Get Pca Application Form

The PCA application form is a critical document for notifying the Competent Authority regarding clinical investigations. This guide will provide you with step-by-step instructions to assist you in completing the form accurately and efficiently in an online format.

Follow the steps to complete the PCA application form online.

1. Click 'Get Form' button to obtain the PCA application form and open it in the designated editor.
2. Begin by entering the date the documentation will be sent to the Competent Authority. Fill in the day, month, and year in the provided fields.
3. Indicate whether this is a first submission or a resubmission by selecting the appropriate checkbox.
4. If this is part of a multi-centre clinical investigation, provide details of other countries that will be or have been approached.
5. Complete the declaration section by ensuring it is signed by the manufacturer’s duly authorized signatory. Include the manufacturer’s name, their full name printed, and sign the declaration.
6. Fill out the manufacturer information section by entering the full name, postal address, telephone number, and fax number of the manufacturer.
7. If applicable, enter details for the manufacturer’s authorized representative including their name, address, telephone number, and fax number.
8. In the device information section, provide the manufacturer’s trade name, notified body reference number, and details of certification related to the clinical investigation device.
9. Fill in the total number of devices in the UK clinical trial and the commencement and completion dates for the clinical investigation.
10. Include the contact information for the person responsible for this application, ensuring to provide their full name, address, and contact numbers.
11. Complete the checklist at the end of the form by confirming that all required information and documentation is enclosed.
12. Once all sections of the form are completed and verified, proceed to save your changes. You will have options to download, print, or share the completed form.

Complete your PCA application form online today to ensure timely submission.