Calculations, Verifications and Certification of TKDN for Medical Devices and In-Vitro Diagnostic Medical Devices Regulated by the Minister of Industry

In an effort to support the development of the domestic medical device industry and in-vitro diagnostic medical device industry and thereby enhance current levels of public health protection, the Minister of Industry (“ Minister ”) has issued Regulation No. 31 of 2022 on Provisions and Procedures for Calculations of Domestic Component Level Values for Medical Devices and In-Vitro Diagnostic Medical Devices (“ Regulation 31/2022 ”). [1]