MedicSense Logo Clinical and Regulatory Affairs Consulting

Navigate the Israeli regulatory maze with confidence & control

All medical devices manufactured or marketed in Israel must now be registered by AMAR- the Medical Device Division of the Israeli Ministry of Health. Companies that would like to export their devices to Israel must appoint an Israeli Registration Holder (IRH) to handle the registration and maintain approvals granted by the AMAR division.

Putting Control Back in Your Hands

MedicSense, Israel’s longest standing authority in clinical and regulatory affairs helps companies navigate the international clinical and regulatory maze while allowing you to remain the owner of your proprietary information, have full control of your local marketing options and remain unconstrained by distributor interests.

Benefits

  • Continuous Compliance – obtain clearance to market your products in Israel and stay in compliance over the long term.
  • Objectivity – work with a 3rd party IRH that protects your interests by focusing exclusively on regulatory affairs, without commercial interest in your products.
  • Trust – management of confidential business and product information with complete discretion.
  • Expertise – over 20 years of regulatory experience and strong insider liaisons with Israeli regulatory and certification authorities.
  • Personal attention – get your products past regulatory hurdles with innovative, responsive and pragmatic solutions.

Contact us to learn more