Medical Devices

National legislation

ACTS

  • Medical Devices Act (Official Gazette, no. 76/13)

ORDINANCES

  • Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, no. 84/13)
  • Ordinance on Specific Requirements for Medical Devices Manufactured Utilising Non-Viable Animal Tissues (Official Gazette, no. 83/13)
  • Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13)
  • Ordinance on Good Practice in the Wholesale Distribution of Medical Devices and on the Conditions for Registration in the Register of Wholesale Distributors of Medical Devices (Official Gazette, no. 125/13)
  • Ordinance on the Conditions for the Retail Sale and Issue of Authorisations to Specialised Outlets for the Retail Sale of Medical Devices (Official Gazette, no. 133/13)