Your Trusted Regulatory Partner for Success in South Korea
Engaging with MFDS
Flexible regulatory terms, tailored regulatory intelligence, and local representation in South Korea for seamless compliance and market access
OMC Medical South Korea – Your Trusted Partner for MFDS Compliance
At OMC Medical, we specialize in guiding medical device manufacturers through South Korea’s complex regulatory landscape. With expertise in MFDS registration, KGMP certification, and market access, we ensure a smooth approval process for your products. Whether you need support with product classification, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in South Korea provides end-to-end regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the dynamic South Korean healthcare market
OMC Benefits
Regulatory Expertise – Our team has in-depth knowledge of MFDS regulations and ensures seamless compliance.
Local Representation – We act as your Authorized Korean License Holder (KLH) to facilitate approvals and market entry.
Faster Market Access – With streamlined processes and regulatory insights, we help you reduce approval timelines.
KGMP Certification Support – Assistance in obtaining and renewing Korean Good Manufacturing Practice (KGMP) certification.
End-to-End Compliance – From classification to post-market surveillance, we provide full regulatory support.
Cost-Effective Solutions – Transparent pricing with no hidden fees, ensuring value for your investment.
Dedicated Support – Personalized guidance and quick response to all regulatory inquiries.
Trust OMC Medical for hassle-free medical device registration and successful market entry in South Korea
Discover tailored solutions across medical devices & IVDs, Cosmetics, pharmaceuticals, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
South Korea’s medical device and IVD market is strictly regulated by the Ministry of Food and Drug Safety (MFDS), requiring full compliance for market approval. OMC Medical streamlines this process by providing expert assistance in MFDS registration, local representation (KLH), KGMP certification, supplier audits, QMS implementation, process validation, and regulatory documentation. Our comprehensive services ensure smooth market entry, ongoing compliance, and a strong competitive position in South Korea’s rapidly advancing healthcare sector.
Partner with OMC Medical for hassle-free regulatory approval in South Korea
South Korea’s cosmetics market is regulated by the Ministry of Food and Drug Safety (MFDS), requiring strict compliance for product registration, safety assessments, and labeling. OMC Medical streamlines this process by offering expert guidance in MFDS approvals, local representation, supplier audits, and ongoing compliance management. We help brands navigate South Korea’s evolving cosmetic regulations, ensuring seamless market entry and long-term success in one of the world’s leading beauty markets.
South Korea’s pharmaceutical market is regulated by the Ministry of Food and Drug Safety (MFDS), requiring strict compliance for drug registration, clinical trials, quality control, and post-market surveillance. OMC Medical simplifies this process by providing expert support in MFDS approvals, local representation, GMP compliance, supplier audits, and regulatory documentation. We help pharmaceutical companies navigate South Korea’s evolving regulatory landscape, ensuring smooth market entry and sustained compliance in one of Asia’s most advanced healthcare markets
OMC Medical provides expert support for businesses seeking market entry in South Korea by acting as an Authorized Representative and ensuring compliance with MFDS regulations. We assist with regulatory submissions, appointing a local Korean License Holder (KLH), and managing communications with South Korean authorities. Our expertise in South Korea’s evolving regulatory landscape ensures a smooth approval process, enabling seamless market access for medical devices, pharmaceuticals, and cosmetics.
With OMC Medical, you gain a trusted partner to navigate complex compliance requirements efficiently and accelerate your product’s entry into the South Korean market
OMC Medical provides expert translation services tailored to South Korea’s regulatory landscape, ensuring compliance with MFDS requirements. As an ISO 17100:2015 certified provider, we specialize in accurate translations of medical, pharmaceutical, and clinical documents, including IFUs, user manuals, and legal texts.
Our services help businesses navigate regulatory approvals and facilitate seamless market entry in South Korea, ensuring clarity, accuracy, and compliance with local regulations.
About OMC
OMC Medical is a leading regulatory consulting firm specializing in global market access for medical devices, IVDs, pharmaceuticals, and cosmetics. With expertise in MFDS regulations, we assist businesses in navigating South Korea’s complex compliance landscape, including product registration, quality assurance, local representation, and regulatory intelligence.
Our tailored solutions ensure smooth approvals and seamless market entry, making OMC Medical a trusted partner for regulatory success in South Korea
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
Have a Business Query? Let us Talk
Get Your Medical Device Approved in South Korea
South Korea has a strict regulatory framework governed by the Ministry of Food and Drug Safety (MFDS) to ensure the safety and efficacy of medical devices. If you are a manufacturer or distributor looking to enter the South Korean market, understanding the approval process is essential.
OMC Medical provides expert guidance in MFDS registration, KGMP compliance, local representation, regulatory submissions, and post-market surveillance, ensuring a seamless market entry for your medical devices in South Korea
Get MFDS Approval Fast
Expand Your Medical Device Business in South Korea
Are you a medical device manufacturer looking to enter the South Korean market?
Ensure your products meet MFDS regulations and obtain MFDS approval quickly with our expert assistance.
