ANSWERED ON THIS PAGE:
- What is the role of a Korea License Holder?
- How can we maintain control of our registrations in Korea?
- What are the advantages of an independent representative?
Companies without a physical location in South Korea must appoint a Korea License Holder (KLH) to coordinate the registration of their medical device with the Ministry of Food and Drug Safety (MFDS). The KLH controls the device registration and helps to manage compliance with Korea Good Manufacturing Practice (KGMP) requirements.
Success in Korea depends on the help of an experienced license holder
The Korea License Holder plays a significant role in the MFDS registration process and carries substantial responsibilities. 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 annual reporting of imported devices and subject to unannounced audits from the MFDS. Your KLH must be a licensed Importer, who must purchase the products, inspect incoming shipments for compliance, assist with customs clearance, and maintain responsibility for the products on the market.
Benefits of independent representation in South Korea
Many Korean License Holders are also distributors. Unfortunately, many foreign manufacturers do not realize the license holder controls the original medical device registration, which never expires. This can be a big problem if you ever want to switch or add distributors at a later time.
Emergo is not involved in product sales and offers independent Korea License Holder services, allowing you to change or add distributors as needed without impacting your registrations.
Emergo is the largest in-country representation provider
Emergo represents more than 2,000 medical device and IVD manufacturers in markets around the world. By appointing Emergo as your Korea License Holder, you maintain control of your intellectual property, distribution channels, and post market vigilance. As your Korea Registration holder, we can:
- Submit product registration application
- Submit KGMP Certificate application and assist during on-site audit
- Work with distributor(s) to obtain identical registration to import registered products
- Coordinate Incident Reporting within Korea
- Act as the primary liaison with the MFDS, as required
- Submit insurance reimbursement (HIRA) application, if requested
Contact us for more information about third-party representation services for Korea.
What is the Identical Product Registration process?
The Identical Product Registration process is a way for all of your distributors to import your devices to South Korea by leveraging your original registration obtained through Emergo. It allows you to appoint multiple distributors without compromising your device registration. Emergo can complete the Identical Product Registration process on your distributor's behalf, or we can provide your distributor with the necessary documentation to complete the process.
Why not choose a distributor as our license holder?
It seems practical to hire a distributor as your KLH. However, choosing an independent representative avoids future complications and conflicts of interest. Here are a few reasons not to choose your distributor for this important role:
- Supports regulatory diligence. Some distributors may not be experienced with or aware of the responsibilities and requirements of a KLH.
- Provides flexibility. You won't be tied to one distributor.
- If your distributor is your KLH, it is nearly impossible to change distributors since they control your registrations. Most distributors will not cooperate in a transfer to another distributor.