医疗器械行业-加拿大销售产品召回程序.doc

1. Purpose Establish the recall procedure to meet the requirement of Canadian Medical Device Regulation, to guide the development of the recall strategy, and to guide the implementation of recall. 2. Scope To removal or correction of products that violate the requirements of the Food and Drugs Act and the Medical Devices Regulations and that may represent a health hazard to the consumer or user. The recall may include the physical retrieval of the device from users, as well as any form of retrofit or correction made at user institutions, including labeling or instructional changes and user advisories. 3. Responsibility 3.1 Responsibility of Manufacturer 3.1.1 Management Representative is responsible for establishing the recall procedure. 3.1.2 International market department designs the recall strategy and implement the recall. 3.1.3 Technical Regulation department monitors the recall implementation. 3.2 Responsibility of importer The importer should establish the recall procedure and implement the recall of the products sold in Canada. 4. Definitions The following key terms are found within this procedure. The definitions listed below are the same as those given in the Medical Devices Regulations(Canada): RECALL in respect of a medical device that has been sold, means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness after becoming aware that the device (a) may be hazardous to health; (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or (c) may not meet the requirements of the Food and Drugs Act or the Medical Devices Regulations. RECALL STRATEGY means a planned course of action for conducting a specific recall. The strategy addresses matters such as the depth of the recall, recall communications and the need for public n