China Hospital DirectoryThe State Council's Regulations on the Prevention and Handling of Medical Disputes say medical staff should explain the patient's condition and medical measures during diagnosis and treatment.
Written consent in the dispute regulations
The regulations say that where surgery is needed, or clinical trials and other special examinations or special treatment that carry some danger and may produce adverse consequences are to be carried out, medical staff should promptly explain the medical risks and alternative medical plans to the patient and obtain the patient's written consent.
The regulations say that if the patient is in a state, such as a coma, in which the patient cannot make a decision, or the condition is not suitable to be explained to the patient, staff should explain to the patient's close relatives and obtain their written consent.
The regulations say that in an emergency where the opinion of the patient or the close relatives cannot be obtained, immediate medical measures may be carried out with the approval of the head of the medical institution or a person in charge authorised by it.
The regulations say they take effect on 1 October 2018.
Informed consent in the national health law
The Basic Medical and Health Care and Health Promotion Law of the People's Republic of China, which the Standing Committee of the National People's Congress passed on 28 December 2019 (text released by Xinhua), says citizens receiving medical and health services have, in accordance with law, the right to informed consent about their condition, diagnosis and treatment plan, medical risks and medical costs.
The law says it takes effect on 1 June 2020.
The law says citizens receiving medical and health services should be treated with respect, and that medical and health institutions and personnel should care for patients, treat them equally, respect their dignity and protect their privacy.
Consent forms in the inpatient record
The State Council Gazette on the gov.cn site publishes a notice of the National Health and Family Planning Commission and the National Administration of Traditional Chinese Medicine, dated 20 November 2013, that issues the Medical Institution Medical Record Management Provisions (2013 edition).
The provisions say inpatient records are arranged in a set order that includes consent forms for surgery, anesthesia, blood transfusion and special examination (special treatment).
Questions people ask
When do the dispute regulations say written consent is obtained?
The regulations say that where surgery is needed, or clinical trials and other special examinations or special treatment that carry some danger and may produce adverse consequences are to be carried out, medical staff should promptly explain the medical risks and alternative medical plans to the patient and obtain the patient's written consent.
Who do the regulations say gives consent when the patient cannot decide?
The regulations say that if the patient is in a state, such as a coma, in which the patient cannot make a decision, or the condition is not suitable to be explained to the patient, staff should explain to the patient's close relatives and obtain their written consent.
What does the national health law say about informed consent?
The Basic Medical and Health Care and Health Promotion Law of the People's Republic of China, which the Standing Committee of the National People's Congress passed on 28 December 2019 (text released by Xinhua), says citizens receiving medical and health services have, in accordance with law, the right to informed consent about their condition, diagnosis and treatment plan, medical risks and medical costs.
Sources
- Regulations on the Prevention and Handling of Medical Disputes (State Council, gov.cn), read 26 October 2026
- Basic Medical and Health Care and Health Promotion Law (Xinhua authorised release), read 26 October 2026
- Medical Institution Medical Record Management Provisions, 2013 edition (State Council Gazette, gov.cn), read 26 October 2026
Each source above was read on the date shown. This page is an unofficial summary of general administrative information. It is not published by the bodies named above, and it is not medical or legal advice. If it differs from the official pages, the official pages prevail, and rules may change after the check date.
Entry facts come from the hospital’s own pages as read on the dates shown in each source note; this unofficial summary is not medical advice, and the hospital’s current published information prevails. Medical and legal notice