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1、1. PurposeEstablish 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. ScopeTo removal or correction of products that violate the requirements of the Food and Drugs Act and
2、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 adviso
3、ries.3. Responsibility3.1 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 impleme
4、ntation. 3.2 Responsibility of importer The importer should establish the recall procedure and implement the recall of the products sold in Canada. 4. DefinitionsThe following key terms are found within this procedure. The definitions listed below are the same as those given in the Medical Devices R
5、egulations(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
6、 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. REC
7、ALL 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 notice, the level of effectiveness checks and the control of returned stocks. RECALLING FIRM means the firm th
8、at initiates a recall. The firm usually bears primary responsibility for the manufacturing/importing and the marketing of the product being recalled. CONSIGNEE means anyone who has received, purchased or used the product being recalled.5. Procedure5.1 Recall strategy After deciding that a recall is
9、necessary, the international market department will design the recall strategy. The recall strategy is a detailed plan for implementing a firms recall procedure in a specific case. The strategy is based on the particular circumstances of the situation, including the following factors: 1)the hazard o
10、r risk the product represents (Priority I, II or III mentioned in complaint handling procedure); 2)the target population; 3)the ability of users to identify the product; 4)the obviousness of the products defect; 5)the number of the affected devices in the marketplace; 6)the anticipated shelf life of
11、 the product; and 7)the continued availability of essential products. Based on these factors, the recall strategy will address the following elements: 1)Depth of the Recall 2)Recall Communications 3)Effectiveness Checks4)Stock Control5.1.1 Depth of the Recall The users of the affected device should
12、be identified in order to determine the depth of the recall. Users may be hospitals, clinics and members of the medical profession or a subgroup of the medical profession.5.1.2 Recall Communications The recalling firm is responsible for promptly notifying each of its consignees (anyone who received
13、or purchased the affected device) about the recall. The format, content and extent of communication should be commensurate with the hazard of the product being recalled and the strategy developed for the recall. Recall communications should be brief and to the point and should not contain irrelevant
14、 qualifications, promotional material, or any element that may detract from the message. In general, recall communications should include the following: 1)Description of the product: The name, size, lot number(s), serial number or any other relevant descriptive information should be specified to ena
15、ble immediate and accurate identification of the product that is subject to recall.2)Hazard associated with the product: The reason for the recall should be concisely explained. It should be made clear that further distribution or use of the product should cease immediately. The consequences of usin
16、g the product in its affected state should be stated. 3)Instructions for recall of the product: Specific steps should be given for the return, disposal or correction of the affected product. 4)Instructions for notification of users: The recall communication must emphasize the consignees awareness of their responsibility to notifying any accounts that received the affected product. Consignees should immediately carry out the instructions set forth by th
