Medical Device Registration in South Korea
Regulatory submission
Navigating the regulatory landscape for medical devices in South Korea requires a thorough understanding of the unique requirements set by the Ministry of Food and Drug Safety (MFDS). South Korea has established itself as a key global market for medical devices. It has a regulatory system to ensure the safety, effectiveness, and quality of devices introduced into its healthcare ecosystem.
The South Korean regulatory framework adopts a risk-based classification approach, offering different pathways for registration depending on the level of risk associated with the device. Each pathway demands precise documentation and compliance, from simple pre-market notifications for low-risk devices to comprehensive technical file reviews and manufacturing audits for higher-risk categories.
The South Korean system's resemblance to the FDA framework is particularly noteworthy. It includes an easy access route for low-risk devices, a substantial equivalence pathway for moderate-risk devices, and a rigorous pre-market approval process for higher-risk devices. However, South Korea introduced specific requirements, such as Korean Good Manufacturing Practices (KGMP) certification, that go beyond international standards like ISO 13485.
At Qserve, we recognize the complexities of South Korea’s regulatory system and the challenges manufacturers face in meeting these requirements. With our expertise, we simplify the process, ensuring that your devices meet all regulatory standards efficiently and effectively. Whether new to the South Korean market or looking to expand your presence, Qserve is your trusted partner for seamless medical device registration and compliance.
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South Korea Market for Medical Device Manufacturers
South Korea’s Thriving Market
South Korea’s advanced healthcare system, aging population, and focus on innovation make it a prime market for medical device manufacturers. The country’s demand for cutting-edge technologies, driven by a tech-savvy healthcare sector and a thriving medical tourism industry, offers significant growth opportunities.
With a regulatory framework aligned with international standards like the FDA and EU MDR, South Korea provides clear pathways for market entry. Its strategic location also makes it a gateway to the broader Asia-Pacific region.
Expanding into South Korea enhances your global presence and positions your business for long-term success.
Take the first step toward seamless regulatory compliance; contact Qserve today and ensure your medical devices meet all requirements for global market access!
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Expert Regulatory Support for Medical Device Registration in South Korea
Qserve Services for South Korea
- Global Regulatory Strategy: We create a customized roadmap for regulatory compliance that aligns with South Korea’s specific requirements and your global market goals.
- Registration Support: We guide you through the MFDS certification process, from document preparation to submission.
- MFDS Certification: Expert assistance in meeting the MFDS’s requirements for device approval, whether through certification or pre-market approval.
QMS Compliance Support: We perform a detailed gap analysis and prepare you for KGMP audits, ensuring your Quality Management System meets South Korean standards.
- Translation of Labels and IFUs: We ensure your documentation, labels, and Instructions for Use (IFUs) comply with Korean language requirements.
- Conformity Assessment Route Support: Guidance on selecting the most appropriate pathway, certification, or pre-market approval based on your device classification and risk.
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