Human sperm banks must be located in medical institutions. Article 3 The collection and provision of spermatozoa shall abide by the principles of voluntariness of the person concerned and conformity with social ethics.
No organization or individual may conduct sperm collection and provision activities for profit. Article 4 The Ministry of Health shall be in charge of the supervision and management of human sperm banks nationwide. The health administrative departments of the local people's governments at or above the county level shall be responsible for the daily supervision and management of human sperm banks within their administrative areas. Chapter II Approval Article 5 The Ministry of Health shall formulate plans for the establishment of human sperm banks in accordance with China's health resources, demand for sperm supply, sources of sperm, technical conditions and other actual circumstances. Article 6 The establishment of a human sperm bank shall be approved by the Ministry of Health. Article 7 A medical institution applying for the establishment of a human sperm bank shall meet the following conditions:
(1) it shall have a license to practice as a medical institution;
(2) it shall have a medical ethics committee;
(3) it shall have health professionals and technicians suitable for collecting, testing, preserving and providing sperm;
(4) it shall have technology suitable for collecting, testing, preserving and providing sperm. providing sperm;
(e) having technical ability to screen sperm donors;
(f) shall comply with the Basic Standards for Human Sperm Banks formulated by the Ministry of Health. Article 8 A medical institution applying for the establishment of a human sperm bank shall submit the following information 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) a feasibility report on the establishment of a human sperm bank;
(2) the basic information of the medical institution;
(3) the architectural design plan of the human sperm bank to be set up;
(4) the proposed (d) the technical scope of business to be carried out by the proposed human sperm bank, the conditions of the technical equipment, the technical personnel and the organizational structure;
(e) the rules and regulations of the human sperm bank, the technical operation manual, etc.;
(f) other materials stipulated by the administrative departments of health at the provincial level or above. Article 9 Upon receipt of the materials stipulated in the preceding Article, the health administrative department of the people's government of the province, autonomous region or municipality directly under the central government shall put forward its preliminary opinions and report them to the Ministry of Health for approval. Article 10 After receiving the preliminary opinions and materials from the health administrative departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government, the Ministry of Health shall employ relevant experts to conduct the demonstration and shall conduct the examination and approval within 45 working days after receiving the expert's report of the demonstration and shall issue a certificate of approval of the human sperm bank if the examination and approval are agreed upon; if the examination and approval are disagreed upon, the applicant shall be notified of such agreement in writing. Article 11 The medical institution approved to set up a human sperm bank shall, in accordance with the relevant provisions of the "Regulations on the Administration of Medical Institutions", hold the certificate of approval of the Ministry of Health to the administrative department of health which issues the license for practicing in its medical institution to handle the change of registration formalities. Article 12 The certificate of approval of a human sperm bank shall be verified once every two years, and if it passes the verification, the work of the human sperm bank may be continued; if it fails the verification, the certificate of approval of the human sperm bank shall be withdrawn. Chapter III Sperm Collection and Provision Article 13 Sperm collection and provision shall be carried out in an approved human sperm bank. No entity or individual may engage in sperm collection and provision without authorization. Article 14 Sperm collection and provision shall strictly comply with the Technical Code for Human Sperm Banks and the technical operation procedures formulated by the Ministry of Health. Article 15 Sperm donors shall be healthy males between the ages of 22 and 45. Article 16 The human sperm bank shall carry out health examination and strict screening of the sperm donor, and shall not collect semen from any person with one of the following conditions:
(1) having a family history of hereditary disease or suffering from hereditary disease;
(2) mentally ill persons;
(3) persons suffering from infectious disease or carriers of the disease source;
(4) persons who have been in contact with radiation and harmful substances for a long period of time;
(5) persons who have been in contact with the human sperm bank for a long period of time; and harmful substances;
(v) those whose semen examination fails;
(vi) those with other serious organic diseases. Article 17 The staff of the human sperm bank shall explain to the sperm donor the use of the sperm, the way of preservation as well as the social and ethical issues that may be brought about. The human sperm bank shall sign an informed consent form with the sperm donor. Article 18 A sperm donor can only provide sperm in one human sperm bank. Article 19 After collecting sperm, the sperm bank shall conduct tests and screening. Only after the sperms have been frozen for six months and have been re-examined and passed can they be provided to medical institutions approved by the administrative department of health to carry out assisted human reproduction technology, and the test results shall be submitted to the medical institutions. Without test or failed test, shall not be provided to the medical institutions.
Sperm banks are strictly prohibited from providing fresh sperm to medical institutions.
Sperm banks are strictly prohibited from providing sperm to medical institutions that are not authorized to carry out assisted human reproduction technology. Article 20 The sperm of a sperm donor can only be provided to a maximum of five women for fertilization. Article 21 The human sperm bank shall establish a file on the sperm donor, computerize the details of the sperm donor and the use of sperm and keep it permanently.
The human sperm bank shall keep the confidentiality of the sperm donor and the sperm recipient, and shall not disclose the relevant information without the consent of the sperm donor and the sperm recipient.