South Korea - Top Medical Device Alerts

Ministry of Food and Drug Safety (MFDS) extend the application scope of cybersecurity to any cases of license variations for legacy medical devices MFDS held a cybersecurity conference and introduced the cybersecurity review required for legacy medical devices regarding the latest regulatory compliance. Thus, the applicants must submit cybersecurity documents if any license variations are submitted for legacy medical devices, even though the change is irrelevant to cybersecurity.

Ministry of Food and Drug Safety (MFDS) announced the definitions of Software in Medical Devices and implemented new criteria of license variation for software upgrade The regulation is to define software developed/manufactured for the purposes specified in Article 2 of the Medical Device Act as 'medical device software' and classify software depending on the type of use and purpose, 'embedded Software,' 'Standalone Software,' 'Mobile Medical App,' etc. In addition, changes corresponding to software upgrades, such as changes in main functions related to the purpose of use, analysis algorithm (analysis method), development language, operating environment, or communication function, require approval/certification for change. For other changes, it requires the license holder to directly write the details and date of change on the back of the license and report (30 days or annually) to the Minister of Food and Drug Safety.

Extended the application scope of UDI Database registration to Class 1 MD The UDI registration was introduced in June 2019. It has been implemented with different timelines depending on classes. As of July 2022, manufacturers/importers for Class 1 MD require registration of UDI to the database (https://udiportal.mfds.go.kr/).

Extended the application scope of Monthly Supply History Reporting to Class 2 MD The requirement of reporting monthly supply history was introduced in October 2019. It has been implemented with different timelines depending on classes. As of July 2022, manufacturers/importers for Class 2 MD require Monthly Supply History Reporting to the database (https://udiportal.mfds.go.kr/).

Extended the application scope of Usability in GMP to Class 1 MD The Usability requirements in GMP were introduced in March 2019. It has been implemented with different timelines depending on classes. As of July 2022, manufacturers/importers for Class 1 MD require meeting the usability requirements in their QMS.