A medical device may be designated as an Innovative Medical Device if it has an innovative feature in the technology, indications of use, or performance specifications that have no equivalence in the market. Furthermore, it is in the best interest of the patients, and at least one of the following criteria is met:
• the device provides considerable clinical advantages over an existing SFDA approved technology; OR
• the device provides considerable clinical advantages over an existing approved alternative treatment; OR
• there are no SFDA approved alternative technologies nor treatments available to patients
