Oct 2013

Authors: Adi Ickowicz BSc, ME and Seth Goldenberg, PhD

Excerpt:

In May 2012 Israel’s parliament passed new legislation requiring all medical devices manufactured or marketed in Israel to be registered with AMAR, the Medical Device Division of the Israeli Ministry of Health. According to the new law, applications for registration can be done only by an Israeli citizen or by a corporation established in Israel. Companies intending to export their devices to Israel will thus need to appoint a third party in Israel with the appropriate knowledge and skills to function as the Israeli Registration Holder (IRH), who will oversee the medical device registration process and maintain any approvals granted by AMAR. The new regulations will have the biggest impact on small to medium-sized companies outside of Israel who may not have a registered office in Israel and are only carrying out sales through local distributors. Using an independent IRH will provide more freedom when selecting distributors or when changing distributors, and will keep confidential company information independent of these changes and in the hands of a professional entity without commercial interest in the product.