Do you have to use pharmaceutical excipients for medical device registration?
Must. The application for medical device registration usually requires the submission of information about the product, and the use of pharmaceutical excipients depends on the specific design of the product. If a medical device requires the use of a pharmaceutical excipient, then the use of the corresponding pharmaceutical excipient needs to be declared and approved when applying for registration. Some medical devices that require pharmaceutical excipients to enhance therapeutic efficacy, such as catheters, syringes, and other devices, often require the use of pharmaceutical excipients.