What Are The Steps To Obtain A Medical Device License In Taiwan?

To obtain a medical device license in Taiwan, you must first determine the device classification based on its risk level. Next, prepare the required documentation, including safety, efficacy, and quality data. Submit a pre-market application to the TFDA, which will conduct a thorough technical review and inspections. If the device meets all regulatory standards, the TFDA will grant approval and issue the license.

Leave a Reply

You must be logged in to post a comment.