The new Israeli Medical Device Law -- MEDICA Trade Fair


MedicSense Ltd.

The new Israeli Medical Device Law

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.

Section 3(d) of the law states that the submission to AMAR can be done through a professional and skilled third party, the Israeli Registration Holder (IRH). MedicSense is a Israeli Clinical and Regulatory Affairs consultancy firm with more than 20 years of experience in Regulatory Affairs and liaison with the Israeli Ministry of Health.

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. In addition MedicSense's name and address appear in the Israeli certificate and labeling so there is no need to reprinting them should you decide to switch distributors for business reasons. Switching distributor sometime can be difficult because you need the cooperation of the former distributor to change the registration and name it under the new distributor.

As part of the IRH service we are also responsible to for being in contact with the ministry of health, reporting of incidents/cases (vigilance) and providing post marketing surveillance reports as required by law.