Medical Device Registration in


Medical Device Registration in Belgium

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



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

ISO 13485:2016

Registration Timeline

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

Authorized Representative


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.

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