Licensing

Opening of a computed tomography center involves many bureaucratic procedures. The main requirement is to obtain a license for providing CT services. Diagnostics is associated with the presence of special technical installations, the work of which is regulated by the legal norms. Tomographic examinations deal with radiation, so both the radiologist and the equipment are imposed by the stringent requirements.

The licensing decisions for the opening of the CT center are made by three main institutions:

  1. State Service of Consumer Rights Protection and Human Welfare.
  2. The Ministry of Health of Ukraine.
  3. The State Nuclear Regulatory Authority

All medical institutions that make use of ionizing radiation sources in their work are subject to this licensing. All types of medical centers, private health care institutions and clinics should apply for permission, regardless of the legal form of the subject. The availability of such a document in the institution is a guarantee of the medical staff competence, the compliance of the equipment with the prescribed standards and the eligibility for conducting CT examinations.

Documents for Licensing

Regulatory submission package should include:

  • CT center project, including all its sections;
  • technical passport of equipment, certificate of conformity, registration certificate of medical equipment, certificate of equipment installation from a company that has a permission to install such equipment;
  • documents of the doctor, who performs diagnostics;
  • premises lease or sales agreement;
  • sanitary and epidemiological report, radiation measurement protocols;
  • LLC certificate or the registration of private entrepreneurship.

Successful undergoing of all the inspections results in obtaining a sanitary passport and a license from the State Nuclear Regulatory Authority for the operation of the CT center for a period of three years. On the expiry of the term, the license is renewed, suspended or canceled depending on the results of subsequent inspections and the existence of violations during the activity period. Medical diagnostic activity is prohibited by law if there is no СT operating license.

Obtaining a License with the Help of Assist Medical

Assist Medical Company offers assistance with quick obtaining of a license for CT services. We carry out:

  • supplies of tomographic devices with all documents on them;
  • installation of equipment with the signing of the installation certificate;
  • preparation of premises in compliance with security measures in it;
  • staff training;
  • preparation of internal documentation (personnel documents, job descriptions, regulations, instructions, fire safety registers and plans, labor protection, sanitary and epidemiological documents).

To obtain a permit for the CT activity, we will collect a full package of documents, submit applications to the controlling services on behalf of the medical institution, and take over the presentation of documents to the commission. In addition, once the License and the Sanitary Passport obtained, we offer further support for the work of the medical center. Our services include report writing, submission of statistics, informing the Ministry of Health of the changes in accordance with licensing conditions.

You can also order sets of legal documents from us:

The “Template” package  is a set of standard documents for obtaining a license from the State Nuclear Regulatory Inspectorate of Ukraine for the activities in the field of nuclear energy use (use of ionizing radiation sources).

This package includes 27 documents and legal advisory support in the form filling within 2 (two) months from the date of purchase.
Document processing time is 3 working days.
The language of the documents is Ukrainian.
The documents are provided in Word format.

The ‘Standard’ package  is a set of ‘turnkey’ documents for obtaining a license from the State Nuclear Regulatory Inspectorate of Ukraine for activities in the field of nuclear energy use (use of ionizing radiation sources).
This package includes 27 documents and legal advisory support in obtaining a license and fulfilling licensing conditions within 4 (four) months from the date of purchase.
Document processing time is 14 working days.
The language of the documents is Ukrainian.
The documents are provided in Word format.

The “Turnkey License” package  is a complete package of documents and representation of your company in front of the commission of the State Nuclear Regulatory Inspectorate of Ukraine when obtaining a license for carrying out activities in the field of nuclear energy use (use of ionizing radiation sources).
This package includes documents preparation and full legal support until the license is received + legal advisory support for fulfilling the license conditions within 2 (two) months from the date of the license receipt.
Document processing time is 3-6 months.
The language of the documents is Ukrainian.
The documents are provided in Word format.