"In vitro" diagnostic medical devices
“In vitro” diagnostic medical devices include reagents, reagent kits, reagent products, control and calibration materials, instruments and devices, equipment or systems that are used alone or in combination with another medical device and are intended for use in “in vitro “conditions for testing biological samples, including blood and tissue samples obtained from the human organism, in order to obtain information on:
- physiological and pathological conditions
- congenital anomalies
- the safety and compatibility of potential transplant recipients
- on the data needed to monitor the therapeutic effects
Area regulated by the Law on Medicines and Medical Devices of Bosnia and Herzegovina
In our country, this area is regulated by the Law on Medicines and Medical Devices of BiH (Official Gazette of BiH, number 58/08) and the Ordinance on Medical Devices (Official Gazette of BiH, number 04/10).
“IDS – Zdrava sredina d.o.o. is the decision of the Agency for Medicines and Medical Devices number: 10-07. 12-2-11101-2/19 from 11.02.2020. registered in the Register of wholesalers of medical devices and received a license to carry out wholesale trade in medical devices of class I, IIa, IIb and III. 13.02.2021. “IDS – Zdrava sredina” d.o.o. from the Agency for Medicines and Medical Devices, it also receives approval for the wholesale trade of “In vitro” diagnostic medical devices List A, List B, List C and List D, which require storage conditions in a cold chain.”