Medical Devices Assessment Department
- Performs evaluation of the conformity and registration of medical devices;
- Develops, maintains and updates the LATMED – register of medical devices what contains information on the medical devices, manufacturers, distributors, clinical trials, as well as vigilance reports;
- Evaluates the conformity of clinical trials documentation, makes a decision on the issuing of permission for realization of clinical trials of medical devices and supervises trials procedure;
- Performs supervision on safety of medical devices, ensures the well timed flow of information about danger for healthcare services receivers and users of medical devices, who can be under the threats of risk. In the case of threats provides and supervises the corrective actions.