(December 13, 2002 Ministry of health order 33rd release) Chapter I General provisions article to ensure maternal and child health, improving population quality, guarantee the safety of prenatal diagnostic techniques, effective, regulate the supervision and management of prenatal diagnostic techniques according to the People's Republic of China Law on maternal and child health, as well as the People's Republic of China implementation measures of maternal and infant health care law, enactment of this management approach.
    Second prenatal diagnosis of this management approach that refers to diagnosis on fetal congenital defects and hereditary diseases including screening.
    Projects including genetic counseling, prenatal diagnosis technology of medical imaging, bio-immune, genetic, and molecular genetics.
    Third section of prenatal diagnostic techniques in management measures applicable to all types of healthcare providers.
    Fourth section of prenatal diagnosis technology application for medical purposes, in line with the relevant legal provisions and ethical principles of the State, by permission of the qualification of medical staff in the medical and health care institutions.
    Health care facilities and medical personnel shall not impose any non-medical purpose of prenatal diagnostic techniques.
    Fifth Ministry of health is responsible for the national supervision and administration of prenatal diagnosis technology application.
    Chapter II administrative examination and approval article sixth Ministry of health based on medical needs, technology development, and management needs of your organization, the actual situation, making prenatal diagnosis technology application plan.
    Seventh section of prenatal diagnosis technology application implementation at different levels.
    Ministry of health to develop a prenatal diagnostic technique medical and health institutions of basic conditions and personnel conditions issued technical specifications related to prenatal diagnosis; specify prenatal diagnostic technique medical and health institutions at national level; national quality management and the application of prenatal diagnosis technology information management; to plan for national training in prenatal diagnosis of professional and technical personnel.
    Health administrative departments of provinces, autonomous regions and municipalities (hereinafter referred to as the provincial health Administrative Department) according to local practice, land planning, approving or formation of prenatal diagnostic techniques within the administrative area of the health care institutions; for prenatal diagnosis technology professionals training and qualification systems; quality management and the application of prenatal diagnosis technology and information management.
    The people's Government above the county level health Administrative Department is responsible for the day-to-day supervision and management of prenatal diagnosis technology application in the administrative area.
    Eighth article engaged in prenatal diagnosis of health professional technicians should meet following all conditions: (a) engaged in clinical work of, should made practice industry physician qualification; (ii) engaged in medical technical and auxiliary work of, should made corresponding health professional technology titles; (three) meet engaged in prenatal diagnosis health professional technicians of basic conditions; (four) by provincial health administrative sector approved, made engaged in prenatal diagnosis of maternal and child health technology assessment certificate book.
    Nineth article application carried out prenatal diagnosis technology of medical health institutions should meet following all conditions: (a) has obstetrics and Gynecology Clinic subjects; (ii) has and by carried out technology phase adapted of health professional technicians; (three) has and by carried out technology phase adapted of technology conditions and equipment; (four) has medical ethics Committee; (five) meet carried out prenatal diagnosis technology medical health institutions of basic conditions and the related technology specification.
    Tenth Article application carried out prenatal diagnosis technology of medical health institutions should to location provincial health administrative sector submitted following file: (a) medical institutions practice industry license copy; (ii) carried out prenatal diagnosis technology of maternal and child health technology service practice industry license application file; (three) feasibility report; (four) intends carried out prenatal diagnosis technology of personnel equipped with, and equipment and technology conditions situation; (five) carried out prenatal diagnosis technology of regulations; (six) provincial above health administrative sector provides submitted of other material.
    Prenatal diagnostic technique medical and health care applications for agencies, you must explicitly make prenatal diagnosis of specific projects to be carried out. 11th section of prenatal diagnostic techniques to health care institutions, by the respective Governments of provinces, autonomous regions and municipalities directly under the examined and approved by the health Administrative Department. The provinces, autonomous regions and municipalities directly under the Administrative Department of health under article tenth of the material in these measures, organize experts to demonstrate, and within 30 working days after receiving the expert report for review.
    Approval, to carry out prenatal diagnosis of maternal and child health care service license to practice, annotated for prenatal diagnosis and specific technical services; audited do not agree, inform the applicant in writing.
    12th Ministry of health according to the national development of prenatal diagnosis technology needs, qualified to carry out the examination and approval of prenatal diagnosis technology in health-care institutions, specify national prenatal diagnostic techniques of health care institutions. 13th section of prenatal diagnostic techniques of the maternal and child health care service license to practice check once every three years, checking by the original approval authority.
    After checking compliance may continue to carry out prenatal diagnosis technology; failed to pass the validation, revocation of their licenses.
    14th of provinces, autonomous regions and municipalities designated by the Administrative Department of health under the health-care institutions, assisting the health Administrative Department is responsible for the Organization and management of prenatal diagnosis within the administrative area.
