Proposed partial amendments to the Regulations on Standard Specification of Medical Devices; (5 page(s), in Korean)
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 anaesthesia systems (gas) and incubators (infant).