1、AGREEMENTPARTY A:NAME: ADDRESS: TEL: FAX: PARTY B:NAME: ADDRESS: TEL: FAX: PARTY A hereby appoints Party B as the authorized delegate of European Community and Party B accepts the appointment to be the authorized delegate of European Community for Party A in the market of European Communities. Both
2、parties enter this Agreement as follows:PARTY A1. Party A assures to provide the updated technical files of each category to Party B. 2. If there are any changes of products, Party A shall notify Party B at once. 3. If the serious accident of product is happened within boundary of EC, Party A shall
3、investigate the reason together with Party B, and complete the initial report and final report, Party A shall present these report to Party B, within regular time and report to competent authority. If the accident of products is happened out of E.C. Party A shall notify Party B, and make decision th
4、at whether report to competent authority or not. 4. Party A shall be responsible for any business dispute such as claim for compensation caused by medical accidents after Part in handing the disputes in accordance with the authorization of Part A. All the expenses happened during Party B handing of
5、the accident occurrence shall be borne Party A. PARTY B1. Party B shall responsible for registering Party A s products with CE mark with relevant competent authority of the country to which Party B is located.2. Party B shall reserve technical files of each category of Party A s products with CE mar
6、k. The technical files are reserved at least five years after manufacturing the products of last batch. 3. Party B shall notify any information about products with CE mark within boundary of E.C. including claim of customer.4. If the serious accident of product is happened within boundary of E.C., P
7、arty B shall notify a immediately and assist Party A to handle vigilance system of medical device products, and also report initial report, investigation result and final report to competent authority of country in which the accident is happened. This contract will be terminated automatically if the CE certification of Part A being withdrawn by the Notified Body during the implementation of the contract. Party A: Party B:Signature: Signature:Date: Date:2/2
