10월 21, 2022
Medical devices in South Korea are regulated by the Ministry of Food and Drugs Safety (MFDS), formally known as the Korean Food and Drug Administration (KFDA). MFDS requires all foreign manufacturers wishing to market their devices in South Korea to appoint a Korean License Holder (KLH) to register their devices with the MFDS. The current article answers the major questions posed by the device and IVD manufacturers to appoint a KLH.
- Who is Korean License Holder (KLH)?
A KLH is an entity with an established place of business in Korea responsible for placing the device on the Korean market on behalf of the foreign manufacturer. The KLH is the owner of the product license and is required for all risk classes of medical devices and in-vitro diagnostic (IVD) devices.
- What are the prerequisites for appointing a KLH?
As the KLH oversees the foreign manufacturer’s device in South Korea, MFDS expects the KLH to fulfil the following prerequisites:
- KLH must be a resident of South Korea
- Must have a registered office in South Korea with a business license
- Must register with the MFDS as an authorized KLH with a medical device import license
- Must register a quality manager in compliance with MFDS requirements
- Who can act as a KLH?
Appointing a reliable KLH is a critical pre-requisite for registering the device with MFDS, South Korea. The foreign manufacturers must diligently evaluate the possible options for appointing an KLH. The manufacturer can -
- Appoint a distributor as KLH
- Appoint an independent entity as a KLH
- Set up a subsidiary in South Korea and registering as a KLH
- What are the advantages of having an independent KLH?
The manufacturer can choose to appoint a distributor as their KLH. A reliable independent third party consultant helps prevent possible issues and does not have any conflict of interest. An independent company appointed as your KLH may -
- Ensures complete Regulatory diligence as it is aware of the responsibilities and requirements of a KLH.
- provides flexibility of appointing multiple distributors under one product license.
- Ease the process of changing the KLH in the future.
- Can I have two KLHs for a single device?
Yes, a single device can have two KLHs for importing medical devices. It will be distinguished by the KLH's name on the product certificate.
- What are the responsibilities of a KLH?
The KLH of the foreign manufacturer can register the device with the MFDS. The following are the responsibilities of a KLH:
- Product registration and KGMP Certification with the MFDS
- Reimbursement registration
- Annual importing record report submission
- Monthly UDI report submission
- Implement license amendments for any design changes of the product
- Korean labeling and DMR maintenance
- Is the KLH responsible for carrying out QMS-related activities?
On behalf of the foreign manufacturers, the KLH shall submit the applications for KGMP certification for Class II, III, and IV devices and assist foreign manufacturers with the QMS audits. KLH is also accountable for communicating MFDS queries to the manufacturers.
- Will the KLH be responsible for Post Market Surveillance (PMS) activities?
Once the medical device is approved and is marketed in South Korea market, the KLH must ensure certain aspects of medical device distribution, such as:
- Medical device indication and description
- Medical device advertising
- Medical device side effects
- Detect foreign objects
- Medical device re-evaluation
- Medical device re-examination
- Medical device tracking management
- Reporting and inspection, on-site inspection of overseas manufacturing plants
- Corresponding for inspection orders, collection and disposal, and suspension of use orders by MFDS
- Report the importing and distributing history depending upon the UDI with the Health Authority
- Medical device supply history report
- Medical Device Renewal
- Do we need to include the details of KLH on the label?
Yes, the MFDS requires manufacturers to include the information (name and registered address) of the KLH on the medical device and IVD labels as a mandatory criterion to sell their devices in South Korea.
- How do I change the KLH for my registered device, which is marketed in Korea?
The manufacturer can appoint a second KLH by establishing a contract and by re-registering the device under another KLH.
The Korea License Holder plays an essential role in the device registration process and is also responsible for carrying out critical activities for your devices. Your KLH represents your company and devices and is identified on your MFDS device registration certificates (Certificate of Product Approval). Once the product is approved, your license holder is responsible for the annual reporting of imported devices and is subject to unannounced audits from the MFDS. Hence it is crucial to evaluate and finalize your KLH carefully.
To know more about the Korean medical device registration requirements, contact Freyr today.