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 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.
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