Labeling requirements for medical devices in South Korea are governed by the Medical Device Act and its associated regulations, as outlined by the Ministry of Food and Drug Safety (MFDS). Below are ten key questions and answers to help medical device manufacturers navigate these requirements.

​

FAQ

​

1. What are the essential elements of a medical device label in South Korea?

Labels must include:

• Product name and model/type.

• Manufacturer’s name and address.

• Importer’s name and address (for imported devices).

• License or certification number.

• Date of manufacture and expiration date, if applicable.

• Instructions for use (in Korean).

• Indication of whether the device contains hazardous substances or is sterilized.

​

2. Are there specific font size requirements?

Yes, labels must use a readable font size to ensure clarity and accessibility. Critical warnings or precautions should be displayed prominently.

​

3. Is it mandatory to include a Korean translation on the label?

Yes, all essential information, including usage instructions and warnings, must be in Korean to ensure accessibility for end-users and healthcare professionals.

​

4. What labeling requirements exist for electronic medical devices?

For electronic devices, compliance with electromagnetic compatibility standards and clear warnings regarding device safety are mandatory. Power requirements and serial numbers must also be included.

​

5. How should sterilized devices be labeled?

Sterilized devices must include clear markings indicating sterilization and the method used (e.g., gamma, ethylene oxide). Labels should also specify handling precautions post-sterilization.

​

6. What about reusable medical devices?

Reusable devices should include clear instructions for cleaning, disinfection, and sterilization between uses, as well as warnings about potential safety issues if reused improperly.

​

7. Are unique device identifiers (UDIs) mandatory?

Yes, South Korea mandates the use of UDIs in compliance with international standards. This system ensures traceability and helps with recalls and post-market surveillance.

​

8. Can additional product information be included voluntarily?

Yes, manufacturers can include extra information, such as QR codes linking to user manuals, provided it does not contradict or overshadow mandatory details.

​

9. What penalties exist for non-compliance with labeling requirements?

Failure to comply can result in fines, product recalls, or suspension of business licenses under the Medical Device Act.

​

10. Where can manufacturers find the official labeling standards?

The official labeling standards are detailed in the “Medical Device Manufacturing and Quality Management Standards” issued by the MFDS. Refer to the National Law Information Center for the latest updates and templates.

This article serves as a starting guide for understanding labeling obligations in South Korea. Adhering to these rules ensures compliance and facilitates smooth market entry. For more assistance, consult the official regulatory texts or professional consultants familiar with South Korean medical device laws.

​

Sources:

• Law.go.kr on Labeling Requirements

​

Update 

 

2. Revision of the Method for Displaying Manufacturer's Address on the "Label"(Article 6 of the Regulations on Medical Device Labeling Requirements)

 

Medical devices distributed in Korea must bear a Korean language "label" following their product approval/certification/notification. The manufacturer information displayed on the label must match exactly with the information provided in the product approval/certification/notification documentation. However, recognizing the challenges in listing all facility addresses for manufacturers with multiple manufacturing sites (e.g., continuous processing), the regulation has been amended to require only the address of the principal manufacturing site (a location available for regular contact or visits).

​

Regulatory intelligence of principal manufacturing site

 

Principal manufacturing site is related to the address of legal manufacturer oft on final product certificate. The legal manufacturer should active influence where to put Principal manufacturing site in each international registration.

​

Impact factor 1 “Made in X”

Principal manufacturing site normally decides that final inspection is completed in subject country and label of “made in x”.

 

Impact factor 2 Subcontractor inspection and related QM renewal

If the medical device is produced other than at Principal manufacturing site, all other production sites must be inspected regularly by legal manufacturer and might be controlled by authority or notified body. The change of production site triggers a change in many countries quality management certificate prior to next renew.

​

Impact factor 3 Change registration

The addition of reduction of production site is in most markets a trigger of change registration. You have to update all critical production documents in this change registration.

 

Our service

​

From MDR in EU or FDA to MFDS

Either for labelling or technical documentation, the gap based in local market to subject market in Korea is the key. We are here to make a feasibility analysis of market entry of medical device in Korea

 

E-learning of regulatory affairs

We don’t have session of registration in Korea but also registration in critical markets as US, ASEAN, Canada and China. Plus you can learn soft skills to be a perfect regulatory affairs manager.

 

Workshop of regulatory LEAN

Taking labelling as example, it is worthy to have a matrix of international labelling requirements. What is effort to release a country specific labelling? Does a MDR label change trigger any action in Korea. Does it make sense to have a master for Korean labelling?

 

We will come to your company and check your regulatory KPI and you will optimise them later on.