The Ministry of Food and Drug Safety (MFDS) will hold a meeting with relevant organizations and groups on March 18th, as the legal management system for digital medical and health support devices has been established with the enactment of the Digital Medical Products Act, ahead of its implementation next year.
This meeting will share domestic and international regulatory and industry trends and discuss the scope of digital medical and health support devices, self-reporting and self-performance certification plans, and distribution management.
The Digital Medical Products Act defines the concept of digital medical and health support devices in the law, introduces self-reporting and self-performance certification systems, and allows the MFDS Commissioner to manage products with false or exaggerated advertisements to support consumer protection and industrial development.
- Digital Medical Device: A medical device or in vitro diagnostic medical device that incorporates digital technology.
- Digital Combination Drug: A drug combined with a digital medical device or a digital medical and health support device.
- Digital Medical and Health Support Device: A device, machine, apparatus, or software that is not classified as a digital medical device, but is used for the purpose of supporting medical care or maintaining and improving health by monitoring, measuring, collecting, and analyzing biosignals, or by recording and analyzing lifestyle habits to provide health management information such as diet and exercise.
If you have any questions about Korean medical device certification, please feel free to contact GCA KOREA. Our experts will provide you with prompt and accurate guidance on the certification and approval process.
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