Israeli Registration Holder (IRH) for medical devices and registration of medical devices in Israel

All medical devices manufactured or marketed in Israel must be registered by the Medical Device Division (a.k.a AMAR) 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 Medical Device Division.

Our company is an official independent Israeli Registration Holder (IRH). We handle all responsibilities associated with registration and compliance, including: Preparation and submission of registration applications to the Medical Device Division (a.k.a AMAR). Reporting incidents or adverse events and managing all emerging compliance issues. Renewing registration on time for uninterrupted approvals. Performing post-marketing activities including preparing periodic reports. Serving as the manufacturer’s local regulatory representative and managing all communications with the registrar.

Working with an independent IRH allows you to remain the owner of your proprietary information, have full control of your local marketing options and remain unconstrained by distributor interests.

Our company is the leading consultancy group for Medical Device Regulatory, Clinical and QA services in Israel. With over 15 years of experience in development processes, from initial concept to regulatory plan, verification and validation, clinical studies, pre-marketing clearance and post-marketing compliance, we allow you to obtain clearance to market your product and ensure that you remain in compliance worldwide.

Potential partners: Manufacturers of medical devices that export to Israel.

Target countries: USA, EU, Canada, Australia, NZ, Japan, Singapore, S. Korea.

Company info:

Year of establishment: 2001
No. of employees: 18