Israel Enhances Reliance Policy – Medical Devices May Be Registered Based on Foreign Regulatory Authorities’ Approvals

The draft reflects the Ministry’s evolving regulatory approach, which adopts a model of “enabling regulation” based primarily on recognition and reliance on approvals issued by regulatory authorities in “recognized countries”. Under this framework, for certain categories of medical devices, there will no longer be a need to await a full evaluation and registration process by the Ministry prior to marketing in Israel. Instead, a risk-based model will apply, introducing differentiated registration pathways based on the product’s risk classification.

 The Proposed Amendment – What It Means

If completes the legislation process, the amendment will allow for an expedited registration process, based broadly on the internationally recognized classification of medical devices by risk level (Class I, Class IIa/IIb, and Class III). The draft regulations require applicants to submit regulatory and marketing information sufficient for product classification—such as a risk management survey and, in some cases, a clinical evaluation of the medical device. Devices will be classified and registered as follows:

1. Low-risk devices – will be submitted via a notification pathway, allowing immediate registration based on a declaration by the applicant that the product is registered or authorized for marketing in a recognized country;
2. Medium-risk devices – will be registered through a fast-track process within 45 business days, based on registration in a recognized country;
3. Medium-to-high-risk devices – will be registered through a fast-track process within 60 business days, also based on registration in a recognized country;
4. High-risk devices – will require a full evaluation.

Stakeholders may submit their comments on the draft regulations until August 1, 2025.

This is a welcome step by the Ministry of Health and is expected to ease and shorten time-to-market for medical devices in Israel. However, it is important to carefully examine the detailed mechanisms proposed and assess their feasibility in practice. To the extent that the draft regulations create gaps compared to parallel regulatory frameworks in recognized countries, those gaps should be identified and addressed.

In addition, relying mainly on foreign approvals for medical device registration could inadvertently create a bias in favor of imports, which may result in disincentives for developing and manufacturing medical devices in Israel. Supporting and maintaining local industry is of strategic importance—especially in times of global or regional complexity, where access to imported products may be disrupted.

To read the full draft amendment click here