Health bureaus of all provinces, autonomous regions and municipalities directly under the Central Government, Health Bureau of Xinjiang Production and Construction Corps, Health Supervision Center of Ministry of Health, and China Center for Disease Control and Prevention:
In order to implement the Regulations on the Administration of Radiological Diagnosis and Treatment, guide and standardize the work of radiation diagnosis and treatment licenses in various places, according to the provisions of the Measures for the Administration of Health Administrative Licensing and relevant laws and regulations, our department has formulated the Measures for the Administration of the Issuance of Radiological Diagnosis and Treatment Licenses, which are hereby printed and distributed to you, and put forward the following requirements:
First, please the provincial health administrative departments according to the actual situation in the region to develop specific procedures for the issuance of local licenses, and put forward requirements, seriously organize the implementation. It is necessary to extensively carry out publicity and implementation activities and technical training to ensure the smooth issuance of radiation diagnosis and treatment licenses.
Two, radiation treatment licensing work should be carried out in strict accordance with the corresponding laws, regulations, standards, norms and procedures, for violations of law found in the licensing work, should be corrected and investigated according to law.
Three, we should give full play to the role of social supervision, in accordance with the standardized procedures in a timely manner to inform the community about the area of radiation diagnosis and treatment license.
Four, our department will timely organize spot checks on the issuance of radiation treatment licenses in some provinces and cities, and the results of spot checks will be announced to the public through the notification form of the Ministry of Health.
The annex of this notice can be downloaded from the website of the Ministry of Health. For specific problems in implementation, please contact the Health Supervision Bureau of our Ministry. Article 1 In order to implement the Regulations on the Administration of Radiological Diagnosis and Treatment and standardize the issuance of radiation diagnosis and treatment licenses, this procedure is formulated in accordance with the Measures for the Administration of Health Administrative Licensing and the provisions of relevant laws, regulations and rules.
Article 2 The health administrative department of the local people's government at or above the county level shall be responsible for handling matters related to the licensing of radiation diagnosis and treatment according to this procedure, and perform the duties of supervision and management of radiation diagnosis and treatment according to law.
Article 3 The health administrative department at the provincial level may, in accordance with the provisions of this procedure and in combination with the actual situation in this region, formulate the specific implementation procedures for the licensing of radiation diagnosis and treatment within its administrative region.
Article 4 The administrative department of health shall follow the principles of openness, fairness, impartiality and convenience when issuing the license for radiation diagnosis and treatment, and announce the name, location, acceptance and examination and approval conditions, acceptance time and examination and approval period of the accepting institution.
Article 5 Medical institutions shall apply to the local health administrative department in accordance with the procedures to carry out radiation diagnosis and treatment, and can only engage in radiation diagnosis and treatment within the permitted scope after obtaining the Permit for Radiation Diagnosis and Treatment and the registration of corresponding diagnosis and treatment subjects. Article 6 A medical institution shall submit the application materials to the local health administrative department when applying for the Permit for Radiological Diagnosis and Treatment.
The application materials mainly include:
(1) Application Form for Radiological Diagnosis and Treatment Permit (with1);
(2) Practice License of Medical Institution (photocopy) or Approval Letter for Establishment of Medical Institution (photocopy);
(3) professional and technical post qualification certificate of radiation diagnosis and treatment personnel (copy);
(4) List of radiation diagnosis and treatment equipment.
Where (1) and (4) shall be submitted to the electronic version at the same time.
Other materials to be provided:
(1) Radiological diagnosis and treatment equipment subject to configuration license management still needs to submit the Configuration License Certificate for Large Medical Equipment (photocopy);
(2) Radiation work hygiene license or radiation safety license (copy);
(three) this year's radiation diagnosis and treatment equipment protection performance test report (copy);
(four) if it is a new construction, renovation and expansion project after the implementation of the Regulations on the Administration of Radiological Diagnosis and Treatment, it is also necessary to submit the Certificate of Completion and Acceptance of Radiological Diagnosis and Treatment Construction Project (photocopy).
Article 7 A medical institution shall apply to the local health administrative department for permission according to the categories of radiation diagnosis and treatment:
(1) Medical institutions that use X-ray CT machines, CR, DR, ordinary X-ray machines or dental and breast X-ray machines to carry out X-ray image diagnosis shall apply to the health administrative department at the county level.
(2) Medical institutions that carry out the radiation diagnosis work listed in Item (1) and carry out the interventional radiation diagnosis and treatment work at the same time shall apply to the municipal local health administrative department with districts.
(3) Conduct the radiation diagnosis and treatment listed in (1) and (2) while using gamma knife, X knife, electron linear accelerator, proton therapy machine, neutron therapy machine, heavy ion therapy machine, cobalt -60 machine, afterloading therapy machine, deep X-ray machine, applied therapy source, PET, SPECT, gamma camera, gamma bone densitometer, particle implantation therapy source or
Article 8 The application materials shall be true and complete, and the original shall be stamped with the official seal of the applicant.
To meet the acceptance conditions, the local health administrative department shall accept the application within 5 working days, and issue an application acceptance notice to the applicant.
Do not meet the acceptance requirements, the local health administrative department shall issue a notice of rejection to the applicant within 5 working days. The notice of rejection shall state the reasons for rejection. Article 9 The local health administrative department shall examine the application materials for radiation diagnosis and treatment license submitted by medical institutions, and may conduct on-site examination when necessary.
