Medical device registration and submissions in Israel

Medical device registration and submissions in Israel

2020-08-30T12:28:49+00:00March 25th, 2019|

Medical device registration and submissions in Israel

In Israel, the regulatory body that is responsible for medical device registration, submissions, supervision and control over the manufacture, assembly, sterilization, import, and marketing of medical devices is the Medical Device Division of the Ministry of Health of teh State of Israel (“AMAR”).

The medical device division is responsible for granting various types of import permits for medical devices, monitoring the marketing process of medical devices and publishing documents, guidelines and procedures that assist in the import process of medical devices that are manufactured abroad and imported into Israel.

The Medical Device Division is also the unit concerned with the licensing and supervision process for all kinds of medical devices, including those for rehabilitation, implants, measuring and monitoring devices, drug injection devices, software, cellular apps, mobility devices and combination products (per the second amendment of the medical devices law). The Medical Device Division (“AMAR”) deals with everything from granting permission for registration in the registry of medical devices, to issuing export permits to local manufacturers and import permits to importers of foreign-manufactured medical devices.

Israel does not have its own medical device classification system, but recognizes the classifications from the following authorities, upon submission by the sponsoring company of documented evidence of approval from one of the GHTF countries:

  • US FDA 510(k) clearance or PMA approval
  • CE mark certificate issued by a European Notified Body
  • Certificate to Foreign Governments (CFG) or Certificate of Free Sale (CFS) from the country of origin.

For companies that have already obtained approval for their medical devices in one of these markets (particularly Europe and the US), registration is relatively “straightforward”.

If the device is not registered in one of the GHTF countries, you will need to submit the following documents to the “AMAR” Division:

  • Risk Analysis
  • Clinical evaluation
  • Clinical trial data
  • Expert opinion

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What is the Israeli registration holder (IRH)?

According to the medical devices law of Israel, the registration “owner” must be an Israeli agent of a manufacturer/rights owner that is located outside Israel.

The registration procedure must be carried out by an Israeli Registration Holder (IRH). In many ways, this IRH position reflects the US FDA and EU regulatory models.

Applications for registration can only be performed by an Israeli citizen or by an organization established in Israel.
Foreign companies intending to export their devices to Israel will thus need to assign a third party in Israel with the appropriate knowledge to function as the Israeli Registration Holder (IRH), who will oversee the medical device registration process and maintain any approvals granted by “AMAR”.

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IRH responsibilities and requirements for medical device import into Israel

  1. Reside and maintain a place of business in Israel
  2. Business license
  3. ISO 9001:2015 certification
  4. Prepare and submit registration applications to AMAR
  5. Review and approve the first batch of devices to be marketed in Israel as requested by AMAR
  6. Provide professional support and clarifications to any questions from AMAR concerning the registered product
  7. Report adverse events to AMAR
  8. Renew registrations on time to keep the market approval active and to assure a continuous supply of devices to the market
  9. Receive documents on behalf of the legal manufacturer and submit as required to AMAR
  10. Review, assess and report per postmarketing requirements, including:
  • Evaluate information provided by physicians, patients and costumers
  • Forward the information to the medical device manufacturer
  • Prepare periodic postmarketing reports
  • Report adverse and unexpected events occurring in Israel or in other countries where the device is in use
  • Report restrictions from other regulatory bodies concerning the registered medical device

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    Additional requirements for medical device registration in Israel

    Some electromedical devices also require Israel Standard Institute (ISI) validation and certification in order to ensure product quality and safety. To obtain ISI certification, you need to submit a sample of the medical device along with supporting documentation to the ISI for evaluation.

    The official certification documents do not need to be translated if they are in English.
    If the medical device is intended for domestic use, the labeling and instructions for use must be provided in English, Hebrew and Arabic.
    If the device is intended for professional use only within health facilities, the labeling and instructions for use may be only in English.

    Renewal of medical device registration in Israel

    About 4 months prior to the expiry of the existing approval from AMAR, a medical device renewal form must be submitted.
    Once the dossier has been submitted, the registration can be considered to have been extended until the Health Ministry’s decision concerning the renewal.

    Biochem has been advising biomedical companies for more than 13 years.
    Contact us for medical device registration in Israel.
    To get in touch, click here

    Bio-Chem

    +972-72-2337710

    info@bio-chem.co.il

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