Israel medical device regulatory resources

REG-2023/04: the registration certificate is sent immediately after the application is accepted in the registration system, and no later than 48 hours; non-conforming submissions receive an automatic rejection reply within 4 hours.

Eligibility: Class I (incl. Is/Im/Ir) devices and low-risk IVDs already registered and marketed in a recognized state.

REG-2024/06: new registrations handled within up to 45 working days; renewals within up to 10 working days; substantial changes up to 45 and non-substantial changes up to 10 working days.

Eligibility: Class II with an FDA 510(k)/De Novo approval and 4 months of US marketing; EU Class IIa or IVD Self Test (IVDD)/class B (IVDR) with a recognized-state approval and 4 months of marketing. Requires a lawyer-affirmed affidavit; AMAR publishes this clock by track and channel, not by risk class.

REG-2024/06: new registrations and renewals handled within up to 60 working days; substantial changes up to 60 and non-substantial changes up to 10 working days.

Eligibility: EU Class IIb or IVD LIST B (IVDD)/class C (IVDR) with approvals from two independent regulatory authorities (e.g. EU and FDA) and 6 months of marketing (with an FDA approval, actual US marketing is not required). Change applications are also open to Class III and high-risk IVDs, but the substantial-change option does not exist for Class III; AMAR publishes this clock by track and channel, not by risk class.

AMAR publishes a handling target of 120 days for regular-track new, renewal and change applications; devices not eligible for the declaration or fast tracks use this route.

AMAR publishes this target by track, not by risk class.