The Oyamo group obtained the import license from the Israel Ministry of Health which permitted the shipment and initiated the purchase order. The CTLM system will be placed in the prestigious hospital Hadassah, located in the heart of Jerusalem. The Hadassah University Medical Center is a tertiary care referral facility, known for pioneering new medical techniques.
azooptics.com
Ministry of Health
2 Ben-Tabai St.
P.O. Box 1176, 91010 Jerusalem
Tel. (02) 6705705
Fax. (02) 6233026
Website: health.gov.il
E-mail: revital@matat.health.gov.il
(Source: Israel Government Year Book)
mfa.gov.il
In Israel, a system of administrative requirements and restrictions on imports is still being imposed. These restrictions are referred to as non-tariff barriers and are mainly implemented in the following ways:
Import License - Import licenses are presently required for some of the goods imported to Israel. The competent authority to grant import licenses is in most cases the Ministry of Industry & Trade.
chamber.org.il
Medical Device Regulatory Requirements for Israel
Disclaimer: The information contained on this website is derived from public
sources and is current to the best of our knowledge. For detailed and definitive
information about a country's laws and policies, the government of the country
concerned should be consulted.
Israel Regulatory System
Ministry of Health (MOH) in Israel is the government agency charged with
meeting Israel’s health care needs and regulations. The MOH recognizes Food
and Drug Administration (FDA) certification and the European Union CE Mark,
and approves products carrying such certifications without further requirements.
Furthermore, MOH implements FDA’s recommended indications for the device.
MOH approval stipulates marketing authorization in the USA, and therefore
accepts 510K, PMA and export certificates such as the Certificate to Foreign
Government.
Registration
Medical devices, including biologics, must be registered with Israel’s Ministry
of Health (IMOH) before they can be sold in the country. Companies wishing
to export medical equipment or devices to Israel must have a local Israel agent
or distributor who should request a pre-marketing approval from the IMOH.
The request should be accompanied by one of the following documents: the
U.S. Food and Drug Administration (FDA) 510(k) marketing authorization, or
Pre-Market Approval (PMA). Biological devices fall under medical device
classification and require FDA’s Center of Biologics Certificate. In most cases
CE Mark (European Union) and Canadian documentation are also accepted by
IMOH.
For any imported medical device the Israeli importer/agent must submit a
registration application to MOH Department of Medical Devices. The
application should include (if available) a certificate issued by a competent
authority of one of the following countries: Australia, Canada, European
Community (CE) Member States, Japan, or United States of America. If such a
certificate is not available, the registration process is still available but will take
a longer time, and MOH will determine what type of testing is needed. Product
registration supported by an existing FDA documentation usually takes
approximately eight to twelve weeks.
The application for regulation of a medical device shall be submitted to the
Department of Medical Devices at the MOH. The application should be
submitted on the special form designated for this purpose and shall include the
following:
Name and address of the manufacturer, and of the importer as applicable,
Description of the intended use of the medical device and of its medical
indications,
Technical details of the medical device and of its components, and in the event
that the device or the components are not new, information should be provided
regarding renovation and the date,
Certificate attesting to the safety of the device, issued by a competent authority
of one of the following countries: Australia, Canada, European Community
(EC), Member States, Israel, Japan, and the United States of America,
Information on any risk which may be associated with the use of the device
(including precautionary measures to be taken),
Instruction for use of the device in Hebrew. The MOH may allow the
instructions to be in English for certain devices,
Details of the standards to which the device complies,
Description of the technical and maintenance services, including periodic checks
and inspections, and
Declaration, as appropriate of local manufacture/importer, and of the foreign
manufacturer.
Note: A license (marketing authorization) for a medical device, granted by the
MOH, is valid for five years from the date of registration of the device, except
for implants with a life –supporting function, for which the validity is for two
years from the date of registration.
In addition to the usual requirements for the registration of medical devices, as
applicable to the particular device, specific requirements exist for the products
detailed hereunder, which should be included in the application:
?Tissues, including corneas, for transplantation into human beings
? Medical devices containing components derived from animal origin
? Kits for diagnosis of HIV infection
? Coronary stents
Registration costs $222 per single item, and $1,112 per catalog registration.
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