Diagnostic Center Licensing is a complex process involving authorization for laboratory and instrumental examinations (CT, MRI, ultrasound). Diagnostic centers are high-tech medical facilities, so requirements for them are particularly strict. Emphasis is placed not only on medical permits but also on radiation safety, biosafety, and quality control. Laboratories need to demonstrate compliance with ISO standards, while radiology rooms require a license from the Nuclear and Radiation Safety Agency. An improperly planned center may never open if the building fails to meet shielding requirements.
Specialists on Legal.ge offer full legal support for diagnostic center licensing:
- Licensing Strategy: Determining which licenses and permits are needed for specific services (e.g., pathomorphology, genetics, radiology).
- Radiation Safety: Obtaining a nuclear and radiation safety license (CT, X-ray, mammography).
- Laboratory Standards: Defining Biosafety Level (BSL) and obtaining appropriate permits.
- Equipment Registration: State registration and passportization of medical devices.
- Quality Control: Legal assurance of internal and external quality control systems.
In practice, the biggest challenge is the radiation safety license. This requires a complex engineering project proving radiation will not leak outside the room. If walls are not covered with baryte plaster or lead sheets, the license will not be issued. Laboratories also need special ventilation and waste management systems. A lawyer coordinates with engineers and physicists to ensure flawless documentation.
In Georgia, this field is regulated by the Law "On Nuclear and Radiation Safety," the Law "On Licenses and Permits," and Ministry of Health orders regarding laboratory activities. Requirements vary by diagnostic type.
Working with a specialist begins with project assessment. The lawyer checks if it is feasible to install an MRI or CT scanner in the selected building. This prevents costly mistakes.
Legal.ge is your expert in medical technology law. A diagnostic center is a major investment, and we will help you protect it legally.
Updated: ...