Get Fsca Report Form - Terviseamet.ee

Filling out the FSCA Report Form is an essential step in ensuring compliance with safety regulations regarding medical devices. This guide provides clear, step-by-step instructions to assist you in completing the form online accurately and efficiently.

Follow the steps to complete the FSCA Report Form online.

1. Press the ‘Get Form’ button to access the FSCA Report Form and open it in your editor.
2. In the Administrative information section, indicate which National Competent Authorities (NCA) the report is being submitted to. Select the type of report: Initial report, Follow-up report, or Final report. Provide the date of the report and enter the reference number assigned by the manufacturer.
3. In the Information on submitter of the report section, indicate your status as either Manufacturer, Authorised Representative within EEA and Switzerland, or Others, and specify your role.
4. Under Manufacturer information, fill in the manufacturer’s details, including the name, contact name, address, postcode, city, phone number, fax number, email, and country.
5. Complete the Authorised Representative Information with the authorized representative's details. Ensure all fields are accurately filled, including name, contact name, address, and email.
6. In the National contact point information section, provide the name of the national contact point, contact person, address, phone number, email, and country.
7. In the Medical device information section, select the classification of the medical device and fill in the nomenclature codes and descriptors. Include the commercial name, model number, serial number, and lot/batch numbers as applicable.
8. Describe the FSCA in detail, including background information and reasons for the corrective action, the severity of the issue, and the actions being undertaken. Also, advise on actions to be taken by the distributor and users.
9. Complete any additional fields as required for comments or submissions, ensuring accuracy in all provided information.
10. Finally, review your completed form for accuracy, and proceed to save your changes. You may then choose to download, print, or share the form as needed.

To ensure compliance and safety, complete your FSCA Report Form online today.