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 conditions 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 professionals engaged in prenatal diagnosis shall meet all the following conditions:
(a) engaged in clinical work, should obtain the qualification of 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:
(a) with obstetrics and gynecology diagnosis and treatment subjects;
(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 Implementation of Article 16: Prenatal screening for ordinary pregnant women, and application of prenatal diagnosis technology to 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.