Innovative Medical Device Designation Criteria

This section outlines the eligibility for a medical device to be classified as an innovative medical device according to the following criteria:

  1. The device should demonstrate novel technology or a significant improvement in design, effectiveness, or efficiency compared to existing devices, including but not limited to the application of AI, additive manufacturing (e.g., 3D printing), or other advanced technologies, and shall be supported, where applicable, by a valid patent or documented intellectual property;
  2. The proposed device should fall within Technology Readiness Level (TRL) 3 to 9, indicating progression from proof-of-concept to system validation and readiness for deployment; and
  3. The innovative medical device should have a well-established proof of concept.

Note 1: TRL 3 refers to Proof of Concept (POC), where the device has undergone basic testing to verify that the concept works in a controlled environment.

Note 2: TRL 4 to TRL 6 involve the development and testing of prototypes, while TRL 7 to TRL 9 represent stages where the device is ready for market use or is already operational in the field.