Israel – excellent market opportunities for foreign Medical Device companies

Israel – excellent market opportunities for foreign Medical Device companies

21.11.2018 – The Israeli market is one of the largest consumers of medical technology in the Middle East.

Only 38.4% of the demand for medical products is produced in the domestic market; 61.6% of the demand is covered by imported goods. The main customers for medical facilities and large-scale equipment are hospitals, predominantly the 339 hospitals, of which the 44 general hospitals are mostly run by the state or charitable organisations. Continue reading

Big Changes by MDR

Big Changes by MDR

28.09.2018 – The MDR (Medical Devices Regulation) has been adopted on the 5th April 2017 and will replace the MDD (Medical Devices Regulation) and AIMDD (Active Implantable Medical Devices Directive). There is a transition period of 3 years making the regulation fully applicable in May 2020. There are massive changes compared to the MDD confronting manufacturers with numerous challenges. Further details can be found here.

The IVDR (In Vitro Devices Regulation) has been adopted on the 5th April 2017 and will replace the IVDD (In Vitro Devices Directive).  There is a transition period of 5 years making the regulation fully applicable in May 2022. There are massive changes compared to the IVDD confronting  manufacturers with numerous challenges. Further details can be found here.