Ministry of Health

Ministry of Health (Israel)

Regulatory Authority

Ministry of Health Medical Institutions and Devices Licensing Department

Medical Device Regulation

Medical Device Law – 2012

Official Language

Hebrew

Classification

Classes I, II and III (US FDA) and Class I, IIa, IIb, III(EU)

Registration Process

• Prepare the application dossier. This includes FDA 510(k), CE Marking Certificate, or regulatory approval from Australia, Canada, or Japan; Certificate to Foreign Government (CFG) or Certificate of Free Sale (CFS); and Proof of ISO 13485 certification.
• If not registered in a “recognized country*:” risk analysis, clinical evaluation, clinical trial information, and expert opinions are required.
• Appoint an Israel registrant to manage the application process.
• Electromedical devices require Israel Standard Institute (ISI) validation and certification. In order to get ISI validation, a sample must be submitted along with testing report documentation.
• Enter Sick Fund listing process to ensure that device can be ordered by hospitals and healthcare providers (Fund may request device sample and require local product testing).
• Israel implements a medical devices registration process that corresponds to that of the USA FDA and EU (“Two-track system”)

Documents Required

• Free Sale certificate
• ISO13485
• Application form
• other required certifications.

Applicable QMS

ISO 13485:2016

Registration Timeline

• 120 working days starting from the day the Ministry of Health acknowledges the letter of license submission.

Authorized Representative

Yes

License Validity

• Licenses issued by AMAR are subject to the expiry date of the medical device EC certificate. As regards devices with only FDA approval, expiration dates are more flexible.

Special Notes

• Labelling must be submitted in Hebrew.
• In case the medical device is intended for domestic use, the labelling and instructions for use must be provided in English, Hebrew and Arabic.
• In the event that the product is intended for professional use only within health facilities, the labelling and instructions for use may only be in English.
• Official certification documents do not need to be translated if they are in English.