South Korea - Proposed Partial Amendments to the Regulations on Standard Specification of Medical Devices

​The proposed amendments to the Regulations on Standard Specification of Medical Devices are as follows:

1) Establishment of Medical Device Standards

- Establishment of new standards and specifications to ensure product safety and performance of 7 types of medical devices, including high-intensity focused Ultrasonic surgical systems and mammographic x-ray systems (stationary, analogue).

2) Align With International Standards

- Ensuring product performance and safety by applying the international standards (IEC, ISO) of test criteria and methods to 23 types of medical devices, including an aesthesia systems (gas) and incubators (infant).