This week, AmCham and the Association of Medical Devices Entrepreneurs (DISMED) met with representatives from the Ministry of Health, as well as from the Medicines and Medical Devices Agency. The discussions focused on the draft Law on medical devices, as well as the subsidiary normative acts. It has been emphasized the need to adjust the fees for state registration of medical devices, as well as to provide a clear mechanism for registering generic groups of devices under a single dossier. The parties have agreed to create a working group in order to continue the dialogue on this matter.
If you have any questions please contact Elena Popic, Policy Officer at 211 - 781 or firstname.lastname@example.org