MedicSense Ltd.

MedicSense Ltd. MedicSense Ltd. was established to assist medical devices manufacturers to contend with Clinical, Regulatory and Quality Assurance requirements. MedicSense has over 20 years of experience providing services such as technical and regulatory affairs from the early stages of the product to the final stages of certification (FDA, CE, and more), design of pre-clinical and clinical trials, CRO activities, establishment of quality systems and a comprehensive range of complementary services such as European Authorized Representation, U.S. Agent, Strategic Market Review, Reimbursement, Quarterly Standards Review and more. MedicSense acts as an Israeli Registration Holder (IRH) for foreign companies that export their devices to Israel. According to the new Israeli Medical Device Law # 5772-2012 dated May 14, 2012. Medical Devices manufactured or marketed in Israel shall be registered by the Ministry of Health registrar (AMAR - The Medical Device Division of the Israeli Ministry of Health). Applications for registration shall be done only by an Israeli citizen or by a corporate established in Israel. As an IRH we (MedicSense) are independent and focused only on regulatory issues with no commercial involvement as distributors, therefore we can guarantee that the technical documentation provided to the authorities will be kept confidential, rather than with a distributor that might become your future competitor.