Korea, Republic of | Proposed partial amendments to the Regulations on Standard Specification of Medical Devices

The Republic of Korea has proposed partial amendments to the Regulations on Standard Specification of Medical Devices in order to ensure product safety and performance. The proposed amendments include the establishment of new standards and specifications for 7 types of medical devices, such as high-intensity focused Ultrasonic surgical systems and mammographic x-ray systems. The amendments also aim to align with international standards, including IEC and ISO, for 23 types of medical devices, such as anaesthesia systems and infant incubators. The objective of these changes is to protect human health and safety.

Documents

• Link to Partial revision of medical device standards (draft) in korean
• Link to Partial revision of medical device standards (draft) - automated english translation)