Measures for the Management of Human Assisted Reproductive Technology

Chapter I General Provisions Article 1 In order to ensure the safe, effective and healthy development of human assisted reproductive technology, standardize the application and management of human assisted reproductive technology, and safeguard the people's health, these measures are formulated. Article 2 These measures apply to all types of medical institutions to carry out human assisted reproductive technology. Article 3 The application of human assisted reproductive technology shall be carried out in medical institutions for medical purposes and in accordance with national family planning policies, ethical principles and relevant laws. The sale and purchase of gametes, congeners and embryos in any form is prohibited. Medical institutions and medical personnel shall not implement any form of surrogacy technology. Article 4 The Ministry of Health shall be in charge of the supervision and management of the application of human assisted reproduction technology throughout the country. The health administrative departments of the local people's governments at or above the county level are responsible for the daily supervision and management of human assisted reproduction technology in their administrative areas. Article 5 The Ministry of Health shall formulate plans for the application of human assisted reproductive technology in accordance with regional health planning, medical needs and technical conditions. Article 6 Medical institutions applying to carry out human assisted reproduction technology shall meet the following conditions:

(1) have health professionals and technicians and other professional and technical personnel appropriate to carry out the technology;

(2) have technology and equipment appropriate to carry out the technology;

(3) have a medical ethics committee;

(4) conform to the "Specification for Human Assisted Reproductive Technology" formulated by the Ministry of Health. (d) Meet the requirements of the Code of Assisted Human Reproductive Technology formulated by the Ministry of Health. Article 7 A medical institution applying to carry out human assisted reproduction technology shall submit the following documents to the health administrative department of the people's government of the province, autonomous region or municipality directly under the central government where it is located:

(1) feasibility report;

(2) the basic situation of the medical institution (including the number of beds, the setting up of departments and divisions, the personnel, the equipment and the technical conditions);

(3) the business items of the proposed human assisted reproduction technology;

(4) the requirements set by the Ministry of Health for human assisted reproduction technology. (C) the business items and technical conditions of the assisted human reproduction technology to be carried out, equipment conditions, and technical personnel;

(D) the rules and regulations for carrying out the assisted human reproduction technology;

(E) other materials required to be submitted by the administrative departments of health at or above the provincial level. Article 8 Medical institutions applying to carry out artificial insemination technology with husband's semen 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. Provinces, autonomous regions, municipalities directly under the Central People's Government of the health administrative department receives the materials provided for in the preceding Article, may organize relevant experts to carry out demonstration, and within 30 working days after receiving the expert demonstration report for examination, examination agreed, issued a certificate of approval; examination does not agree, notify the applicant unit in writing.

The application to carry out artificial insemination and in vitro fertilization-embryo transfer technology and its derivative technology of medical institutions, by the provinces, autonomous regions and municipalities directly under the Central People's Government of the health administrative department to put forward the preliminary examination of the views of the Ministry of Health for approval. Article 9 The Ministry of Health shall, upon receiving the preliminary opinions and materials from the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government, hire relevant experts to conduct demonstrations and conduct audits within 45 working days after receiving the expert's demonstration report, and issue certificates of approval if the audit agrees with the approval; and if the audit does not agree with the approval, the applicant shall be notified of such approval in writing. Article 10 The medical institutions approved to carry out human assisted reproductive technology shall, in accordance with the relevant provisions of the "Regulations on the Administration of Medical Institutions", hold the certificate of approval of the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government or the Ministry of Health to the administrative department of health that issued the license to practice in its medical institutions for the purpose of changing the registration procedures. Article 11 The certificate of approval for human assisted reproduction technology shall be verified once every two years, and the verification shall be handled by the original approval authority. If the verification is qualified, it can continue to carry out human assisted reproduction technology; if the verification fails, the certificate of approval shall be withdrawn. Chapter III implementation of Article 12 of the human assisted reproductive technology must be implemented in approved and registered medical institutions. Without the approval of the administrative department of health, no unit or individual may implement human-assisted reproductive technology. Article 13 The implementation of human assisted reproductive technology shall be in accordance with the provisions of the Code of Human Assisted Reproductive Technology formulated by the Ministry of Health. Article 14 The implementation of human assisted reproductive technology shall follow the principle of informed consent, and sign an informed consent form. Where ethical issues are involved, they shall be submitted to the Medical Ethics Committee for discussion. Article 15 Medical institutions implementing donor sperm artificial insemination and in vitro fertilization-embryo transfer techniques and their various derivative techniques shall sign sperm supply agreements with human sperm banks approved by the Ministry of Health. Private sperm collection is strictly prohibited.

Medical institutions in the implementation of assisted human reproduction technology shall request a sperm test certificate. Article XVI of the implementation of assisted human reproductive technology medical institutions should be confidential for the parties concerned, shall not disclose the relevant information. Article XVII of the implementation of human assisted reproductive technology in medical institutions shall not be sex selection. Except as otherwise provided by laws and regulations. Article 18 The implementation of human assisted reproductive technology medical institutions shall establish and improve the technical file management system.

Sperm artificial insemination medical behavior of medical technology files and legal documents shall be permanently preserved. Article 19 of the implementation of assisted human reproduction technology medical institutions shall implement assisted human reproduction technology personnel for medical business and ethical knowledge training. Article 20 The Ministry of Health designated health technology assessment organization to carry out human assisted reproduction technology of medical institutions for technical quality monitoring and regular assessment. The main contents of the technical assessment are the safety, effectiveness, economy and social impact of human assisted reproductive technology. Monitoring results and technical assessment report on the location of medical institutions in the provincial, autonomous regions and municipalities directly under the Central People's Government health administrative departments and the Ministry of Health for the record.