The level of approval is different for different radiotherapy programs.
General medical diagnostic programs (such as ordinary filming, fluoroscopy, CR, DR, etc.), there are county-level health administrative departments for approval; while CT, intervention, etc., by the municipal level for approval; gas pedal, nuclear medicine, etc., by the provincial level for approval. If your hospital has both gas pedal and CT, X-ray machine, then go directly to the provincial level for approval.
Radiological diagnosis and treatment license approval (provincial approval) to submit the relevant materials, the requirements are as follows (provinces are different, may be slightly different):
(a) the initial application
1, radiological diagnosis and treatment license application form;
2, radiological diagnosis and treatment license municipal health supervision institutions preliminary examination opinion;
3, "medical practice license
3, "medical institutions license" (copy) or "set up a medical institution approval" (copy);
4, radiotherapy professional and technical staff list and radiotherapy staff professional and technical qualifications (copy);
5, radiotherapy equipment list;
6, the current year's radiation diagnostic and treatment equipment protection, performance testing report;
7, After 2007, the new radiation diagnosis and treatment equipment, belonging to the configuration of permit management, need to submit large medical equipment configuration permit documents (copy);
8, "Radiological Diagnosis and Treatment Management Regulations" after the implementation of the new construction, alteration, expansion projects, need to submit radiological diagnosis and treatment of the construction project completion inspection and acceptance of the certificate (copy);
9, "Radiation Safety License" ( copy).
(B) change the licensing program
Medical institutions to change the name, legal representative, address, radiotherapy premises, diagnostic equipment or diagnostic and treatment projects, must be changed to the health administrative department with the right to approve the change of the project to apply for change procedures.
1, the medical institutions to change the name, legal representative or person in charge, address (not relocation), should first apply for "medical institutions license" change, and then apply for "radiological diagnosis and treatment license" change, the materials to be submitted:
(1) Radiological Diagnosis and Treatment License Change Application Form;
(2) "Medical Institutions Practice License" (a copy of a copy of a copy of a copy of a copy of a copy of a copy of a copy);<
(3) The original and copy of the Radiological Diagnosis and Treatment License;
(4) Change of the name and address of the unit (not relocated): the local establishment department or the department that approves the change needs to be provided with the documents issued by the department. Change of legal representative: the original and copy of the supporting document issued by the competent (superior) department of the unit, i.e., the appointment decision, are required.
2, the address of the medical institution remains unchanged, only changes in radiotherapy premises, diagnostic and treatment equipment or diagnostic and treatment projects, the materials to be submitted:
(1) Radiotherapy License Change Application Form;
(2) "Radiotherapy License," the original copy of the original;
(3) (a) in the 2,3,4,5,6,7,8,9 of the material listed, and indicate the changes in the application materials.
3, change of address (relocation) of the medical institution shall apply to the administrative department of health to re-apply for a "radiotherapy license", according to the initial application to submit materials.
(C) verification
Medical institutions, "Radiology License" verification and "medical license" verification, and by the issuance of "Radiology License" of the administrative department of health is responsible for the specific verification. Verification should be three months before the expiration of the verification to the licensing authority to apply for verification, verification of medical institutions should submit the following materials:
1, radiology license verification application form;
2, radiology license verification of municipal health supervision bodies for initial review;
3, "radiology license" is, copy (original);
4, "medical institutions License (copy);
5, summary of radiotherapy work in the verification cycle;
6, list of radiotherapy equipment, personnel list and changes;
7, personal dose monitoring reports, health inspection reports and education and training reports of radiological staff in the verification cycle;
8, radiotherapy equipment protection, performance test reports in the verification cycle;
9, radiotherapy Protection and performance test report of the equipment;
9. Report on the occurrence and handling of radiation incidents.
(D) the loss of replacement
Medical institutions lost the "radiotherapy license" should be promptly published in the major local newspapers and magazines, the loss of the notice, and within one month after the announcement of the 30th to the original licensing department to apply for a replacement, the application for replacement should be submitted to the following materials:
1, a written application for replacement of the license (should be signed by the legal representative of the medical institution to confirm the signature and stamp the official seal of the unit)
2, the original newspaper announcement of the loss and declaration of invalidity;
3, "Radiological Diagnosis and Treatment License" original or copy (both lost to provide the license number).
(E) reporting requirements:
1, all types of forms can be downloaded directly from the health supervision network ();
2, reporting requirements for printing, Chinese use of the Song font small 4 characters, the English use of 12 characters. All materials (originals and copies) are on A4 paper in duplicate.
3. The name, model and quantity of equipment in the application, equipment list and test report should be the same.
4, the declaration of the contents should be true and complete, application materials in the copy should be clear and consistent with the original; all application materials should be stamped page by page with the official seal of the applicant.
5, the application form, personnel list and equipment list reported an electronic version.