This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission)

MFDS requires the submission of 'Technical Documents' for the certification and approval of medical devices.

Medical devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS). The legal framework for the regulatory system is based on the ...

Medical device regulations in South Korea are overseen by the Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), ...

All companies planning to sell a medical or in vitro diagnostic (IVD) device in South Korea must register their product with the Ministry of Food and Drug ...

In South Korea, the regulatory submission process for medical devices is overseen by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea ...

Medical Devices in South Korea are regulated by the Ministry of Food and drug safety (MFDS) formerly known are the Korean Food and Drug Administration (KFDA).

The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the Regulatory body regulates the Medical ...

To register a medical device in South Korea, you must obtain a Manufacturing Business License if you are a domestic manufacturer, or an Import Business License ...

Regulatory Authority. The Ministry of Food and Drug Safety (MFDS). The Korea Medical Devices Industry Association (KMDIA), the largest association of over 900 ...