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What is Korean MFDS Approval?

South Korea Medical Devices are regulated by the Ministry of Food and Drug Safety (MFDS), formerly called the Korean Food and Drug Administration (KFDA). MFDS is the chief legislative body in South Korea accountable for supervising: (1) medical device registration, (2) manufacturing, and (3) distribution. Medical Device Manufacturers have to adhere to the requisites of the Medical Devices Act and they have to register their medical devices with the MFDS before entering the Korean market. 

Why is Korean MFDS Approval Important?

Medical device manufacturers must register their medical device with MFDS and the product launch, sales, and distribution in the Korean market can happen only after MFDS Approval. 

How Can We Help?

Western Medical Device Manufacturers might find the Medical Regulatory System of Korea to be slightly complicated because of its rigorous requirements and Korea’s distinctive business culture. If you are looking for a cost-effective and speedy way of registering your medical device in Korea, then you can very well rely on us. Our regulatory experts are here to take care of Korean MFDS Approval of your medical device so that you can bring your product to the Korean market without any hassles or delays!

 

Korean MFDS Approval process involves the following steps and we are glad to assist you with all these:

  1. Classify your device as one among Class I, Class II, Class III or Class IV device based on its risk level

  2. Manage your medical device registration with Korean MFDS

  3. If your device is classified as Class II or Class III or Class IV type, then you have to obtain the Korean KGMP certification. KGMP is  the abbreviation of Korea Good Manufacturing Practices

  4. If your device is classified as Class II or Class III or Class IV type, then submit your device for testing in Korea or evidently show testing results of equivalent devices

  5. Prepare Pre-Market Notification if your device is classified to be a Class I type. In the case of Class II device, prepare registration application encompassing technical file, KGMP Certification, and appropriate test reports. Make sure that the registration application is prepared in the Korean language. In the case of Class IV device, please make sure that the technical file is prepared as per STED format

  6. In the case of Class I or Class II devices, the documents specified in Step 5 have to be submitted to the MDITAC. Class III or Class IV device documents have to be submitted to MFDS in order to review the safety and efficacy. Application fee has to be paid for all class devices

  7. Class I device anticipates a notification from MDITAC, whereas Class II or Class III or Class IV device requires Pre-Market Approval License from MDITAC or MFDS. Notification and approval will be published on their website

  8. Now you are all set to market your device in Korea!

This is just an overview. Each step above has a detailed process to be followed, which we can work upon with ease!