Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
February 26, 2024
Approximately 5 minutes
South Korea Medical Device Registration: MFDS, KGMP, and the Substantial Equivalent Pathway
South Korea Medical Device Registration: Key MFDS Requirements
Medical device regulation in South Korea is overseen by the Ministry of Food and Drug Safety (MFDS), operating under the Medical Device Act. Foreign manufacturers must appoint a Licensed Local Agent (KLH) to submit the application, and all documentation must be provided in the Korean language.
Classification and Registration Pathways
South Korea's classification system closely follows the Global Harmonization Task Force (GHTF), categorizing devices from Class I (low risk) to Class IV (high risk). The registration pathway is heavily dependent on the device's risk class and the existence of a Substantial Equivalent (S.E.) product already registered in Korea.
| Class | Pathway | Reviewer | Approximate Time |
|---|---|---|---|
| Class I | Pre-Market Notification (PMN) | MDITAC | 0 days (Accepted upon submission) |
| Class II with S.E. | Pre-Market Approval (PMA) | Third Party | 25 days |
| Class III/IV with S.E. | Pre-Market Approval (PMA) | MFDS | 65 days |
| Class II/III/IV without S.E. | Safety & Efficacy Review | MFDS | 80 days |
Quality System Conformity (KGMP)
Unlike many international markets where ISO 13485 is sufficient, South Korea mandates a Korean Good Manufacturing Practices (KGMP) certification for manufacturers of Class II, III, and IV devices.
- Validity: While the device registration license does not expire, the KGMP Certificate must be renewed every three years.
Identical Product Re-registration
A unique feature of the Korean system allows a new Independent License Holder (KLH) to rapidly re-register an identical product license based on an existing registration, provided the current license holder provides approval/attestation. This process is significantly faster and more cost-effective than a full new application, allowing manufacturers to maximize distribution channels.
Related Articles
Approximately 5 minutes
South Korea IVD Registration: Risk Classification and Expedited Third-Party Review
An overview of the South Korean MFDS registration for In-Vitro Diagnostic (IVD) devices, highlighting the GHTF-aligned classification, the role of predicate devices (S.E.) in accessing expedited third-party review for Class II, and the Safety and Efficacy Review (SER) route.
Approximately 5 minutes
Mandatory Korea Good Manufacturing Practice (KGMP) Certification for South Korea Device Approval
KGMP certification is mandatory for Class II, III, and IV device registration in South Korea. The process, submitted by a local importer, involves either an MFDS document review or an on-site audit, with the certificate valid for three years.
Approximately 5 minutes
South Korea Medical Device Labeling Requirements: MFDS Mandates and Korean Language Rule
Mandatory labeling for medical devices in South Korea is governed by the MFDS Medical Device Act. All labels, including the container and Instructions for Use (IFU), must be in Korean and contain specific identifiers like approval number, product name, and manufacturing data.
Approximately 5 minutes
South Korea Post-Market Surveillance (PMS): Tracking, Vigilance, and Penalties
An overview of South Korea's Post-Market Surveillance (PMS) requirements under the MFDS, covering mandatory tracking devices, adverse event reporting, and the severe administrative sanctions for non-compliance, including fines and license revocation.
Approximately 5 minutes
South Korea License Maintenance: Monthly Supply Reporting and Amendment Requirements
License maintenance in South Korea requires manufacturers to report any license amendments to the MFDS and comply with mandatory monthly supply reports for all device classes (Class IV to I) via the integrated information system, excluding home-use devices.