Get Canada Medical Device Recall Reporting Form - Initial 2016-2025

This guide provides essential, step-by-step instructions for completing the Canada Medical Device Recall Reporting Form - Initial online. This form is crucial for manufacturers and importers to report necessary information to Health Canada regarding medical device recalls in a timely manner.

Follow the steps to effectively fill out the reporting form.

1. Press the ‘Get Form’ button to acquire the form and open it in your preferred editing tool.
2. Identify the submitter type. Indicate whether you are acting as the manufacturer or an importer reporting on behalf of the manufacturer.
3. Complete section 64 (a) by providing the name of the device and its identifier. Include identifiers for any related devices if applicable.
4. In section 64 (b), provide the name and address of both the manufacturer and importer, along with the establishment address where the device was made, if different.
5. For section 64 (c), describe the reason for the recall, summarizing the defect or potential defect found, including the date of discovery.
6. Section 64 (d) requires an evaluation of the risk associated with the identified defect. Detail your findings and attach any relevant documents.
7. In section 64 (e), note the number of affected units, specifying how many units were manufactured, imported, and sold in Canada.
8. Complete section 64 (f) by indicating the period during which affected devices were distributed, specifying start and end dates.
9. In section 64 (g), list names and numbers of units sold to each consignee, or attach a separate list for convenience.
10. Provide any recall communication details in section 64 (h) and attach copies of communications if available.
11. For section 64 (i), outline the proposed strategy for carrying out the recall, including start date and proposed completion date.
12. Section 64 (j) asks for preventive measures to avoid recurrence of the defect, detailing ongoing investigations and corrective actions planned.
13. Complete section 64 (k) by entering the name, title, and contact number of the representative from the manufacturer or importer.
14. Review all sections for completeness and accuracy. Save your changes, and when ready, download, print, or share the completed form.

Ensure all documents are accurately completed and submitted online.