The National Public Health Agency will be empowered to supervise and check the medical devices, including in the field of radiological and nuclear safety. The relevant amendment to the law on medical devices was given a first reading by Parliament, IPN reports.
The Agency will issue prescriptions, will impose penalties and restrictive measures, will monitor business entities’ actions aimed at fulfilling prescriptions and removing violations and will analyze reports on the risks related to medical devices.
To be able to import, fabricate and sell medical devices and optical tools and to provide technical assistance or repair services for such devices, the entrepreneur will be obliged to have at least one specialist in the field or a bioengineer. Drugstores and medical optical shops will be an exception.
Other changes provide that the centralized purchases of medical devices and maintenance services will be made by the Center for Centralized Procurement in the Health Sector.