Tenth on-site audit work should have more than 2 staff. The composition of auditors should meet the legal knowledge and professional technical ability required for auditing. Auditors shall strictly abide by the relevant provisions, and shall not have economic interests with the audited entity or project, and shall not charge fees from the audited entity or seek other illegitimate interests.
Article 11 On-site auditors shall verify the contents listed in the application materials of medical institutions, fill in the On-site Audit Form for Radiological Diagnosis and Treatment Permit (Annex 2), issue on-site audit opinions, and give a conclusion of "suggested approval", "suggested rectification" or "suggested disapproval".
Twelfth local health administrative departments from the date of acceptance, make a review decision within 20 working days.
Thirteenth audit conclusion is "recommended for approval", the local health administrative department shall perform the examination and approval procedures, and issue a "radiation diagnosis and treatment license".
Article 14 An applicant shall apply to the health administrative department that issued the Practice License of Medical Institution for registration of the corresponding radiation diagnosis and treatment subject with the Permit for Radiation Diagnosis and Treatment. The registration procedure shall be implemented in accordance with the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions.
Fifteenth audit conclusion is "suggested rectification", the local health administrative department shall issue a "rectification notice" to the applicant.
The applicant shall, within three months from the date of receiving the rectification notice, make rectification as required and submit a rectification report to the local health administrative department. The rectification period is not counted in the license period. If the rectification is not completed as required within the time limit, a written explanation shall be given to the administrative department of health.
Sixteenth local health administrative departments shall complete the examination within 20 working days from the date of receiving the rectification report, and put forward the examination opinions.
Article 17 If the conclusion of examination or review is "it is suggested not to grant permission", the local health administrative department shall examine and make a decision not to grant permission, issue a "Decision on Not Granting Administrative Permission" to the applicant, and explain the reasons for not granting permission. Article 18 A medical institution's Permit for Radiological Diagnosis and Treatment shall be checked together with its Practice License for Medical Institution, and the health administrative department that issued the Practice License for Medical Institution shall be responsible for the specific verification. Medical institutions shall submit the following materials:
(a) the original and a copy of the Permit for Radiological Diagnosis and Treatment;
(two) the list of radiation diagnosis and treatment equipment and personnel and their changes;
(3) Personal dose monitoring, health examination, education and training of radiation workers;
(four) radiation protection and quality control management and inspection and test report;
(five) the occurrence and handling of radiation accidents.
The verification department shall, within 30 working days from the date of receiving the application, review the application materials, and if necessary, may invite relevant professional and technical personnel or professional and technical management departments to put forward evaluation opinions, and if they meet the requirements, they shall be verified; Do not meet the requirements, put forward rectification opinions and require medical institutions to rectify within a time limit.
Article 19 Where a medical institution changes the radiation treatment site, treatment equipment or treatment project, it shall, in accordance with the requirements of Articles 6 to 8 of this Regulation, apply to the health administrative department with the power to examine and approve the change project, submit the application materials, and indicate the contents of the change in the application materials.
Article 20 The local health administrative department shall go through the formalities for changing the license for radiation diagnosis and treatment in accordance with the provisions of Articles 9 to 17 of this procedure.
Twenty-first medical institutions in any of the following circumstances, the original license of the local health administrative department to cancel the license for radiation diagnosis and treatment, and make an announcement:
(a) medical institutions to apply for cancellation;
(2) Failing to apply for verification within the time limit or changing the subject of radiation diagnosis and treatment without authorization;
(three) after verification or change does not meet the relevant requirements, and failed to improve or improve still does not meet the requirements;
(four) to suspend or stop the subject of radiation diagnosis and treatment for more than one year;
(five) the "Practice License of Medical Institutions" and the large-scale medical equipment configuration license have been revoked according to law. Twenty-second medical institutions that have obtained the Permit for Radiological Diagnosis and Treatment shall be hung in a prominent position and accept supervision; It is strictly prohibited to forge, alter, transfer, lend or resell.
Article 23 If a medical institution loses its Permit for Radiological Diagnosis and Treatment, it shall promptly publish a notice of loss reporting in the major newspapers and periodicals where the issuing authority is located, and apply to the original issuing authority for a replacement within 30 days after the announcement.
Twenty-fourth local health administrative departments at or above the county level shall establish and improve the supervision and management system for the issuance of radiation diagnosis and treatment licenses.
Twenty-fifth inspection found or received a report and verified in any of the following circumstances, the health administrative department that made the decision on the license for radiation diagnosis and treatment or the health administrative department at a higher level shall revoke the license for radiation diagnosis and treatment:
(1) The medical institution has obtained the Permit for Radiological Diagnosis and Treatment by cheating, bribery or other improper means;
(two) the health administrative department staff abuse their powers, neglect their duties, and issue a "radiation treatment license" to unqualified applicants;
(three) the health administrative department staff beyond the statutory authority to issue the "radiation diagnosis and treatment license";
(4) Other circumstances that can be revoked according to law.
Article 26 Local health administrative departments at or above the county level shall establish an information management system for radiation diagnosis and treatment licenses, inform each other about the licensing management of the issuance and cancellation of radiation diagnosis and treatment licenses, and regularly publish the list of medical institutions that have obtained and cancelled radiation diagnosis and treatment licenses within their respective jurisdictions.
Article 27 This procedure shall be implemented as of the date of promulgation.
Attachment: 1 Application form for radiation diagnosis and treatment license
2. Radiological diagnosis and treatment license on-site audit form