OMC Medical provides end-to-end support for MFDS registration, KGMP compliance, local representation, regulatory documentation, and post-market surveillance, ensuring a smooth and efficient approval process in South Korea
To obtain MFDS (Ministry of Food and Drug Safety) approval for medical devices in South Korea, manufacturers must comply with the following key requirements:
1: Product Classification
- Determine the risk class of your device (Class I, II, III, or IV) based on MFDS guidelines.
2. MFDS Registration
- Submit the required application and documents for medical device approval.
3: Korea GMP (KGMP) Certification
- Manufacturers of Class II, III, and IV devices must comply with KGMP standards to ensure quality and safety
4: Clinical Data Requirements
- Higher-risk devices may require clinical trials or equivalent international clinical data.
5: Local Authorized Representative
- Foreign manufacturers must appoint a Korean Authorized Representative (KAR) to handle regulatory submissions and compliance.
6: Technical Documentation
- Submit essential documents such as test reports, safety evaluations, and labeling requirements
7: Import & Distribution Compliance
- Ensure compliance with South Korean import regulations and post-market surveillance obligations
South Korea’s Ministry of Food and Drug Safety (MFDS) regulates medical devices to ensure safety, efficacy, and quality. The approval process involves five key steps:
Step 1: Appoint a KLH (Korean License Holder)
Your legal representative in South Korea for regulatory submissions.
Ensures compliance with MFDS requirements and local regulations
Step 2: Appoint a K-Agency for K-GMP Audit
- If MDSAP-certified, the audit is conducted virtually.
- Without MDSAP, an on-site audit is required for compliance.
Step 3: MFDS Review (Notification or Technical Audit)
Class I devices undergo a simple notification process.
Class II-IV devices require a detailed MFDS technical audit.
Step 4: MFDS Grants Approval
MFDS reviews and issues the official product approval.
Your device is now authorized for sale in South Korea.
Step 5: Obtain Import Permit & Market Entry
Secure an import permit for customs clearance.
Your medical device is ready for distribution in Korea
Getting difficulty in approval? Must Consult us
Why Register Your Medical Device in South Korea?
South Korea is a rapidly growing market for medical devices, offering:
- Access to the Asia-Pacific Region
- MFDS-Compliant Medical Device Registration
- Competitive Edge in the Healthcare Industry
- Regulatory Compliance & Market Legitimacy
Without proper registration, your product cannot be legally sold in South Korea.
Required Documents for Registration in South Korea
To register medical devices in South Korea, you must submit:
- Device Classification & Technical Documents – Product details and risk classification.
- K-GMP Certification – Compliance with Korean Good Manufacturing Practice
- MFDS Application Form – Official submission to MFDS.
- Test Reports & Clinical Data – Safety and performance evaluation.
- Labeling & Packaging – Korean-language labels and IFU
- KLH Agreement – Legal representation for market entry
Don’t Have These Documents? We Can Help
Who Needs South Korea Medical Device Registration?
- Manufacturers outside South Korea looking to sell medical devices in South Korea
- Distributors & Importers needing regulatory approval for sales.
- Foreign Companies entering the Korean healthcare market
- Healthcare Institutions ensuring compliance with MFDS regulations
Want to Sell in the South Korea?
Product
Registration
Authorized Representative
Product
Classification
Technical
Document
Quality
Assurance
Post-Market Surveillance and Compliance in South Korea
After approval, medical device manufacturers must ensure ongoing compliance with MFDS regulations, including:
- Adverse Event Reporting – Promptly report any device-related incidents.
- Periodic Safety Updates – Submit regular reports on product performance.
- Quality System Compliance – Maintain K-GMP standards for continued approval.
- Labeling & Marketing Compliance – Ensure adherence to MFDS guidelines
- Product Recalls & Corrective Actions – Implement necessary safety measures if required.
Why Choose OMC Medical for South Korea Medical Device Registration?
Navigating the South Korean medical device registration process can be complex, but OMC Medical is here to help. We specialize in MFDS Registration, Product Classification, Local Authorized Representation (KLH), and K-GMP Compliance, ensuring your device meets South Korea’s regulatory requirements. Our expert team also supports Post-Market Surveillance (PMS) and Software as a Medical Device (SaMD) compliance, helping you maintain ongoing regulatory adherence. With a proven track record in the industry, we offer efficient solutions to streamline your approval process.
📌 Book your free consultation today and let us help you navigate the South Korea medical device registration process with ease
Frequently Asked Questions (FAQ)
Still Have Questions? Contact Us Now for a Free Consultation
Yes, a Korea License Holder (KLH) is required to act as your legal representative for regulatory submissions and post-market compliance.
K-GMP (Korea Good Manufacturing Practice) is mandatory for Class II, III, and IV devices. If you have MDSAP, a virtual audit is possible; otherwise, an on-site audit is required
Approval times vary:
Class I: Instant notification
Class II, III, IV: 6 to 12 months depending on MFDS review and K-GMP certification
Certain devices may require additional clinical data or performance testing before MFDS approval.
Yes! OMC Medical provides expert assistance in MFDS Registration, K-GMP Compliance, Local Representation (KLH), and Post-Market Compliance to ensure smooth market entry
Still Have Questions? Contact Us Now for a Free Consultation