Table 1.

Agencies involved in the regulation and reimbursement of medical technology.

Country	Main regulatory agency	Reimbursement/HTA agency
USA	The FDA is responsible for approving new DTx within the software-as-a-medical-device category.	Depends on the classification of the device and the level of coverage requested (Medicare, Medicare Advantage, Medicaid, the Department of Defense)
Germany	The Federal Institute for Drugs and Medical Devices (BfArM) and The German Institute of Medical Documentation and Information (DIMDI)	Institute for the Hospital Remuneration System (InEK)
France	National Agency for the safety of Medicines and Health Products (ANSM)	National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS)
United Kingdom	Medicines and Healthcare products Regulatory Agency (MHRA)	National Institute for Health and Care Excellence (NICE); local commissioning groups (CCGs)
Australia	Therapeutic Goods Administration (TGA) for medical devices	The Medical Services Advisory Committee makes recommendations on inclusions in Medical Benefits Schedule (MBS)