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The National Blood Transfusion Law of the People’s Republic of China (hereinafter referred to as the “Law”) is formulated in accordance with the Constitution of the People’s Republic of China and relevant laws and regulations, in order to promote the progress of blood transfusion service, protect the safety of blood products, safeguard the health and safety of the masses, and regulate the activities of blood transfusion organizations, blood product manufacturers and blood donors.
Article 1 (Purpose)
This Law is intended to ensure the safe and effective use of donated blood and blood products, and to protect the rights and interests of blood donors and blood transfusion organizations.
Article 2 (Definition)
【代码5b02】For the purposes of this Law, the following terms shall be defined as follows:
(1) Blood transfusion organizations refer to organizations that provide blood collection, processing and supply services.
(2) Blood product manufacturers refer to organizations that produce and supply blood products for use in transfusion.
(3) Blood donors refer to individuals who voluntarily donate their blood for use in transfusion.
Article 3 (Basic Principles)
The activities of blood transfusion organizations, blood product manufacturers and blood donors shall comply with the principles of voluntariness, safety, respect for human dignity and the rights of the parties concerned.
Article 4 (Blood Donors)
(1) Blood donors shall meet the requirements of the State for blood donation.
(2) Blood donors shall have a clear understanding of the purpose, method and risks of blood donation, and shall sign a written consent form in a voluntary and informed manner.
(3) Blood donors shall undergo necessary physical examinations prior to donation and shall not donate blood if they are found to be unsuitable for donation.
Article 5 (Blood Transfusion Organizations)
(1) Blood transfusion organizations shall comply with relevant laws and regulations and shall implement a quality control system for the collection, processing, storage and supply of blood and blood products.
(2) Blood transfusion organizations shall regularly carry out physical examinations and tests in accordance with the national standards for blood donors in order to ensure the safety of blood donations.
(3) Blood transfusion organizations shall implement a comprehensive information management system that records information collected from blood donors and blood recipients, and shall maintain such records in accordance with relevant laws and regulations.
Article 6 (Blood Product Manufacturers)
(1) Blood product manufacturers shall comply with relevant laws and regulations and shall implement a quality control system for the production and supply of blood products.
(2) Blood product manufacturers shall regularly conduct physical examinations and tests in accordance with the national standards for blood donors in order to ensure the safety of blood products.
Article 7 (Supervision and Administration)
The State shall establish a system of supervision and administration of blood transfusion activities and shall be responsible for the supervision and administration of blood transfusion organizations, blood product manufacturers and blood donors.
Article 8 (Legal Liability)
Any person who violates this Law shall be subject to legal liability in accordance with the law.
The National Blood Transfusion Law of the People’s Republic of China is hereby promulgated, and shall enter into force on the date of its promulgation.

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