ANSWERED ON THIS PAGE:
- How are medical devices classified in South Korea?
- How do registration requirements vary by class?
- Which devices qualify for Third Party Review?
Meeting South Korean medical device classification regulations
Before medical device manufacturers can legally sell their products in South Korea, they must comply with medical device regulations set forth by South Korea’s Ministry of Food and Drug Safety (MFDS).
In South Korea, it is extremely important to accurately classify your medical device prior to beginning the MFDS registration process. Improper classification can significantly impact the regulatory approval process and the associated costs.
Determining your device classification in South Korea
The first step in the South Korean registration process is to determine the classification of your device by referencing the rules found in MFDS Notification No. 2017-6: Regulations for Product Classification of Medical Device and Class by Product.
Medical devices in South Korea are classified as Class I, Class II, Class III or Class IV based on increasing risk. A database of device descriptions with corresponding class and category can be found on the MFDS website. When classifying your device, it’s important to consider that some products classified as medical devices in the US or EU may be considered drugs or “quasi-drug” in South Korea.
South Korea device registration requirements by class
MFDS registration requirements vary slightly by device classification and equivalence. Class I devices follow the Pre-market Notification process and do not require a technical file review by the MFDS. They do not require Korea Good Manufacturing Practice (KGMP) certification.
Class II-IV devices with equivalent devices already registered with the MFDS follow the Pre-Market Approval pathway, and do not need to provide clinical evidence. All information must be submitted in Korean, by a qualified Korea License Holder. They also require KGMP certification.
Why choose Emergo to assist with medical device classification?
We have helped hundreds of medical device manufacturers register their devices with South Korea’s Ministry of Food and Drug Safety (MFDS). Here’s how we can help you:
- We can assist you in preparing medical device registration application documents that demonstrate compliance with Korea’s MFDS regulations.
- Our in-depth knowledge of South Korean medical device regulations ensures that we provide the most efficient and cost-effective approval strategy for your device.
- Our Korean License Holder service allows us to submit devices to the MFDS for approval on your behalf and, more importantly, gives you the freedom to add or change distributors as needed.
Our team in Seoul specializes in medical device regulatory consulting and can help you determine the proper classification for your medical device or IVD.
Common questions regarding South Korea's medical device classification
What is the registration process for “substantially equivalent” devices in South Korea?
There are currently approximately 350 Class II products that MFDS considers “Substantially Equivalent,” i.e., well known to the market, such as surgical gloves and surgical drapes. These products are eligible for a simplified approval. The process includes submission of a simple application and product testing to a TPR, which then goes through an expedited review. The official approval timeframe for Class II SE devices is 5 days.
How do we determine if our device is substantially equivalent?
In order to qualify for this simplified review, the raw material information must exactly match the raw material of the product identified as Substantially Equivalent; otherwise, a technical review will be required.
Which device classifications qualify for third party review?
Class II applications with an equivalent device already registered in Korea can be reviewed by an MFDS accredited Third Party Reviewer (TPR). Applications reviewed by a TPR are approved faster than those reviewed by MFDS; however, there are additional costs. Class III and IV registrations must be reviewed by MFDS directly.