General Labelling Instructions for Medical Devices in South Korea 

1.The label shall be printed in the ink, imprint, or stamp that cannot be easily erased, using Korean language in typefaces that are easy to read, such as the East Asian Gothic typeface. 

1.1. Letters on the label shall not overlap with one another and shall also be in a color that is distinct from the background color, such as black letters on a white background. 

2. Where a label is affixed on the container or outer package of a medical device, it shall be affixed where the consumer can easily find it, such as on the side of the container or outer package normally visible to the consumer during its purchase or after the installation. The label shall not be easily removed from the product. 

3. The label shall be based on the information on the license, certificate, and notification. 

Labelling Instructions on Containers or Outer Packages 

1. The manufacturer or importer’s business name and address are listed based on their manufacturing license. However, manufacturers in a knowledge industry center registered under Article 28-2 (3) of the Industrial Cluster Development and Factory Establishment Act can only list the main manufacturing site, which can be contacted or visited at any time. 

2. The date of manufacture should be listed in standard formats like “YYMM,” “YYYY-MM,” or with the day included, such as “YYMMDD” or “YYYY-MM-DD.” If a different order is used, an example must be provided on the packaging to help consumers identify the date easily. 

3. The expiry date shall be written in the same way. However, the expiry date may be listed according to the classification in the following: 

3.1. When the expiry date is listed with the date of manufacture, it should be expressed as “until ○○^th day from the date of manufacture” if the expiry is within one month; “until ○○ months from the date of manufacture” if it is between one and twelve months; and “until ○○ years from the date of manufacture” if it is more than one year. 

3.2. If multiple products with different expiry dates are packaged together, only the earliest expiry date should be listed. 

4. Weight or packaging units shall be specific units sold in accordance with the information on the license, certificate, and notification. 

5. The word “medical device” shall be printed using bold letters, text boxes, etc. 

Instructions about Labelling Requirements on Package Inserts 

1. Instructions for use: Instructions for use approved, certified, and notified shall be listed; 

1.1. Where the instructions for use under item (a) need to be further explained, additional details may be included in the label. In such case, the inserts shall include the phrase, “See the User Manual for details”; 

1.2. For medical devices for personal use, the preparation before use, how to operate, how to store and care after use shall be described in steps to take to use the product to ensure that consumers easily follow the instructions; 

2. Precautions for use: The precautions for use that have been approved, certified, and notified shall be included in the label; 

2.1. In the precautions for use, items for “Warning” may printed using bold letters, text boxes, etc. to make them stand out from other items, and the titles of other items may also be printed using bold letters, text boxes, etc. to make them stand out; 

3. Matters concerning maintenance and inspections where maintenance and inspections are required:  Methods and procedures of maintenance and inspections shall be described in steps according to the information on the license, certificate, and notification; 

3.1. Where a repeatedly used medical device requires an action to be taken for reuse of the device, the action shall be described in the matters concerning maintenance and inspections. Provided that, it may be omitted if the information overlaps with the precautions for use;  

3.2. Where there is a route for obtaining information on maintenance and inspections or receiving associated services, it shall be included in the label; 

4. For storage methods, appropriate methods for the medical device shall be described in accordance with the license, certificate, and notification; 

5. The words “medical device,” “single use,” “do not reuse,” “for a clinical trial,” and “do not use for purposes other than for a clinical trial” shall be printed using bold letters, text boxes, etc. 

Recommendations 

To ensure the correct use of medical devices by persons with disabilities, senior citizens, etc., it is recommended that labels be also be written in Braille or voice codes. 

When providing details of the content of the license, certificate, and notification via a website, it is recommended that sign language, subtitles, audio, enlarged text, etc. be used to ensure that persons with disabilities, senior citizens, etc. can use the device at the same level as persons without disabilities without an assistive device. 

Restrictions 

None of the information provided by the following shall be indicated or written on a container, an outer package, packing material, or a package insert of a medical device:  

1. False or misleading information; 

2. Performance, efficacy, or effect, which are not approved or certified, or are different from the report filed 

3. Instructions for use or use period that may cause harm to health or hygiene. 

Frequently Asked Questions: Labelling Requirements for Medical Devices in South Korea

1. What information must be included on medical device labels in South Korea?

Labels must include the device name, manufacturer details, expiration date, storage conditions, usage instructions, and warnings in Korean.

2. Are labels required to be in the Korean language?

Yes, all medical device labels must be translated into Korean to ensure compliance with MFDS regulations and to provide clear information to users.

3. Do imported medical devices need additional labeling for South Korea?

Yes, imported devices must include a Korean label that complies with MFDS requirements, even if the original label is in another language.

4. What are the penalties for non-compliance with labeling requirements?

Non-compliance may result in fines, suspension of product distribution, or withdrawal of regulatory approval for the medical device.

5. Can the authorized representative handle labeling compliance for foreign manufacturers?

Yes, the authorized representative can assist foreign manufacturers in ensuring that labels meet all MFDS medical device labeling regulations.