Regulations at Four hierarchical Orders · Overview of Notification, Certification and Approval Process in Medical Devices · Overview of Device Business License.

Risk-based classification Medical devices in South Korea are classified as Class 1, Class 2, Class 3 or Class 4 based on increasing risk. Per risk class the ...

Learn about South Korea's MFDS registration process per device classification, available for download in the Regulatory Affairs Management Suite (RAMS).

Medical device classification closely follows the Global Harmonization Task Force (GHTF) Classification guidelines, with Class I, II, III and IV designations ...

This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission)

Class I and some Class II devices require certification by the NIDS, while new Class II devices, Class III, and Class IV devices require approval by the MFDS.

The standards and procedures for the classification and designation of the class of each medical device under Article 3 (2) of the Medical Devices Act ( ...

For medical devices classified as Class II, Class III, and Class IV, including those with new types of technology or new intended uses, the MFDS requires ...

For Class III and IV medical devices the application has to be submitted to MFDS, Head Office, for product approval after technical document review by MFDS. In ...