Korea Medical Device Regulations Current Korea medical device regulations are covered under theMedical Device Act (MDA)that went into effect in 2004. Various amendments and modifications have been made to the MDA since its initial release. The MFDS periodically releases relevant notifications that cover...
"The medical device industry is a regulated industry driven by regulations because using medical devices is directly related to human safety," said an official from the Korea Medical Device Industry Association. "If we lead the way in regulations, it also raises the level of our medical device ...
In addition, for other AI medical devices that do require a local clinical trial, they can now be conducted at clinical locations not approved by the MFDS. This is a big change since before this new regulation, all AI medical devices needed clinical trials for MFDS approval, and such trials...
MFDS, the FDA, the Medical Device Safety Administration, the Medical Device Information and Technical Assistance Center (MDITAC), and the National Institute for Food and Drug Safety Evaluation (NIFDS) have primary responsibility for the review, approval, and regulation of medical devices and drugs....
Regulation Issues in Korea and Technical Feasibility Evaluation of 3D Printing-Based Medical Device Repairdoi:10.9718/JBER.2020.41.2.75Sung Uk YunKyoung Won NamThe Korean Society of Medical and Biological Engineering
Gary Slack, Senior Vice President Global Medical Devices BSI GroupRecently enacted changes to the EU Medical Device Directives and the Proposed 2016 EU Medical Device regulation. Xiangdan Kim, General Manager LEPU ConsultationComparison of the Chine...
Since the outbreak of the coronavirus pandemic, governmental and supervisory authorities in the ROK have been promoting increased exports of medical devices, and laws and regulations have been tightened accordingly. Stricter regula...
This duplication of regulatory hurdles is seen by industry stakeholders as a form of redundant regulation, given the similarities in what both the Ministry of Food and Drug Safety and NECA seek to verify. The slow pace of regulatory approval for digital therapeutics (DTx) in Korea, compared to...
KEPCO Signs Agreement with KETEP to Establish "Regulation-Free Test Zone" for Energy TechnologiesKorea Electric Power Corporation (KEPCO), led by CEO Kim Dong-cheol, signed a memorandum of understa... Agartalk, Chairman Kim Chang-soo Returns After 8 Years of Hard Work—Setting a New Standard...
Korea Medical Device Market Size $5.5 billion Projected Growth Rate: 6.2% Korea Pharmaceutical Market Size $23 billion Projected Growth Rate: 2.4% Korea Economic Statistics and Demographics GDP (PPP): $2.2 trillion Per Capita GDP (PPP): $40,111 ...