Medical Device Registration in South Korea (MFDS)

CMC Medical Devices offers registration and approval of medical devices in South Korea

Experts in global registration in Korea, we ensure that your product meets all MFDS regulatory requirements for successful entry into the Korean market.

Korean License Holder (KLH)

A registered office in Korea or a Korean license holder must be designated to act as a liaison with the MFDS.

The registration period is from 2 to 16 months, depending on the product classification. For Class I, a basic KGMP certificate can be obtained. If your device belongs to Class I (specially controlled), Class II, Class III, or Class IV, a detailed technical dossier must be submitted to the MFDS along with a sample device for testing.

CMC can assist you in entering the Korean market by registering your products with the KFDA.

Select CMC as your MFDS Korea

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Frequently asked questions about south korea medical device regulations

Do I need to register my products with MFDS if I want to sell them in Korea?

Yes, any company wishing to market food, drugs, medical devices, or cosmetics in South Korea must register their products with the MFDS to comply with local regulations.

What types of products are regulated by the MFDS?

The MFDS regulates a wide range of products, including food and beverages, pharmaceuticals, medical devices, cosmetics, and health supplements.

What are the steps for registering a product with MFDS?

The registration process typically involves submitting product information, safety and efficacy data, labeling, and quality assurance documentation. Specific requirements vary depending on the product category.

How long does the MFDS approval process take?

The duration of the approval process can vary significantly depending on the type of product and the completeness of the submitted documentation, but it typically ranges from a few months to over a year.

Why appoint CMC Medical Devices as your MFDS Korea?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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