Updated: 9/26/2000.

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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 Israeli 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), or Pre-Market Approval (PMA). Biological devices fall under medical device classification and require FDA's Center of Biologics certificate. In most cases CE and Canadian documentation are also acceptable by IMOH.

If a product is approved by the U.S. FDA, it will be registered by the MOH with no further testing. However, electromedical devices must be tested at the Standard Institute of Israel (SII) for compliance with the Israeli system. The SII does not accept certifications from other countries.

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 (MSs), Japan, or the United States of America. If such certificate is not available, the registration process is still available but will take longer, between two to six months and MOH will determine what type of testing is needed. Product registration supported by an existing FDA documentation usually takes approximately four to six weeks.

The application for registration of a medical device shall be submitted to the Department of Medical Devices at the Ministry of Health. 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 on the date or renovation
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 (MSs), Israel, Japan, USA
Information on any risk which may be associated with the use of the device (including precautionary measures to be taken)
Instructions 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
Declaration, as appropriate: of the local manufacturer/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. Catalog registration is, for example, on an EKG device with different channels and accessories. Registration fees are updated by the MOH twice a year.

Medical devices are classified according to FDA guidelines.

Standards

The Standard Institute of Israel (SII) is the agency responsible for the development of most product standards, compliance testing, and certification of products and industry quality assurance system. Israel has stated its intention to follow international standards whenever possible. However, it has been reported that some standards still exist that tend to favor domestic producers over foreign manufacturers. Medical devices must comply with Israel's electric standard of 220 V, 50 Hz.

Labeling

Medical devices must have Hebrew labeling stating country of origin, name and address or the manufacturer, name and address of the Israeli importer. Biological materials should be labeled in addition with their content, weight, and volume in metric units.

Implantable medical devices require mandatory labeling in the patient's file. The labels must contain the following information:

Name and address of the manufacturer
Name and address of the importer
Type of implant
Sub-type of implant
Size
Serial number
Batch number
Reused implant
Medication element needed
U.S. Israel Free Trade Agreement & Customs Evaluation

Under the U.S.-Israel Free Trade Area Agreement (FTAA), American goods face no import duties upon entering Israel's market. However, products are still subject to Value-Added-Taxes (VAT), and purchasing taxes. In order to benefit from the FTAA, products must have a U.S. Certificate of Origin for Exporting to Israel (CO). VAT is levied on the CIF landed cost plus uplift (if applicable) plus purchase tax (added to some products, primarily luxury and consumer items).

Contacts

Ministry of Health
Medical Technologies & Infrastructure Administration
Medical Device Department
P.O. Box 1176
Jerusalem, Israel 91010
Contact person: Ms. Elona Bitnun, Coordinator
Phone: 972-2-5681354, 972-2-5681216
Fax: 972-2-6725827
E-mail: elona.bitnun@moh.health.gov.il

Ministry of Health
Medical Technologies & Infrastructure Administration
Medical Device Department, Tel Aviv Branch
Sheba Medical Center, Bldg. 130
Tel Hashomer, Israel 52621
Contact person: Mr. Nadav Sheffer, Acting Director
Phone: 972-3-5303291
Fax: 972-3-5344552
E-mail: sheffer@eng.tau.ac.il

Standards Institution of Israel
42 Haim Lebanon Street
Tel Aviv, Israel 69977
Contact person: Mr. Steli Loznen, medical device expert
Phone: 972-3-6467804
Fax: 972-3-6467779
E-mail: sloznen@sii.org.il
Web site: www.sii.org.il