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.
March 1, 2024
Approximately 5 minutes
South Korea IVD Registration: Risk Classification and Expedited Third-Party Review
South Korea IVD Device Registration Pathways (MFDS)
In South Korea, the registration of In-Vitro Diagnostic (IVD) devices is governed by the Ministry of Food and Drug Safety (MFDS). The time and cost for registration depend on the device's risk classification (Class I-IV) and whether a Substantial Equivalent (S.E.) or predicate device is already registered locally.
Classification and Review Process
South Korea's classification system for IVDs aligns with GHTF guidelines. The primary determinant of the regulatory pathway is the risk class and the existence of an S.E.
| Class | Predicate (S.E.) Status | Review Pathway | Reviewer | Time (Working Days) |
|---|---|---|---|---|
| Class I | Not Applicable | Pre-Market Notification (PMN) | MFDS | 5 days (1 week) |
| Class II | With S.E. | Third-Party Review | Certified Reviewer | 35 days |
| Class II | Without S.E. | Safety & Efficacy Review (SER) | MFDS | 80 days |
| Class III/IV | With S.E. | Pre-Market Approval (PMA) | MFDS | 65 days |
| Class III/IV | Without S.E. | Safety & Efficacy Review (SER) | MFDS | 80 days |
Key Regulatory Considerations
- Local Agent: Foreign IVD manufacturers must appoint a licensed Local Agent to submit and hold the registration certificate in Korea.
- Expedited Review: Class II devices that successfully demonstrate Substantial Equivalence qualify for an expedited review by one of the six designated Third-Party Reviewers. This significantly reduces the time-to-market compared to the 80-day SER route.
- Predicate Determination: Predicacy is determined by a formal review based on 5 to 6 key categories, ensuring the comparison is rigorous and meets MFDS standards.
- Local Fees: Registration fees vary by pathway, ranging from approximately US$35 for Class I PMN to US$1,500 for the Class II third-party review.
Related Articles
Approximately 5 minutes
South Korea Medical Device Registration: MFDS, KGMP, and the Substantial Equivalent Pathway
A guide to South Korea's medical device approval process via the MFDS, outlining the classification system, the requirement for Korean Good Manufacturing Practices (KGMP), and the expedited registration routes based on the existence of a Substantial Equivalent (S.E.).
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.