2021-05-25T18:26:24+00:00February 25th, 2021|

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.

Medical device registration and submissions in Israel - Bio Chem

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

Our services

Medical device registration and submissions in Israel - Bio Chem
Medical device registration and submissions in Israel - Bio Chem
Medical device registration and submissions in Israel - Bio Chem
Medical device registration and submissions in Israel - Bio Chem
Medical device registration and submissions in Israel - Bio Chem
Medical device registration and submissions in Israel - Bio Chem

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”.

Research and development

Consultancy in a variety of areas including design, research labs and clean rooms, development technologies, investor business presentations, regulatory strategy, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC, professional training.

read more

Design and engineering

Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation with a combination of theoretical knowledge, practical experience, and in-depth understanding of the biometrics regulation and principles and in accordance with the GxP principles.

read more

Manufacture and packaging

Consultancy in manufacturing plant design, development and engineering of manufacturing processes, selecting the most appropriate technology, process gable, technology transfer, GMP, process improvement, utilization optimization and improvement, employee training and equipment validation, systems, production processes and cleaning.

read more

GXP, Quality Validation

Advises, establishes, accompanies and upgrades systems of various types of quality management, executes GMP trainings and courses, assimilates the company’s GxP principles, ISO 13485, assures quality and prepares for global regulatory audits while conducting risk analysis and evaluation, equipment, systems, software, testing methods, manufacturing processes. And cleanliness until successfully audited.

read more

Regulation and registration

Regulatory consulting and drug registration, EMC, CE Mark, nutritional and cosmetic supplements in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and requirements in a professional manner, in a short time, outlining the product, shelf life and graphics, import certifications and meetings with regulatory bodies and up to approval .

read more

Software and systems

Digital healthcare consulting, software development and medical applications in accordance with 21CFR part 11 / Annex 11 / HIPAA / GDPR requirements, ISO 13485/27001/27799, CE marking, Risk Assessment, and software validation and control systems up to marketing approval.

read more

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

    לפרטים נוספים

    For further details

    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.

    Share This Article on Social Media

    Eran Yona Bio-Chem Founder and CEO

    Bio-Chem has been advising biomedical companies for more than 15 years.

    Contact us for medical device registration in Israel.
    To get in touch, Click here Or email us: [email protected]

    Articles we wrote for your use

    Validation for ERP Priority and SAP systems at Pharma and Medical companies

    מהי ולידציה למערכות ERP פריוריטי? מערכת ERP היא מערכת ממוחשבת לתכנון משאבי הארגון והיא נמצאת בשימוש כמעט בכל העסקים והארגונים הבינוניים והגדולים בעולם, אך גם בשימוש של חברות קטנות Read More >>>

    More articles for you

    You are invited to contact us