The Israeli parliament, the Knesset, passed a new law in May 2012 regulating the registration of medical devices. The new law is expected to be implemented gradually in the next few years. The law was approved nearly a decade since it was first proposed. Under this legislation, all medical devices manufactured or marketed in Israel must be registered with the Ministry of Health registrar (AMAR – The Medical Device Division of the Israeli Ministry of Health) who is responsible for registering and supervising medical devices in Israel.
Before the law was published only medical devices supplied to governmental medical institutions had to be registered by the AMAR division. All other devices could be registered voluntarily. The AMAR registration is held in high status, therefore many manufacturers decide to register their devices even they were not required to do so.
The new medical device law number 5772-2012
According to the new Law, medical devices manufactured or marketed in Israel shall be registered by the Ministry of Health registrar (AMAR – The Medical Device Division of the Israeli Ministry of Health).
Registration of medical devices in Israel is based on approvals in one of following countries: Australia, Canada, European Union, Island, Norway, New-Zealand, Switzerland, Japan, or the United States.
The Medical Equipment Law imposes a criminal prohibition for manufacturing, importing, marketing and using medical equipment which has not been registered in the AMAR, except in exceptional cases and with the approval of the Israeli Ministry of Health.
The Israeli medical device industry continues intense growth
Israel is one of the world’s leading centers for the development of innovative medical devices. The country has by far the highest proportion of any country of new patents in this sector per caita. There are nearly 800 companies in this field, which consists of about half of the life sciences sector.
Israel’s strength in this sector come from multidisciplinary capabilities, which bring together medicine, engineering, clinical expertise and software. Some of the world’s leading universities with renowned R&D faculties, leading edge medical centers, the world’s highest per-capita number of physicians, and a remarkable high-tech sector combined with a spirit of entrepreneurship have all contributed to the dynamic growth in medical devices.
In recent years Israel’s medical device sector is attracting increasing amounts of foreign investment. This is achieved through VC funds, IPOs and direct investments from major US and international companies such as: Johnson & Johnson, Boston Scientific, Medtronic and Guidant.
The Israeli Registration Holder (IRH)
According to the new Law, medical devices manufactured or marketed in Israel shall be registered by the Ministry of Health registrar (AMAR – The Medical Device Division of the Israeli Ministry of Health). Applications for registration shall be done only by an Israeli citizen or by a corporate established in Israel.
According to section 3(d), the submission to AMAR can be done through a professional and skilled third party.
The Israeli Registration Holder (IRH) is responsible for the following activities:
- Reside and maintain a place of business in Israel and serve as the regulatory representative (ref. section 3(b)).
- Prepare and submit the registration application to the AMAR Division (ref. section 3(b)).
- Review the first batch of devices to be marketed in Israel as requested by the Amar Division (ref. section 7(a)1).
- Respond to questions from the AMAR Division concerning the registered products (ref. section 15(b)).
- Report any adverse events to the AMAR Division (ref. section 15(b)).
- Renew the registration on time to maintain the market approval active (ref. section 8).
- Receive documents from the AMAR Division on behalf of the legal manufacturer and liaise with the registrar (ref. sections 9(b) and 12).
- Perform Post Marketing activities, including evaluation of information provided by users and forward it to the legal manufacturer, prepare periodical reports (upon request), report of adverse and unexpected incidents occurred in Israel or other countries where the device is in use, report of restrictions from other regulatory bodies concerning the registered devices (ref. section 11).
Why select an independent Israeli Registration Holder (IRH)?
The distributor of a medical device may act as the regulatory representative in Israel. However, there are several reasons why it may be advantageous to select an independent professional Israeli Registration Holder (IRH):
- The independent professional has extensive experience and know-how in Regulatory Affairs and with the Israeli regulations in particular.
- The independent IRH deals only with regulatory issues with no commercial interest in the product.
- To avoid potential problems associated with switching distributors if a poorly performing distributor is also the IRH.
- Competitive problems if one distributor acts as the IRH and the legal manufacturer wish to appoint a second distributor, or the distributor represents different legal manufacturers with competitive products.
- Having to entrust the distributor with the proprietary product design information.
- Dealing with conflicts of interest with the distributor in the event of a product recall or incident report to AMAR.
- Having to rely on the distributor for regulatory updates in Israel.
MedicSense can act as your In-Country Israeli Registration Holder (IRH), we can also assist you in choosing a local importer/distributor.