Chapter 1 Korean Regulatory Information abstract

1. Administration and abstract

Ministry of Health and Welfare (MHW), is mainly responsible for the management of food、 medicine、makeup and medical device. In accordance with [Medical Device Act [MDA]]. The Ministry of Food and Drug Safety (MFDS) under the Ministry of Health and Welfare is responsible for the supervision of medical devices.

2. Administrative Regulation

[Medical Device Act [MDA] ]

[Enforcement Decree of MDA]

3. Risk Level Classification of Medical Device and IVD Products

【Medical Device (except IVD)】

【IVD】

4. Entry requirements

MFDS require the submission of “Technical documents” for the certification and approval of medical devices.

The process of the certification and approval of medical devices in Korea needs to submit: Technical documents including the information related to medical device quality, such as performance and safety, including "Intended use", "Mechanism of Action (MoA)", "Operational (functional) structure", "Raw materials", "User Instructions ", "Test specifications", etc. KGMP certification is required for all products except for Class I products. 

5. Language

Korean and English.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Registration Cycle and Official Fee

3. Registration timeline

Based on the risk classification of medical devices, there are different approaches for market access for each class of device (according to the project experiments of Wiselink). The official audit time for Class I devices is about 2 months, Class II devices is about 4-7 months, and Class III and IV is about 145 working days.

4. Registration Fee

Chapter 3 FAQ

Q: Is the registration of medical devices in Korea all approved by MFDS?

A: The registration of medical devices in Korea is mainly approved by MFDS, but the audit bodies corresponding to products with different risk levels are different.

①  Class I medical devices: Certified by the Medical Device Information and Technical Assistance Center (MDITAC), the audit time is approximately 2 months.

② Class II medical devices: Certified by MDITAC, the audit time is approximately 4-7 months. In addition, the certification method of Class II devices is similar to that of the US FDA 510K, which proves the safety and effectiveness of the product by comparing the consistent products.

③Class III and Class IV medical devices: Directly approved by MFDS, the audit time is approximately 145 workdays. Class III and Class IV devices are subject to safety and effectiveness audit.

Q: Which typed of medical devices in Korea need to be tracked and controlled?

A: A total of 52 types, including 48 types of medical device which implanted in the human body for more than one year and 4 types of life-supporting devices that can be used outside of medical facilities, for which the relevant parties are required to keep records in accordance with the regulations, including the number of products, the date, the user and other information.

Q: Is the Korean product registration certificate transferable?

A: Yes.

Q: How long is the validity period of the Korean product registration certificate?

A: Korean medical device registration certificates are usually valid for 5 years. After the expiration, the manufacturer needs to apply for re-registration or renewal to maintain the market eligibility of the product. Renewal applications must be submitted before the end of the registration period to avoid registration lapses and disruption of marketing.

During the renewal process, the Korea Food and Drug Safety (MFDS) may request to update technical documentation、 test data, or other relevant information. Renewal applications need to be submitted in advance of the expiration of the certificate to ensure that renewal approval is obtained before the expiration of the validity period

Q: Is there a GTHF that can speed up the Korean audit?

A: The GTHF's rules do not directly speed up the audit process in Korea. However, understanding and following the GHTF rules will help companies better prepare registration materials and improve the quality of registration applications, which may indirectly improve registration efficiency. First, although Korea authority will refer to GHTF's classification and principles for medical device registration, the specific registration requirements and processes are still determined by Korean regulations. Second, in order to speed up the registration audit of medical devices, the fast-track or priority audit mechanism provided by the MFDS in Korea is usually based on the urgency, innovativeness, or importance of the product rather than whether the company understands the rules of the GHTF.

Q: Is Korean KGMP system certificate transferable?

A: Yes. However, it requires the consent and authorization of the original holder, and it needs to be notarized

Q: Does Korea KGMP conduct audits of manufacturer site?

A: KGMP certification requires a manufacturer's on-site audit. ‌

According to the Korean Medical Device Act, Class III and IV medical devices are subject to the MFDS approval process, while Class I and II devices are certified and approved by the Medical Device Information and Technical Assistance Center (MDITAC) and MFDS, respectively. Manufacturers must undergo an on-site audit by an MFDS accredited body to obtain a KGMP certificate.

Among them, manufacturers of Class II, III and IV medical devices are required to conduct quality system conformity assessment to ensure that their quality systems comply with KGMP standards. The corresponding manufacturer must undergo an on-site audit to verify that its production process and management system comply with the requirements of KGMP.

In addition, to streamline the audit process, the MFDS allows desktop audits using the results of the Medical Device Single Audit Program (MDSAP) audits, but this is only applicable to initial audits, additional audits, and change audits, and renewal audits must still be conducted on-site.