The process of Medical Device registration and submission in Israel
In Israel, the regulatory body that is responsible for Medical Device submission, registration, supervision and control over the manufacture, assembly, sterilization, import, and marketing of medical devices is the Medical Device Division of the Israeli Ministry of Health (“AMAR”).
The Israeli Medical Device Division deals with granting various types of import permits for medical devices, with monitoring the marketing process of the medical devices and with the publishing of documents, guidelines and procedures that assist in the import process of medical devices that is being manufactured aboard and imported to Israel.
The Medical Device Division in the IMOH is the unit concerned with the licensing and supervision process for all kinds of medical devices, including rehabilitation, implants, measuring & monitoring devices, drug injection devices, software, cellular Apps, mobility devices and combination products (in case included in the second amendment of the medical devices law). The Medical Device Division of the Israeli Ministry of Health (“AMAR”) deals with everything, from granting permission for registration in the registry of medical devices, export and import permits for manufacturers and importers.
Israel does not have its own medical device “classification” but recognizes the classification from the following authorities, and in addition, the company will need to demonstrate approval from one of the GHTF country:
- FDA 510(k)
- CE Marking certificate issued by a European Authorized Body
- Certificate to Foreign Government (CFG) or Certificate of Free Sale (CFS)
Concerning companies who have already obtained approval for their devices in one of these markets (particularly Europe and the US), registration is relatively “straight forward”.
If the device is not registered in one of the GHTF countries, you will need to show the following documents to “AMAR” department:
- Risk Analysis
- Clinical evaluation
- Clinical trial data
- Expert opinion
What is The Israeli Registration Holder (IRH)?
According to the Israel’s Medical Devices law, the Israeli registration owner has to be an Israeli agent of the manufacturer/rights owner that is located outside Israel.
The registration procedure must be carried out through 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”.
IRH responsibilities and requirements for Medical Device import to Israel
- Reside and maintain a place of business in Israel.
- Business license
- ISO 9001:2015 certification
- Prepare and submit the registration application to AMAR.
- Review and approve the first batch of devices to be marketed in Israel as requested by AMAR
- Provide professional support and clarifications to any questions from AMAR concerning the registered product
- Report adverse events to AMAR.
- Renew the registration on time to keep the market approval active and to assure a continues supply of devices to the market
- Receive documents on behalf of the legal manufacturer and send to submit it to AMAR
- Review, assess and report with post marketing requirements, including:
- Evaluate information provided by physicians, patients and costumers
- Forward the information to the medical device manufacturer
- Prepare periodical post marketing 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
Additional requirements for Medical Device registration in Israel
Some electro-medical 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 in case they are in English. In the case the medical device is intended for domestic use, the labeling and instructions for use must be provided in English, Hebrew and Arabic. In the case the device is intended for professional use only within health facilities, the labeling and instructions for use may only be 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.