Chapter I General Principles

Article 1 In order to strengthen and standardize the issuance and management of radiation diagnosis and treatment licenses, these measures are formulated in accordance with the provisions of the Law of People's Republic of China (PRC) on the Prevention and Control of Occupational Diseases, the Regulations on the Safety and Protection of Radioisotopes and Radiation Devices, and the Regulations on the Management of Radiation Diagnosis and Treatment, combined with the actual situation in our province.

Article 2 These Measures shall apply to medical and health institutions that carry out radiation diagnosis and treatment in this province.

Article 3 Medical and health institutions engaged in radiation diagnosis and treatment must obtain a radiation diagnosis and treatment license issued by the administrative department of health (hereinafter referred to as the license) before they can engage in radiation diagnosis and treatment activities within the permitted scope.

Article 4 Radiological diagnosis and treatment refers to the activities of clinical medical diagnosis, treatment and health examination by using radioisotopes and ray devices. It is divided into four categories: radiotherapy, nuclear medicine, interventional radiology and X-ray image diagnosis.

Chapter II Licensing of Radiological Diagnosis and Treatment

Article 5 A medical and health institution shall have the professional qualification suitable for its radiation diagnosis and treatment activities.

Sixth medical and health institutions to set up radiation diagnosis and treatment projects, should be based on the types of their diagnosis and treatment activities, in accordance with the provisions of these measures to the corresponding health administrative departments to apply.

Seventh provincial health administrative departments are responsible for the acceptance, examination, approval and licensing of medical and health institutions that carry out radiotherapy and nuclear medicine activities. The provincial health administrative department entrusts the municipal health administrative department with districts (hereinafter referred to as the municipal health administrative department) to undertake the acceptance, data review and on-site audit of the radiation diagnosis and treatment license of medical and health institutions carrying out nuclear medicine activities.

Article 8 The municipal public health administrative department shall be responsible for the acceptance, examination, approval and licensing of medical and health institutions involved in radiation activities within its jurisdiction.

Ninth health administrative departments at the county level shall be responsible for the acceptance, examination, approval and licensing of medical and health institutions that carry out X-ray image diagnosis activities within their respective jurisdictions.

Tenth medical and health institutions that carry out different types of radiation diagnosis and treatment activities at the same time shall apply to the health administrative department with the highest category of examination and approval authority for the "radiation diagnosis and treatment license".

Eleventh medical and health institutions that carry out radiation diagnosis and treatment activities shall apply to the corresponding health administrative department for the establishment of radiation diagnosis and treatment projects, and submit the following materials:

(1) Application Form for Radiological Diagnosis and Treatment Permit (Annex1);

(2) Practice License of Medical Institution or Approval Letter for Establishment of Medical Institution (copy);

(three) the list of radiation diagnosis and treatment personnel (Annex 2) and the qualification certificate of radiation diagnosis and treatment professional and technical personnel or related professional training (training) certificate (copy);

(4) List of radiation diagnosis and treatment equipment, radiation protection and quality control equipment (Annex 3);

(five) the radiation protection test report issued by the institution recognized by the administrative department of health;

(six) the completion of the construction project health acceptance certificate;

(seven) radiation protection rules and regulations and emergency plans for radiation accidents;

(eight) other relevant information required by the administrative department of health according to law.

Article 12 Where the application materials are complete and meet the requirements, the health administrative department shall accept them in time and issue a notice of acceptance of the license application to the applicant within 5 working days; If it does not meet the requirements, it shall inform the applicant of all the contents that need to be corrected at one time or issue a notice of rejection of the license application, and inform the applicant of the reasons for rejection.

Article 13 The administrative department of health shall make a decision on whether to approve the administrative license within 20 working days from the date of formal acceptance. Upon examination, if it meets the requirements, it shall make a written decision to grant the administrative license. If it does not meet the requirements after examination, it shall make a written decision not to grant administrative license, explain the reasons at the same time, and inform the corresponding relief rights.

Article 14 The municipal health administrative department shall complete the written examination and on-site examination of the application materials within 12 working days from the date of formal acceptance, and submit the application materials to the provincial health administrative department after examination and seal.

Fifteenth medical and health institutions shall, after obtaining the license, go through the registration formalities for the corresponding diagnosis and treatment subjects at the health administrative department that issued the Practice License for Medical Institutions. Radiological diagnosis and treatment activities shall not be carried out without permission or registration of diagnosis and treatment subjects.

