What is the KGMP?
K-GMP(Korea Good Manufacturing Practices) certification is a critical requirement for manufacturers of medical devices seeking entry into South Korea’s market. Overseen by the Ministry of Food and Drug Safety (MFDS), this certification ensures that manufacturers comply with quality and safety standards specific to the country. Whether you are a domestic producer or a foreign manufacturer, obtaining K-GMP certification is essential for Class II, III, and IV devices. Here is the guideline on how to prepare KGMP, requirements, and tips to successfully achieve K-GMP certification.
1. What is K-GMP Certification?
K-GMP certification is a quality assurance system based on ISO 13485 but tailored to include additional requirements specific to South Korea. It ensures the consistent production of safe and effective medical devices by setting standards for manufacturing, quality control, and post-market activities.
2. Who Needs K-GMP Certification?
K-GMP is mandatory for:
Class II, III, and IV medical devices.
Foreign manufacturers wishing to export medical devices to South Korea.
Local manufacturers producing regulated medical devices.
Low-risk Class I devices typically do not require K-GMP but must still meet basic regulatory requirements.
Key Steps to Obtain K-GMP Certification?
1. Appoint a Korea License Holder (KLH)
Foreign manufacturers must designate a Korea License Holder (KLH), an authorized local representative, to liaise with MFDS throughout the registration process.
2. Prepare Documentation
The K-GMP application requires detailed technical and quality documentation, including:
Manufacturing processes and facility layout.
Product descriptions and intended use.
Quality control protocols.
Risk management files (aligned with ISO 14971).
Previous ISO 13485 certification (if applicable).
3. Undergo a Facility Audit
MFDS conducts on-site inspections to verify compliance with K-GMP standards. Key areas of focus include:
Hygiene and safety measures.
Production environment and equipment validation.
Documented quality management systems.
Employee training and competency in quality processes.
4. Submit Test Data
For Class II-V devices, manufacturers may need to provide test results for safety and performance according to MFDS standards. This might involve additional local testing if international reports do not meet Korean requirements. This you can find in the technical file you already maintain in regulatory departsments as part of design and development.
5. Post-Market Surveillance Plan
MFDS requires evidence of post-market surveillance capabilities, including adverse event reporting, recalls, and product traceability.
Challenges for acquiring GMP certification
- Language Barriers: All documentation must be submitted in Korean. Foreign manufacturers often need professional translation services.
- Compliance Gaps: Even ISO 13485-certified manufacturers may need to address specific Korean regulations. e.g. Hygine guidance, quality manager requirements
- Timelines: The entire process can take 6–12 months or more, depending on the device’s risk class and completeness of submitted materials. But if you book earlier, you can minimize the timeline.
Conclusion
K-GMP certification is a vital step in bringing medical devices to South Korea, ensuring high standards for safety and quality. By understanding the requirements, preparing thorough documentation, and working closely with an experienced Korea License Holder, manufacturers can navigate the process efficiently. While the journey may be complex, but it's worth it to get in one of Asia’s most advanced medical markets.
Need help with K-GMP certification? Contact a regulatory expert or to us for tailored guidance to simplify the process and achieve compliance faster.