Medical device registration in Korea: an overview: the latest primer explores how to navigate the regulatory process in this emerging market.Gross, AmesMinot, John
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the chief governmental body responsible for overseeing medical device and pharmaceutical registration, manufacturing, and distribution in South Korea. The MFDS is tasked with establishing...
GPR can act as your ICC in South Korea and assists medical device and pharmaceuitcal companies to register their products with the MFDS.
Key actions for medical device registration Step 1: Classify your device MFDS (Korea FDA) has a list of more than 2,500 device groups with each of a pre-determined class. A complete list of products managed as medical devices is available on the MFDS regulation titled “Regulation for Groupi...
all RWE can be used as clinical data to expedite theregistration of medical devices in Koreathat utilize digital technology like AI, Big Data, and some software applications. The MFDS also said that it may require consultations with applicants to confirm the use of RWE...
‘AI medical device performance evaluation process’ passed the first gateway of the IEC in November last year," Oh said. "Establishing an international standard for AI-based medical devices can lead the global market, so a public-private-academic council has been formed for the registration ...
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the main government agency responsible for overseeing the registration, manufacturing, and distribution of medical devices and drugs in Korea. The mission of MFDS is to develop stand...
In South Korea, medical devices are categorized into four classes based on their level of risk, and procedures vary according to the class. Class I:Registration Class II: Certification Class III and Class IV: Approval from the MFDS For medical devices classified as Class II, Cl...
Click to view:【SFDA registration number】 Click to view: [Korea Export Production License] Click to view: [Medical Device Registration Certificate] Click to view: [business registration card] Click to view: [Jiang Yingshi Science and Culture Award] ...
Ministry of the Interior and Safety (MOIS) is a government organization that is responsible for policing, emergency management, resident registration, the supervision of local governments, the conduct of elections, and public administration in Korea. It was founded in 1998 and is based in Seoul, ...