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Old 07-23-2011, 17:37 PM   #1 (permalink)
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Default Israel Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices


General Market Condition: No Restrictions
Summary
The Israeli market for used medical equipment is very small and considered insignificant for US exports. There is no special tariff that applies, and the official import requirements are the same as for new equipment. However, in practice, the Ministry of Health (MOH) permits the import of used/refurbished equipment only by specific end-users, and does not issue registration certificates for imported used equipment.
The Registration Process
By law, all medical equipment used in public health institutions requires MOH Registration. MOH registration provides the health institution legal protection in the event of mal-function of the device. Hospitals and other health institutions may import or receive donated equipment if it is for their own use only. However, they will not receive the MOH “blessing” and they will operate the equipment at their own risk. MOH does not approve imports of used/refurbished equipment by commercial agencies/distributors for resell in the market.
Import Requirements
In order to release used medical equipment from customs, MOH requires the end-user to report in details the complete history of the device: by whom, for how long, and where the equipment was used and / or refurbished and where it was tested to comply with technical standards. The end-user must declare that the used equipment is for its own use and provide a proof of available chain of supply (of spare parts) from the original manufacturer.
Parallel Imports
If a manufacturer or its agent registered a medical device in Israel, a third party cannot relay on this registration to import the same device in used/refurbished condition without being subject to the above import requirements. The same applies to parallel imports of new equipment.
Type of Used/Refurbished Equipment already in the Market
Existing used or refurbished equipment in local hospitals include ultra-sound and laser.
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