may be a sex-linked genetic disease and needs sex identification, the medical and health institutions designated by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall conduct identification in accordance with relevant regulations. Twenty-eighth medical and health institutions to carry out prenatal diagnosis technology should establish and improve the technical file management and follow-up observation system. Chapter IV Punishment
Twenty-ninth non medical and health institutions that violate the provisions of these measures and carry out prenatal diagnosis technology without approval shall be punished in accordance with the relevant provisions of the Regulations on the Administration of Medical Institutions. Article 30 If a medical and health institution violates these measures, fails to obtain the Practice License for Prenatal Diagnosis or engages in prenatal diagnosis beyond the permitted scope, it shall be punished in accordance with the relevant provisions of the Measures for the Implementation of the Law of the People's Republic of China on Maternal and Infant Health Care, and the administrative department of health shall give it a warning, order it to stop the illegal act and confiscate the illegal income; Illegal income of more than 5000 yuan, and impose a fine of more than 3 times and less than 5 times the illegal income; If the illegal income is less than 5,000 yuan, a fine ranging from 5,000 yuan to 20,000 yuan shall be imposed. If the circumstances are serious, the practice license of medical institutions shall be revoked according to the Regulations on the Administration of Medical Institutions. Thirty-first did not obtain the "prenatal diagnosis of maternal and infant health care technology assessment certificate" to engage in prenatal diagnosis or beyond the scope of permission, by the health administrative department of the people's government at or above the county level shall give a warning or be ordered to suspend practice for more than six months and less than one year; If the circumstances are serious, the doctor's practice certificate shall be revoked in accordance with the Law of People's Republic of China (PRC) Municipality on Medical Practitioners. If a crime is constituted, criminal responsibility shall be investigated according to law. Thirty-second in violation of the provisions of article twenty-seventh, shall be punished in accordance with the provisions of article forty-second of the measures for the implementation of the law of the people's Republic of China on maternal and infant health care. Chapter V Supplementary Provisions
Article 33 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government may formulate detailed rules for implementation according to these Measures and local actual conditions. Article 34 These Measures shall come into force as of May 6, 2003.