Israel: Implementation Outline of Reformation Plan for Medical Devices by MOH

An implementation plan for the reformation of medical device and equipment registration was released by the Israeli Ministry of Health (MOH), with the goals of reducing registration times, facilitating the import of medical devices, and enhancing the effectiveness of the healthcare system. The implementation outline is including the regulation of medical device registration and the renewal procedures.

Registration of medical devices

Class I (low-risk devices, including sterile, reusable surgical, laboratory equipment)

Immediate registration is based on self-declaration. The manufacturer is also required to submit an annual declaration along with the registration file to provide data validity and certificates for continual importation.

Class II (low-medium risk devices):

There are 2 divisions for Class II registration which are Declaration-based and Notification-based.

Declaration-based registration: From 1 October 2023, a group of Class II medical devices will be registered within 14 days from the submission date, with the condition that the medical devices have acquired approval from 2 recognized authorities and 6 months of actual marketing in 2 recognized authorities.

Notification-based registration: Registration time would take 60 days from the application submission date and involve FDA-registered Class II medical devices.

Class III: No changes to the registration process.

The Renewal Procedures

Class I: The renewal process is statement-based, requiring the attachment of a valid marketing declaration from the country of reliance, documentation of the post-market surveillance report, a statement for the regulator review report, and a statement stating the absence of unusual events (deaths, side effects, hospitalizations).

Class II and III: The renewal process is notification-based, and will be approved within 30 working days, with the condition of uploading the FDA approval and valid statement of the continual marketing authorization in the reliance country.

AMAR will grant authorization for importation permits through the route system and separate import authorization will not be granted. The product's integrity during importation and its quality are under the purview of the manufacturer or the Responsible Person.

Essential and non-essential adjustments will be made to the registration amendment. Non-essential adjustments will be noted in the declaration or notification, and an SLA (service terms agreement) will be established for the substantial changes.

Source: Ministry of Health Israel (MOH)