Medical Device Regulatory Services in South Korea

We help you register and launch medical devices in South Korea with MFDS regulatory expertise and reliable local support. Work with Artixio to manage South Korea’s MFDS device approvals and stay compliant with evolving regulatory standards.

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Medical Devices Regulatory Solutions in South Korea

At Artixio, we simplify MFDS approvals in South Korea—guiding medical device firms through registration, testing requirements, and regulatory liaison support.

The Ministry of Food and Drug Safety (MFDS) is the Regulatory body regulates the Medical Devices in South Korea. The registration makes sure that the devices meet safety and performance standards before they can be marketed.

South Korea Medical Device Regulatory Services

Key Regulations for Medical Devices in South Korea

Medical Devices Act (MDA)

Classification of Medical devices

In South Korea, devices are classified to Class I, II, III, and IV depending on their risk level. Class I devices have low risk to patients, while Class IV devices are high risk, complex devices. Class I and a few Class II devices need certification by the NIDS, whereas new Class II devices, Class III devices and Class IV devices need approval by the MFDS.

Medical Devices Registration Process in South Korea

Documents Required for Registration of Medical Devices in South Korea

Administrative Documents:

Technical Documentation:

Intended Use
Mechanism of Action (MoA)
Operational (Functional) Structure
Raw Materials
Instructions for Use
Test Specifications
Clinical Trial Data (if applicable)

Medical Device Registration & Regulatory Services in South Korea

Our Regulatory and Market Access experts based in South Korea, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in South Korea. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.

From strategy and registration to post-approval support, Artixio helps medical device companies navigate South Korea’s MFDS requirements with reliable, practical regulatory guidance.

Why Choose Artixio for Medical Device Approval in Singapore?

FAQs

What is the requirement for quality management system (QMS) in South Korea?

The devices Manufacturers other than Class 1 must submit quality system documentation to receive certification to KGMP as part of the medical device registration process. It is specific to the manufacturing site and local applicant/importer and KGMP is aligned with ISO 13485:2016.

Doe the local representative for medical device registration in South Korea is required for foreign manufacturer?

Yes, to manage regulatory submissions and compliance foreign manufacturers must appoint a local authorized representative.

What is the validity of Medical Devices registration in South Korea?

The registration is valid for 5 years and can be renewed after that.

What are the requirements to be a license holder in south Korea?

To be a license holder, the manufacturer should have a registered place of business in South Korea with a full time quality responsible person. If foreign manufacturers, they can appoint a local agent/license holder to apply for registration of medical device in with MFDS.