Regulations on Unique Device Identification Management, Etc.

Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices

ENFORCEMENT RULE OF THE MEDICAL DEVICES ACT_Ordinance of the Prime Minister No.1819_20220721 의료기기법 시행규칙(2022.7.21.) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding and have no legal effec...

Regulation on the Permission, Notification, Review, Etc. of Medical Devices(No. 2022-52, July 29, 2022) 의료기기 허가/신고/심사 등에 관한 규정(2022.7.29.) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding ...

ENFORCEMENT RULE OF THE ACT ON IN VITRO DIAGNOSTIC MEDICAL DEVICES(20201231) 체외진단의료기기법 시행규칙(20201231) Note: MFDS offers the English version as a service to an international audience. Any discrepancies or differences created in the translation are not binding and have no legal effect for complian...

Instructions on Labeling and Management of Unique Device Identifiers

Regulations on Labeling and Description of Medical Devices

Standards of Medical Device Good Manufacturing Practices_Revised

This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyze medical...

This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS) an...