Bio News
Based on more than 1,000 cases, the Ministry of Food and Drug Safety clarified the criteria for exempting digital medical devices, including medical artificial intelligence (AI), from clinical trials. Accordingly, seven types of devices eligible for approval based solely on performance verification have been identified, and the special-case period for the good management system will be extended from 1 year to up to 3 years. The revision is intended to reduce unnecessary clinical trials and promote the development of the latest AI products.
BIOBOOK TEAM
biobookmedia@biobook.co.krRural Development Administration Develops Two Molecular Markers to Identify Leaf Splitting in Squash
MFDS Begins Distribution of Internationally Certified Reference Materials, Including 24 New Items, for a Total of 882
Ministry of Trade, Industry and Energy signs agreement to promote biotech and medical devices in Gangwon; site visit set for the 14th
RDA develops technology to produce anti-inflammatory exosomes for pets and files patent application
HLB Submits FDA Resubmission for First-Line Liver Cancer Treatment
Celltrion Reports Third-Quarter Revenue of 1.5 Trillion Won and Operating Profit of 510 Billion Won, Up 69% Year Over Year
Rural Development Administration Develops Two Molecular Markers to Identify Leaf Splitting in Squash
MFDS Begins Distribution of Internationally Certified Reference Materials, Including 24 New Items, for a Total of 882
Ministry of Trade, Industry and Energy signs agreement to promote biotech and medical devices in Gangwon; site visit set for the 14th
