Israel Registration Holder for Medical Device and IVD Manufacturers

Ensure seamless registration and compliance with Israel’s AMAR through dedicated Israel Registration Holder services, offering expert guidance and ongoing support for market access and regulatory control.

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Israel Device Registration and AMAR Compliance

To legally sell a medical device in Israel, you must first register your device with AMAR, the division of the Ministry of Health (MOH) that regulates medical devices. AMAR device registration requires prior approval in a reference market (specifically Australia, Canada, Europe, or the United States). You will also need to comply with labeling requirements, supply quality management system certification (such as an ISO 13485 certificate), and foreign manufacturers will need an in-country representative, known as an Israel Registration Holder (IRH).

What is an Israel Registration Holder for medical devices?

The Israel Registration Holder (IRH) is a legal entity located in Israel that acts as a liaison between your company and the Ministry of Health. The IRH is responsible for registering your medical devices and IVDs with AMAR, as well as renewals and modifications to these registrations. The IRH verifies that all medical devices and IVDs meet the safety and quality standards set out by the MOH. This task includes verifying that the legal manufacturer has carried out the correct conformity assessment on its device and fulfilling post-market surveillance activities, including incident reporting, recalls, and change notifications.

Isreal Registration Holder for Medical Devices and IVDs

Why you need an independent IRH

While it is possible to use a distributor as your IRH, there are regulatory and financial benefits of designating an independent service provider. Most distributors do not have the capacity, expertise, and specialization to fulfill the mandatory responsibilities and associated liabilities that come with this role.

Your IRH should protect the confidential design information in your technical documentation, report incidents and non-conformances no matter where they occur in the supply chain, and act in the best interest of your business, even when that means changing distributors. However, distributors can encounter conflicts of interest in incident reporting or distribution changes. A distributor may not keep you up to date on regulatory developments that affect your devices. An independent IRH allows you to form a long-term partnership with an expert in regulatory compliance so there are minimal disruptions to your business.

MedEnvoy is an experienced IRH for medical device companies

MedEnvoy is a regulatory consulting firm and in-country representative provider that helps small- and medium-sized medical device companies succeed in international markets. In collaboration with our partner in Jerusalem, Regi-Medical Ltd (REGI-MEDICAL), we can act as your Israel Registration Holder. REGI-MEDICAL’s extensive knowledge of Israel’s evolving regulatory framework allows us to help you gain access to the Israeli market.

With MedEnvoy / REGI-MEDICAL as your IRH, you will maintain regulatory control over the placement of your devices on the Israeli market and maintain post market regulatory compliance.

How we can help:

Liaise with Israeli medical device regulators

We will act as an intermediary between you and AMAR throughout the registration process and for ongoing post-market activities, including record-keeping, post-market surveillance (PMS), and vigilance reporting.

Appear as your IRH on product labeling and documentation

You will be authorized to place REGI-MEDICAL’s name, address and phone number on your outer packaging, and Instructions for Use.

Document review and registration templates

Our team will review all your relevant information and documentation needed to establish compliance. We can provide a Declaration of Foreign Manufacturer and any other templates necessary to complete registrations. We will also furnish general information and guidance about labeling and translation requirements.

Post-market compliance and importation support

We will provide ongoing registration support for your product(s) with the AMAR, including renewals and modifications where needed, as well as import permits.