RK-QP8.5-01医疗器械通告和撤回控制程序.doc

1.Purpose In the case of products events happening/or the serious results caused by a certain quality defects, issue notice and recall products,to prevent the similar events or the potential hurts recurrence,or to release the incidents affects or results. 2.Scope Applicable to issue notices, recalls and launching matters need attention of the products sold abroad. 3. Responsibility 3.1 The distributor is responsible for deliver clients complaints and events to the manufacturer, and saves the products sale records. 3.2 Manufacturer 3.2.1 Manager representative is responsible for: Report the notices and matters need attention, incidents report to the principle administration within the specified period. Analyse the information (from distributors/the sick or the user and scientific literature) and incidents; supervise and control the products notices issuing and recall; supervise the products recall progress and amount. 3.2.2 Marketing department is responsible for deliver the measures taken to distributor, and to the sick or the user if necessary. 3.2.3 The office is in charge of the effective control to documents. 4. Procedure 4.1 Manager representative is in charge of analysis of the relevant information and incidents of the products sold out, and confirm to take necessary measures according to the problem severity degree. The measures to be taken include: Products launching matters need attention; Issuing products notices; Recalling products; The disposal to the recalled products. Products launching matters need attention; 4.2.1 Through the relevant information analysis, for the issues that the products comply with the expected applications, but supply the unclear information, the manager representative is in charge of releasing the products matters need attention. 4.2.2 The marketing department shall advise the matters to distributors and users. Products notices; For the conditions is beneficial to improve the sold products utilization, prev