CE医疗器械警戒系统(英文版).docVIP

Co.Ltd. Ref : QP-001-024 Version: C0 Page(s) 1st of 7 The Medical Device Vigilance System Purpose The principal purpose of the Medical Device Vigilance System (Hereinafter referred as the ‘System’) is to improve the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of the incident elsewhere. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents. Scope The ‘System’ applies to incidents with regard to: ?2.1 devices which carry the CE-mark (Hereinafter short for ‘CE products’) within EU 2.2 devices that do not carry the CE-mark but where such incidents lead to responsibilities of corrective action(s), medical incident(s) and report(s) within EU relevant to ‘CE products’ mentioned above. 2.3 devices which carry the CE mark outside EU. 3．Responsibility 3.1 The Manufacturer’s Responsibilities: The Manufacturer shall start investigation once upon the incident notice is received, and find out the relationship among the responsible bodies, authorized EU representatives and their National Competent Authorities. 3.2 The Authorized EU Representatives’ Responsibilities: Once the incident notice is received, the authorized representatives within EU shall notify the Manufacturer immediately and assist him to deal with incidents, and meanwhile, submit to their National Competent Authorities the initial report, investigate outcome and the final report. 3.3 The Sellers or Distributors’ Responsibilities: The sellers or/and distributors shall report customers’ complaints and submit incident reports to the Manufacturer timely, and keep the sales records. 4．Procedure 4.1 The management representative shall decide items to be reported to the local competent authorities after an analysis of incident report details, and joint investigation by biochemical and quality con