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Get Gn-24-r1.1 Guidance On The Change Of Registrant
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How to use or fill out the GN-24-R1.1 Guidance On The Change Of Registrant online
This guide provides clear, step-by-step instructions on filling out the GN-24-R1.1 form for the change of registrant of a registered medical device. It aims to support users at all levels of experience in completing the forms accurately online.
Follow the steps to fill out the GN-24-R1.1 form effectively.
- Use the ‘Get Form’ button to access the GN-24-R1.1 form and open it in the appropriate editor.
- Complete the Accepting Company section with the name, address, and contact information (telephone, fax, and email) of the newly appointed Registrant.
- Provide a duly completed and signed Change of Registrant Application Form, ensuring it includes all required information.
- Prepare the letter of authorization from the Product Owner on company letterhead, appointing the Accepting Company as the Registrant.
- Draft a letter from the Product Owner to HSA, including the effective date of the appointment, the list of applicable registered medical devices, and any necessary changes to the registered medical devices.
- Complete the Relinquishing Company Declaration Form, ensuring it is signed by a company director or senior officer.
- Review all provided information for accuracy, attach any additional documentation if necessary, and ensure signatures are included where required.
- Submit the completed form and all supporting documents via email or fax to the specified contact information.
- Upon submission, wait for the notification of the outcome from HSA regarding the application for the change of Registrant.
Complete your documents online today for a smooth transition of registrant!
There are 3 classes of medical devices: Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. Class II devices are intermediate-risk devices. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications.
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