Successful Product Approval in South Korea
In recent years, South Korea has increasingly become a major market for medical devices. To introduce and market medical devices in South Korea, companies must meet the requirements set by the Ministry of Food and Drug Safety (MFDS). These requirements vary depending on the risk class of the medical device. For example, manufacturers of Class II medical devices and higher must demonstrate compliance with the Korean Good Manufacturing Practice (KGMP) quality management system requirements. A local representative in the form of a Korea License Holder (KLH) is also required for non-Korean companies.
What makes our seminar unique?
In this interactive seminar, you will not only learn about the various requirements, but we will also use your products as examples to show you which approval process is right for you and how to navigate the approval process.
Numerous illustrative examples and practical tips will help you successfully obtain approval for your product in South Korea.
- Content
- Regulatory and Legal Requirements
- Organization of the MFDS
- Overview of the Legislation
- Korea License Holder (KLH)
- Access to the Korean Market
- Product Classification
- Notification of Class I Medical Devices
- Registration of Class III and IV Medical Devices
- Determining an Appropriate Approval Procedure
- Language Requirements: Korean
- Quality Management Requirements: Korea Good Manufacturing Practice (KGMP)
- Your Benefits
- You will learn about the various requirements for product approval in South Korea.
- You will walk through the approval process for your specific product during the seminar.
- You will understand the structure of the regulatory authority, the MFDS, and know where to submit each application or registration.
- You will receive practical solutions tailored to your business.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- RA Specialists
- QM Specialists
- Medical device developers and manufacturers
- Project managers
- Medical device manufacturers and exporters