Article 16 The license shall be issued at the same time as the Practice License of Medical Institution. Medical and health institutions shall, 30 days before the prescribed calibration period, apply to the health administrative department that originally issued the certificate and submit the following relevant materials:

(1) The original and photocopy of the license;

(two) the radiation protection test report issued by the institution recognized by the administrative department of health during this calibration period;

(three) the certification materials of professional and protective knowledge training, health examination and personal dose detection of radiation diagnosis and treatment personnel;

(four) the report of the radiation work carried out by the unit in this calibration period;

(five) other information required by the administrative department of health according to law.

If it meets the relevant provisions after examination, the health administrative department shall verify it.

Seventeenth medical and health institutions to change the project of radiation diagnosis and treatment, it shall apply to the original radiation diagnosis and treatment license examination and approval authority for permission to change, and submit the following materials:

(a) medical and health institutions to change the license for radiation diagnosis and treatment;

(two) the original license (original and copy);

(three) a copy of the qualification certificate of the professional and technical personnel corresponding to the change project;

(four) to change the equipment, radiation protection and quality control equipment list of radiation diagnosis and treatment subjects;

(five) the completion certificate of the new radiation diagnosis and treatment construction project;

(six) other information required by the administrative department of health according to law.

At the same time, apply to the administrative department of health for registration of change of medical subjects. The administrative department of health shall make a review decision within 20 working days from the date of accepting the application for change, and it shall not be changed without approval.

Eighteenth health administrative departments at or above the county level must strictly follow the authority, scope, conditions and procedures stipulated by laws, regulations and rules, and follow the principles of openness, fairness, justice and convenience, and do a good job in the management of license issuance. Health administrative departments at all levels shall establish a license information management system, and regularly publish the list of radiation treatment units that have obtained, revoked or cancelled their licenses.

Nineteenth health administrative departments at or above the county level shall supervise and inspect the medical and health institutions engaged in radiation diagnosis and treatment activities within their respective jurisdictions according to law.

Article 20 If the license is lost, the original holder shall apply to the originally approved health administrative organ for a replacement within 60 days after the loss. The license verification period remains unchanged.

Chapter III Health Examination of Radiological Diagnosis and Treatment Construction Projects

Twenty-first new construction, renovation and expansion of radiotherapy construction projects (hereinafter referred to as construction projects) radiation protection facilities must be designed, constructed and put into operation at the same time as the main project.

Twenty-second before the start of construction projects, medical and health institutions shall, in accordance with the provisions of these measures, apply to the corresponding health administrative departments for health examination and submit the following materials:

(a) the application for health examination of construction projects;

(2) Pre-evaluation report on radiation protection against occupational hazards of construction projects issued by the institutions recognized by the health administrative department;

(three) the environmental plan of the construction project (including the name, height, river and road of the building within 50 meters around), and the architectural design drawings of the radiation diagnosis and treatment workplace (including the plan, the plan of the computer room, the profile and the ventilation map, etc.). );

(four) involving the planning and management of large-scale medical equipment configuration, it shall also provide the large-scale medical equipment configuration license or relevant approval documents approved by the corresponding health administrative department.

The administrative department of health shall organize the examination within 30 working days from the date of receiving the above materials. If it meets the corresponding national hygiene standards and requirements after examination, it shall be issued with a certificate of health examination for the design of the construction project before the construction project can start.

Twenty-third medical and health institutions should evaluate the control effect of occupational hazards before the completion and acceptance of construction projects; Those who meet the specified requirements shall apply to the corresponding health administrative department for health inspection and acceptance, and submit the following materials:

(a) the application for health inspection and acceptance of the completion of the construction project;

(two) the health inspection certificate of the construction project;

(3) An evaluation report on the control effect of occupational hazards issued by an institution recognized by the health administrative department;

(4) List of radiation diagnosis and treatment personnel;

(5) List of radiation protection and quality control equipment;

(six) radiation accident emergency plan and other corresponding rules and regulations;

(seven) the documents of the radiation protection management institution or the list of radiation protection management personnel;

(eight) other relevant information required by the administrative department of health according to law.

The administrative department of health shall, after organizing the on-site acceptance, issue a certificate of health acceptance for the completion of the construction project.