Medical Device Registration in
Israel
Ministry of Health
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)
Medical Device Registration in Israel
- 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
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.