Medical Device Regulatory Requirements in Israel

Regulatory Authority Ministry of Health
Regulatory Authority Website Link Click Here
Device Classification Israel does not have its own classification system but it recognizes USA, Europe,
Medical Device Regulations Licensing of medical equipment | Click Here
Registration Process Registration of medical equipmentInstructions for submitting an application for the registration of an AMR medical device / accessory at the Ministry | Click Here
Registration Timeline 4 months
Conformity Assessment Route

The adoption and implementation by Israel of national technical regulations, standards and conformity assessment procedures which are equivalent to those of relevant European Community Law.

| Click Here
Requirement of Authorized Representative Yes
Language Requirement Labels must be in Hebrew and Arabic (for home-use products) and English Language
Labeling Requirements

2.1.1 Registration Number
The medical device shall bear the registration number (AMR No.) assigned by the Ministry of Health.

2.1.2 Identification of the Product
The name of the product, its model, and description shall be clearly and prominently marked, and shall include the following details:

  • Manufacturer’s name and address in Hebrew, Arabic, and English.

  • The name and address of the AMR (Medical Device Registration Certificate) holder in Hebrew, Arabic, and English.

  • The product’s trade name in Hebrew, Arabic, and English (as appears in the approved registration).

2.1.3 External Packaging Labeling Requirements
The external packaging must clearly include the following:

  • The commercial name of the product in Hebrew, Arabic, and English.

  • Manufacturer’s name and address in Hebrew, Arabic, and English.

  • The name and address of the registration holder of the AMR in Hebrew, Arabic, and English.

  • Name and generic name of the product, as appears in the registration approval (if applicable).

| Click Here
Clinical Trials Information

Procedure 14 is regarding the submission, approval, management, and supervision of medical experiments and studies in humans

| Click Here
Database Medical Devices Registry | Click Here
Declaration of Conformity

The DOC documents must be up-to-date and valid for at least a full calendar year. If the manufacturer's DOC documents are up-to-date for earlier periods, an official document from the manufacturer confirming that these certificates are still valid for him and that no changes have been made to them until the date of submission can be

| Click Here
Certificate of Free Sale

The exporter must comply with Israeli medical device standards and obtain these approvals, and adhere to the renewal date before submitting documents to regulatory institutions and/or issuing shipments to these geographic areas. From now on, the Export Institute will handle the production of CFS certificates, with the certificate itself being an original certificate from the Israeli Ministry of Health. 

| Click Here
Reportable Incidents

Reporting adverse events and new safety information

| Click Here
Advertising and Promotions

Advertising of medical products under Regulation

| Click Here
Additional Information

Medical equipment will be registered in the AMR registry for a period not exceeding five years.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 06/Jul/2025

If you found this helpful, consider supporting by buying me a coffee ☕
Every little bit counts!