AmCham Continues the Dialogue on Medical Devices Legislation

  • 26.08.2016

On 26 August, AmCham participated at the first meeting of the Working Group created by the Ministry of Health, gathering representatives of public authorities and business community involved in the medical devices sector. In line with the previously established objectives, the parties have agreed to negotiate on a set of mutually acceptable criteria for grouping medical devices in order for these to be registered under a common dossier.

Additionally, it has been decided to examine the possibility of engaging an independent expert on matters related to the adjustment of fees applicable for state registration of medical devices. On this issue, the Medicines and Medical Devices Agency has assumed the responsibility to analyze and make available to all concerned parties the necessary financial data. The authority has also expressed its willingness to undergo the process of fees recalculation for the registration service.

If you have any questions please contact Elena Popic, Policy Officer at 211 - 781 or

Latest Advocacy on the Go