    Article 15th personnel shall not, without permission of the prenatal diagnosis of prenatal diagnostic techniques in medical and health institutions engaged in related work. Chapter III implementation of the 16th article on pregnant women antenatal screening prenatal diagnostic techniques and applications adhere to informed choice.
    Prenatal screening and health care institutions to prenatal diagnostic techniques with the permission of health care institutions to establish working relationships to ensure screening cases implementing subsequent diagnosis.
    17th article pregnant women has following case one of of, by rule physician should recommends its for prenatal diagnosis: (a) amniotic fluid too much or too little of; (ii) fetal development exception or fetal has suspicious deformity of; (three) pregnancy early Shi contact had may led to fetal congenital defects of material of; (four) has genetic disease family history or had delivery had congenital serious defects baby of; (five) age over 35 age of. 18th the previous serious hereditary diseases or serious birth defects in children, before pregnancy, the couple should genetic counseling to health care institutions.
    Medical personnel should be party to introduce relevant knowledge, giving advice and guidance.
    By the attending doctor according to the outcome of the consultation, medical recommendations for parties.
    Article 19th prenatal diagnosis of priority diseases, shall comply with the following conditions: (a) the high incidence of disease, (ii) disease serious disease burden of society, families and individuals, and (iii) lack of effective disease treatment (iv) diagnostic technology is mature, reliable, safe and effective.
    Article 20th antenatal care, midwifery skills of health-care institutions in early pregnancy for pregnant women to check or antenatal care, encountered situations listed in this article 17th pregnant women, should be about the popularization of knowledge, providing advisory services, in writing and inform pregnant women or their families, it is recommended that pregnant women for prenatal diagnosis.
    Article 21st themselves for prenatal diagnosis of pregnant women, providing medical advice by the attending doctor according to the circumstances, by a pregnant woman decides whether to implement the prenatal diagnostic techniques.
    Articles 22nd prenatal diagnostic techniques of prenatal diagnosis report issued by health care organizations, should consist of 2 or more signed by the qualification of practicing physicians.
    Article 23rd prenatal diagnostic techniques and diagnosis, the treating physician should in science, responsible attitude to pregnant women or their families told the safety and effectiveness of technology and risk, pregnant women or their family members understand possible risks and the uncertainty of the results. 24th under the fetal abnormality is found, the treating physician must continue to pregnancy and pregnancy termination may occur, as well as the results of further comments, in writing, clearly inform pregnant women, pregnant couples choose their own treatment program and signed informed consent. If pregnant women lack of cognitive ability, and his close relatives option.
    Ethical issues should be referred to the medical ethics committee discussion.
    25th section of prenatal diagnostic techniques to health care agencies on delivery of the termination of pregnancy following prenatal diagnosis of fetus, with the consent of their families consent, body Anatomy and pathology related to genetic testing.
    26th party who disagrees with the results of prenatal diagnosis, according to the People's Republic of China Law on maternal and child health measures for the implementation of the fifth chapter of the relevant provisions, applying for identification. 27th section of prenatal diagnostic techniques for sex identification of the fetus health care institutions are not allowed to.
    Suspected fetuses could be sex-linked genetic diseases, gender identification is required, by provinces, autonomous regions and municipalities designated by the Administrative Department of health under the health-care institutions in accordance with the relevant provisions of the identification.
    Article 28th of prenatal diagnosis technology medical and health institutions shall set up and perfect the technical archives management and follow-up system.
    Chapter fourth penalty 29th article violates these rules, without prior approval of prenatal diagnosis technology of non-medical health care institutions, in accordance with the relevant provisions of the regulation of medical institutions for punishment. 30th article on violation this approach, medical health institutions not made prenatal diagnosis practice industry license or beyond license range, unauthorized engaged in prenatal diagnosis of, according to People's Republic of China maternal and child health method implementation approach about provides punishment, by health administrative sector give warning, ordered stop violations, confiscated illegal proceeds; illegal proceeds 5000 Yuan above of, and at illegal proceeds 3 times times above 5 times times following of fine; illegal proceeds insufficient 5000 Yuan of, and at 5000 Yuan above 20,000 yuan following of fine.
    In serious cases, according to the medical institution regulations revoked license to practice in medical institutions. 31st without prenatal diagnosis maternal and child health technology appraisal certificate of the individual, without engaging in or beyond the scope of prenatal diagnosis, by Department of the people's Governments above the county level health warning or suspended for more than six months a year practicing in serious cases, in accordance with the People's Republic of China Law on practitioners may revoke a physician practising certificate. Constitute a crime, criminal responsibility shall be investigated according to law.

    Article 32nd disobey article 27th, in accordance with the People's Republic of China implementation measures for the law on maternal and infant health section 42nd of the provisions.
    Fifth chapter supplementary articles article 33rd in all provinces, autonomous regions, municipalities and Health Administration Department in accordance with the measures and local conditions to develop the implementation details.
                                                                                                        34th article of the rules take effect on May 1, 2003.