South Korea
Regulatory Landscape
In South Korea, the Ministry of Food and Drug Safety (MFDS) regulates the medical device industry that ensures that all products meet the safety and efficacy standards. The regulatory framework includes comprehensive guidelines for product registration, clinical trials, quality management systems, and post-market surveillance.
Classification
Medical devices are classified into four classes (I, II, III, IV) based on risk level, with Class I being the lowest risk and Class IV the highest.
| Classification | Risk Level | Description | Registration Pathway | Authority |
|---|---|---|---|---|
|
Class I |
Low |
Devices with minimal risk to patients, such as surgical instruments and bandages. |
Notification |
MDITAC |
|
Class II |
Moderate |
Devices with moderate risk, including some diagnostic equipment and infusion pumps. |
KGMP Certification + Certification |
MFDS |
|
Class III |
High |
High-risk devices, such as implantable devices and life-supporting equipment. |
KGMP Certification + Approval |
MFDS |
|
Class IV |
Very High |
Devices with very high risk, including those used in critical care and advanced surgical procedures. |
KGMP Certification + Approval |
MFDS |
Registration Process
MFDS requires the submission of ‘Technical Documents’ for the certification and approval of medical devices.
A technical document should include details on performance, safety, intended use, mechanism of action, operational structure, raw materials, instructions for use, and test specifications.
Pre-submission: Determine classification, appoint a local representative, and prepare necessary documents.
Process and Timeline: The process timeline can vary, typically taking several months to over a year depending on the device class and complexity.
Substantial Equivalent (SE) devices and Modified Devices
“SE Device” is a medical device (or an IVD) that is equivalent in ‘Intended Use’, ‘Mechanism of Action (MoA)’, ‘Raw Materials, ‘Performance’, ’Test Specification’(not applicable to IVD), ‘Instructions for Use’(not applicable to IVD) with previously approved/certified/notified medical devices. ※ For medical devices in Class II that were approved and certified for more than three times with the equivalent product, MFDS may publicly announce those as a ‘Recognized Substantial Equivalent(SE) devices’,
“Modified Device” is a medical device(or an IVD) that is equivalent in ‘Intended Use’, ‘Mechanism of Action (MoA)’, ‘Raw Materials(Limited to implanted/contacted devices & most of devices are not intended to operate electrically, not applicable to IVD)’ with previously approved/certified/notified medical devices, but not equivalent in ‘Raw Materials’(only applicable to IVD) ‘Performance’, ’Test Specification’ (not applicable to IVD), ‘Instructions for Use’ (not applicable to IVD).
SE Device (Substantially Equivalent Device)
- Determine Classification: Identify the classification of your device according to the MFDS classification listing.
- Appoint a Local License Holder: Appoint a local South Korea License Holder (KLH) to manage your device registration and interact with the MFDS on your behalf.
- K-GMP Certification: For Class II, III, and IV devices, submit an application for Korean Good Manufacturing Practices (K-GMP) certification to an authorized Third Party Auditor.
- Prepare Application: Prepare a notification or registration application with supporting documents for submission to the relevant review body.
- Pay Fees: Pay any applicable fees.
- Review and Approval: The relevant body reviews the application and may request additional information. Upon approval, the review body will issue the marketing authorization and publish the device registration on the MFDS website.
Modified Device
- Assess Modifications: Determine the nature and extent of the modifications to the existing device.
- Determine Classification: Reassess the classification of the modified device if necessary.
- Appoint a Local License Holder: Appoint a KLH to manage the registration process.
- K-GMP Certification: If the modifications affect the manufacturing process or other critical aspects, update the K-GMP certification.
- Prepare Application: Prepare a new or updated registration application with supporting documents detailing the modifications.
- Pay Fees: Pay any applicable fees.
- Review and Approval: The MFDS will review the application and may request additional information. Upon approval, the modified device will be registered and published on the MFDS website.
Korea License Holder
In South Korea, having an in-country representative (also known as a local representative or Korean License Holder) is crucial for foreign medical device manufacturers aiming to enter the Korean market. This representative serves as a bridge between the manufacturer and the Ministry of Food and Drug Safety (MFDS), ensuring adherence to local regulations.
Our Services
Navigating the regulatory landscape in South Korea can be complex. Our team offers specialized services to help you succeed in this market:
We assist with the complete registration process for medical devices and in-vitro diagnostics (IVDs) with the Ministry of Food and Drug Safety (MFDS), including device classification into Class I, Class II, III, IV with or without Substantial Equivalent (S.E.), and streamlining Pre-Market Notification (PMN) and Pre-Market Approval (PMA). Our support extends to obtaining Korean Good Manufacturing Practice (KGMP) certification, facilitating local clinical trials in qualified clinical centers, and appointing a Korean License Holder (KLH) to fulfill local regulatory requirements. Additionally, we manage post-market surveillance activities such as sales data record-keeping and adverse event reporting to maintain compliance with MFDS regulations. Partner with us to ensure your medical devices meet South Korea’s regulatory standards and successfully penetrate the market.
Our Expertise
Our team of subject matter experts cover your complete product life cycle needs across key geographies from preclinical discovery, product design and validation documentation, QMS regulatory affairs, clinical research, QMS/GMP and cybersecurity etc. We are here to accelerate your key countries market access with one-stop solution.
