Get Field Safety Corrective Action Form Type Of

Completing the FIELD SAFETY CORRECTIVE ACTION FORM Type Of is essential for ensuring the safety and compliance of medical devices. This guide provides clear and detailed instructions to help you navigate each section of the form effectively.

Follow the steps to fill out the FIELD SAFETY CORRECTIVE ACTION FORM Type Of online

1. Click the ‘Get Form’ button to obtain the form and open it in your preferred editing tool.
2. Indicate the type of report you are submitting by selecting from 'Initial', 'Follow up', or 'Final' on the form.
3. Identify the Type of Field Safety Corrective Action (FSCA) by selecting one of the options such as product recall, device exchange, or device modification.
4. Provide the particulars of the submitter by entering the manufacturer's or importer's details including company name, address, contact person's name, position, phone number, fax number, email address, and registration number.
5. Fill in the device details by entering the common name, brand name, intended use, regulatory status, model number, serial number or lot/batch number, catalogue number, software version, and any affected accessories.
6. Complete the FSCA information section by specifying the reason for the FSCA, conducting a risk evaluation, and outlining the FSCA strategy.
7. Enter the dates and expected dates of action for the FSCA, including communications sent to consignees within Thailand and other countries.
8. Provide the number of affected medical devices, including those sold, distributed, remaining, and expected to be imported.
9. Submit the final report sections, including the completion date of the FSCA, effectiveness checks, final risk evaluation, and product status details.
10. Confirm the actions taken on affected products, including returning, destroying, or other approved actions, and provide a signature, name of the reporting person, date, and company stamp.
11. Once all fields are completed accurately, you can save changes, download, print, or share the form as needed.

Begin the process of completing your FIELD SAFETY CORRECTIVE ACTION FORM online today.