医疗器械行业-加拿大销售产品事故报告程序.doc

1. Purpose Establish the Canadian Reporting Procedure to meet the requirement of Canadian Medical Devices Regulation and Food and Drug Act, and to guide the Mandatory problem reporting and voluntary reporting. 2. Scope Any incident that comes to Minister’s attention occurring inside or outside Canada and involving a device that is sold in Canada and that is pertaining to Mandatory report or voluntary report. 3. Responsibility 3.1 Responsibility of Manufacturer 3.1.1 Management Representative establishes the Canadian Problem Reporting Procedure. 3.1.2 International Market Department collects the information about the problem reporting. 3.1.3 Technical Regulation Department monitors the implement of the problem reporting. 3.2 Responsibility of Importer The importer should establish and implement the relevant procedure on problem reporting procedures. 4. Definitions The following key terms are found within this procedure: Serious deterioration in the state of health means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage 5. Procedure 5.1 Management Representative is responsible to organize a meeting to analysis of all the information from importer, patients, users, and so on, including any complaint, if any incident that comes to the attention of the Minister of Health Canada occurring inside or out side Canada and involving a device that is sold in Canada and that: (a) is related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its the directions for use; and (b) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur. Then the problem report is necess