Get Manufactures Report Format 2020-2025

Filling out the Manufactures Report Format accurately is essential for proper reporting and compliance in the medical devices vigilance system. This guide provides a step-by-step approach to ensure all necessary information is captured effectively.

Follow the steps to complete the form with ease.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Begin with the administrative information. Specify the national competent authority (NCA) to which the report is being sent from the list provided. Select the type of report: initial, follow-up, or final. Enter the date of the report, the reference number assigned by the manufacturer, and other applicable identifiers.
3. Fill in the information about the submitter of the report. Indicate the status of the submitter as either a manufacturer, authorized representative, or other role, providing necessary details for identification.
4. Provide comprehensive manufacturer information including name, contact name, address, postcode, phone number, email, city, fax, and country.
5. Enter authorized representative information as applicable, including name, contact name, address, postcode, city, phone, fax, email, and country.
6. Complete the national contact point information with the contact person’s name, address, postcode, city, phone, fax, email, and country.
7. Document detailed medical device information. Include the class of the device, nomenclature system, commercial name, model number, serial numbers, lot/batch numbers, manufacturing dates, expiry dates, catalogue numbers, and notified body ID-number if available.
8. Describe the field safety corrective actions (FSCA) in detail. Include the background information and justification for the FSCA, along with advice for distributors and users regarding actions they should take.
9. Conclude with the comments section if needed. Ensure to provide a signature, name, city, and date at the end of the report affirming that the information is correct to the best of your knowledge.
10. After completing all sections, make sure to review your entries for accuracy. Users can then save changes, download, print, or share the form as necessary.

Start completing your Manufactures Report Format online today to ensure compliance and accurate reporting.