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What is Korea Good Manufacturing Practice (K-GMP)
With a population of over 50 million people, South Korea is one of the world's leading economic powers. As the elderly population increases, the country is spending more on healthcare than other Asian countries. South Korea has become increasingly attractive to medical device manufacturers, as over half of the approved medical devices in South Korea are imported from overseas.
Manufacturers and suppliers intending to sell or import medical devices in South Korea must first obtain approval from the Ministry of Food and Drugs Safety (MFDS). Typically, both domestic and foreign manufacturers of imported medical devices are subject to a Good Manufacturing Practice (GMP) audit.
In South Korea, medical devices are categorised into four classes based on their level of risk, and procedures vary according to the class.
Class I: Registration
Class II: Certification
Class III and Class IV: Approval from the MFDS
For medical devices classified as Class II, Class III, and Class IV, including those with new types of technology or new intended uses, the MFDS requires technical documents and clinical studies based on Safety and Efficacy Review (SER).
For Class III and IV medical devices, the MFDS directly reviews the submitted files.
For Class II medical devices, a third-party organisation approved by the MFDS conducts the review on the Ministry’s behalf. Regarding the functionality, safety, and efficacy of medical devices, it is mandatory to obtain test reports from MFDS-approved testing laboratories and submit them.
Manufacturers and suppliers intending to sell or import medical devices in South Korea must first obtain approval from the Ministry of Food and Drugs Safety (MFDS). Typically, both domestic and foreign manufacturers of imported medical devices are subject to a Good Manufacturing Practice (GMP) audit.
In South Korea, medical devices are categorised into four classes based on their level of risk, and procedures vary according to the class.
Class I: Registration
Class II: Certification
Class III and Class IV: Approval from the MFDS
For medical devices classified as Class II, Class III, and Class IV, including those with new types of technology or new intended uses, the MFDS requires technical documents and clinical studies based on Safety and Efficacy Review (SER).
For Class III and IV medical devices, the MFDS directly reviews the submitted files.
For Class II medical devices, a third-party organisation approved by the MFDS conducts the review on the Ministry’s behalf. Regarding the functionality, safety, and efficacy of medical devices, it is mandatory to obtain test reports from MFDS-approved testing laboratories and submit them.
How TÜV SÜD can help you with Korea Good Manufacturing Practice (K-GMP)
Since 1992, TÜV SÜD has been providing services in Korea through its branch offices in Seoul and Busan and testing facilities in Guro-gu, Seoul.
TÜV SÜD Korea is designated as a GMP organisation for medical devices and in vitro diagnostic medical devices by the MFDS in accordance with relevant South Korea medical device regulations.
Our global network of more than 1500 medical professionals are actively involved in medical device standards development activities and are supported by state-of-the-art laboratories.
TÜV SÜD Korea is designated as a GMP organisation for medical devices and in vitro diagnostic medical devices by the MFDS in accordance with relevant South Korea medical device regulations.
Our global network of more than 1500 medical professionals are actively involved in medical device standards development activities and are supported by state-of-the-art laboratories.
What the GMP audit includes
What the GMP audit includes
We conduct the Medical Device GMP Audit to determine whether medical devices can be guaranteed consistently high-quality, ensuring that they are safe, effective, and suitable for their intended purpose.
Scope
- Individuals intending to manufacture medical devices or obtain import approval/certifications/registration for medical devices
- Individuals intending to manufacture or import medical devices for clinical trials
- Medical device manufacturers or importers intending to obtain conformity assessment or conduct a re-certification audit
Types of Audits
- Initial Audit – The audit required to verify the manufacturing facility’s compliance with GMP standards
- Re-certification Audit – Audit conducted every three years in accordance with South Korea medical device regulations set by the Minister of the MFDS regarding compliance with GMP standards
- Change Audit – Audit required to obtain new conformity assessment due to changes in the manufacturing facility’s location
GMP Certification Procedure
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Application Procedure
- ONLY FOR INTERNATIONAL MANUFACTURERS WITHOUT LEGAL ENTITY IN KOREA: Find an importer or distributor in Korea, as only they are authorized to apply for K-GMP.
- Complete the application according to the GMP Application Guideline.
- In compliance with MDFS regulations, all application documents must be completed and submitted in Korean. Our Korean team is available to assist you with this process. Please contact us to schedule a call to discuss the next steps.
- GMP application instructions for medical devices and in vitro diagnostic medical devices
- GMP Application Guideline for Medical Devices and In Vitro Diagnostic Medical Devices (pdf)
- GMP Audit Fees for Medical Devices and In Vitro Diagnostic Medical Devices (pdf)
- Download GMP application and forms for submission
- Download GMP application (hwp format)
- Download GMP submission form (hwp format)
- Download GMP application (word document format)
- Download GMP submission form (word document format)
3. Submit via Integrated Information System for Medical Devices - Medical Device E-Service (allowing applicants to check their status in real-time using the E-Service).
