The "Regulations on the Administration of Medical Institutions" welcomes another major adjustment!

Following the heavy revision in 2016, the "Regulations on the Administration of Medical Institutions" promulgated by the State Council in 1994 ushered in another major adjustment, which will be implemented from May 1, 2022
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The specific revisions are as follows: Amend Article 9 of the Regulations on the Administration of Medical Institutions to read: “Where a unit or individual establishes a medical institution, and in accordance with the provisions of the State Council, it shall apply for the approval letter for setting up a medical institution, and shall be subject to examination by the health administrative department of the local people’s government at or above the county level.
Approval, and obtain the approval letter for setting up a medical institution
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" Delete Article 14
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Change Article 15 to Article 14 and amend it to read: “A medical institution must register and obtain a “Medical Institution Practicing License”; After filing, you can practice
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” Article 16 is changed to Article 15, and item 1 is amended to read “(1) Where an approval letter for the establishment of a medical institution is required in accordance with regulations, the approval letter for the establishment of a medical institution has been obtained
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” Article 17 is changed to Article 16, and Paragraph 1 is amended to read “The practice registration of a medical institution shall be handled by the health administrative department of the people’s government that approves its establishment; Registration shall be handled by the health administrative department of the local people's government at or above the county level
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" Paragraph 3 is amended to read "Practice registration of outpatient departments, health clinics (rooms) and clinics set up by organs, enterprises and institutions to serve internal employees.
Or the recordation shall be handled by the health administrative department of the people's government at the county level where it is located
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" Change Article 20 to Article 19 and amend it to "A medical institution that changes its name, location, main person in charge, medical subjects, and beds must register with the original one.
The department shall handle the modification registration or file with the original recordation agency
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” Article 21 is changed to Article 20, and Paragraph 1 is amended to read “When a medical institution goes out of business, it must go through the cancellation registration with the original registration agency or file with the original recordation agency
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After registration After the approval of the authority, the "Medical Institution Practicing License" shall be collected
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"Article 24 is changed to Article 23 and amended to read "Any unit or individual shall not carry out diagnosis and treatment activities without obtaining the "Practice License of Medical Institution" or without filing
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Change Article 27 to Article 26, and amend it to read "Medical institutions must carry out diagnosis and treatment activities in accordance with the approved registration or recordation of diagnosis and treatment subjects
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"Article 33 is changed to Article 32 and amended to read "Medical personnel shall explain the condition and medical measures to patients during diagnosis and treatment activities
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If an operation, special examination, or special treatment is required, the medical staff shall explain the medical risks, alternative medical plans, etc.
to the patient in a timely manner, and obtain their explicit consent; and obtain its express consent
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If the opinions of the patients or their close relatives cannot be obtained due to emergency situations such as rescuing a dying patient, the corresponding medical measures may be implemented immediately with the approval of the person in charge of the medical institution or the authorized person in charge
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"Article 40 is changed to Article 39, and the first item is amended to read "(1) Responsible for the establishment, approval, practice registration, filing and verification of medical institutions"
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Article 44 is changed to fourth Article 13 is amended to read: "Those who violate the provisions of Article 23 of these Regulations and practice without obtaining the "Practice License for Medical Institutions" shall be punished in accordance with the "Basic Medical Care and Health Promotion Law of the People's Republic of China"
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"If a clinic violates the provisions of Article 23 of these regulations and practices without a record, the health administrative department of the people's government at or above the county level shall order it to make corrections, confiscate the illegal gains, and impose a fine of not more than 30,000 yuan; if it refuses to make corrections, it shall be ordered to make corrections.
Suspension of practicing activities
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" Change Article 45 to Article 44, and amend it to read "Anyone who violates the provisions of Article 21 of these Regulations and still engages in diagnosis and treatment activities without verifying the "Practice License for Medical Institutions" within the time limit shall be The health administrative department of the people's government at or above the county level shall order it to complete the verification procedures within a time limit; if the verification is refused, its "Medical Institution Practicing License" shall be revoked.

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"Article 46 is changed to Article 45 and amended to read "Anyone who violates the provisions of Article 22 of these Regulations and sells, transfers or lends the "Practice License for Medical Institutions" shall be subject to the "Basic Medical and Health Care of the People's Republic of China".
and the provisions of the Health Promotion Act
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"Article 47 is changed to Article 46 and amended to read "Anyone who violates the provisions of Article 26 of these Regulations and whose diagnosis and treatment activities exceed the scope of registration or filing shall be warned or ordered by the health administrative department of the people's government at or above the county level.
If they make corrections, their illegal gains will be confiscated, and a fine of not less than 10,000 yuan but not more than 100,000 yuan may be imposed according to the circumstances; if the circumstances are serious, their "Medical Institution Practicing License" will be revoked or ordered to stop practicing activities
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"Article 48 is changed to Article 47 and amended to read "Anyone who violates the provisions of Article 27 of these Regulations and employs non-hygienic technical personnel to engage in medical and health technical work shall be ordered by the health administrative department of the people's government at or above the county level.
If he makes corrections within a time limit, he may be fined not less than 10,000 yuan but not more than 100,000 yuan; if the circumstances are serious, his "Medical Institution Practicing License" will be revoked or he will be ordered to stop practicing
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"Article 49 is changed to Article 48, and amended to read "Anyone who violates Article 31 of these Regulations and issues false certification documents shall be warned by the health administrative department of the people's government at or above the county level; A fine of not less than 10,000 yuan but not more than 100,000 yuan may be imposed; the directly responsible persons shall be given administrative sanctions by the unit to which they belong or by the higher-level organ
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" Article 54 is deleted
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