If you’re a foreign manufacturer looking to place your medical device on the South Korean market, one of the first regulatory steps is appointing a South Korea authorized representative medical device commonly referred to as a Korea AR or MFDS local agent. This article explains who can act as your authorized representative, how to appoint one, and what responsibilities they hold under Korean law.
Why You Need a South Korea Authorized Representative
South Korea’s Ministry of Food and Drug Safety (MFDS) regulates all medical devices sold in the country. If you’re not physically based in South Korea, the MFDS requires that you appoint a local authorized representative—a Korean entity that can act as your official liaison with the regulatory authorities.
This representative plays a critical role in ensuring your product’s compliance with MFDS regulations, from registration to post-market surveillance.
Who Can Be Your Korean Authorized Representative?
Your medical device Korea AR must be a legal entity located in South Korea. Typically, this can be:
- A regulatory consultancy based in Korea
- A Korean distributor (though this limits flexibility)
- A third-party service provider specializing in regulatory affairs
It is not mandatory to appoint your distributor as the authorized representative. In fact, many manufacturers prefer using an independent Korea AR to retain control over distribution channels.
How to Appoint an MFDS Local Agent?
Appointing a MFDS local agent involves the following key steps:
- Select a Qualified Representative
Choose an entity with expertise in MFDS requirements and experience handling medical device registration and post-market obligations.
- Draft and Sign a Written Agreement
You must formalize the appointment with a signed agreement that clearly outlines:
- Scope of responsibilities
- Duration of the agreement
- Liability and confidentiality clauses
The MFDS does not provide a template, so legal review is recommended.
- Provide a Power of Attorney (PoA)
A notarized Power of Attorney may be required for certain device classifications. This allows the Korea AR to act on your behalf with regulatory bodies.
- Submit the Representative’s Details to MFDS
The Korea AR will submit their information as part of your product registration dossier. You cannot proceed with registration without this.
Key Responsibilities of a Korean Representative
Your Korean representative has both legal and regulatory obligations. These typically include:
- Product Registration
Handling submissions to MFDS, including:
- Technical documentation
- Clinical data (if applicable)
- Good Manufacturing Practice (GMP) certifications
- License Management
Maintaining the device license throughout its lifecycle, including renewals and updates.
- Post-Market Surveillance
Monitoring device performance, managing adverse event reports, and coordinating product recalls if necessary.
- Communication with MFDS
Acting as your official point of contact for any MFDS inquiries or inspections.
- Labeling and Advertising Compliance
Ensuring your device packaging and promotional materials comply with Korean language and regulatory standards.
Changing or Terminating Your Korea AR
If you wish to change your Korean representative, a formal termination of the existing agreement is needed. The new representative must then take over license transfer procedures with MFDS—this can take several weeks, depending on the device class.
How OMC Medical Can Help
Appointing the right South Korea authorized representative medical device is critical—and OMC Medical is here to simplify the process with local expertise and direct support.
OMC Medical has an established office in South Korea, allowing us to act as your MFDS local agent directly. This means faster communication with the MFDS, hands-on support for inspections, and real-time assistance with regulatory updates and compliance matters.
We offer:
- Direct Korea AR services through our local office
- Full support with product registration, labeling compliance, and license maintenance
- Representation for all device classes, including Class I, II, III, and IV
- Ongoing post-market surveillance and adverse event handling
- Independent AR services so you retain full control over distribution
By choosing OMC Medical as your Korea AR, you gain a reliable in-market presence with global regulatory experience.
Conclusion
Navigating South Korea’s medical device regulations can be complex, but appointing the right authorized representative lays the groundwork for smooth market access and long-term compliance. Your Korean representative responsibilities extend far beyond registration—they are your regulatory lifeline in-country.
With a local office in South Korea and global regulatory expertise, OMC Medical offers a strategic advantage to manufacturers looking to enter or expand in the Korean market. Whether you need full-service representation or targeted support, we’re here to help every step of the way.
Ready to register your medical device in Korea? Contact OMC Medical today to get started.
