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MEDICAL DEVICES License AMENDMENT FATBACK FORM GUIDANCE FOR INSIGNIFICANT ADDITIONS/DELETIONSPLEASE READ CAREFULLY Please note that in order to add a catalog number the device must already exist on
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A medical devices licence amendment is a modification or update made to an existing licence for medical devices to reflect changes in the device, its intended use, or manufacturing process.
Manufacturers, importers, and distributors of medical devices are required to file a licence amendment when there are changes to the device that may affect its safety or effectiveness.
To fill out a medical devices licence amendment, the licensee must provide detailed information about the changes to the device, its intended use, and manufacturing process. This information must be submitted to the relevant regulatory authority.
The purpose of a medical devices licence amendment is to ensure that the device remains safe and effective for its intended use. It allows regulatory authorities to review any changes that may impact the device's performance.
Information that must be reported on a medical devices licence amendment includes details of the changes made to the device, supporting data for the changes, and any potential impact on the device's safety and effectiveness.
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