Declaration of Foreign Manufacturer (To be issued on company letterhead) To: The Ministry of Health, the Department of Medical Devices, Sheba Medical Center, Bldg. 130, Tel-Hashomer 52621, Israel Name of Device: Name of Manufacturer: Address of Manufacturer: Telephone Number: Name and Manufacturing Site: Address Telephone Number: Name of Agent in israel Address of Agent: Telephone Number: 1) We hereby certify that: 1.1All the documents for registration of the above-mentioned medical device are valid at the date of submission; 1.2The medical device has not been subject to any disciplinary regulatory action (e.g., warning letter, recall) by any Competent Authority, by the date of submission for registration in Israel; 1.3The medical device exported to Israel, is identical to the device as approved and marketed in one of the following countries: Australia, Canada, European Community, Japan, U.S.A. 2) We hereby undertake: 2.1To report to the Ministry of Health any malfunction or adverse reaction pertaining to the use of the device, which is brought to our attention; 2.2To report to the Ministry of Health on any change in the regulatory status of the device (e.g., change of manufacturer, change of Manufacturing site). Name of signatory: __________________ Title: _____________ Signature: _________________________ Stamp of the manufacturer: Date: ______________
