South Korea KGMP Quality Management System Consulting

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One major step for companies registering medium and high risk medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III and IV medical devices. The MFDS may verify KGMP compliance via onsite inspections conducted either by its own staff or through third-party reviewers.

The Korean KGMP implementation and inspection process

KGMP certification must be secured before you can place any Class II, III and IV medical devices on the South Korean market. In order to obtain KGMP certification, you must submit documentation to an MFDS authorized third party reviewer demonstrating that your device complies with design, risk, technical and related KGMP quality system requirements.

Following submission of your KGMP certification application, your manufacturing site may undergo inspection by a qualified third-party auditor and/or the MFDS depending on your device’s classification:

  • Sites for Class II devices are subject to third-party audits only
  • Sites for Class III and IV devices are subject to a combined audit by a third-party reviewer and the MFDS

Let Emergo Group support your KGMP compliance project

With a well-established presence in Seoul, we provide KGMP implementation and maintenance support to companies inside and outside Korea. We also assist firms prepare for on-site audits to verify KGMP compliance.

Emergo Group consultants offer expert support for all aspects of medical device registration in Korea, including KGMP implementation and maintenance. Our local presence also allows us to act as your Korea License Holder to manage your registration and quality system compliance efforts.

  • Our Seoul office can interact efficiently and effectively with Korean regulators on your behalf
  • We have implemented quality systems for clients in more than 20 countries including South Korea
  • We can manage your KGMP implementation project in parallel with your device registration process
  • If you already have an ISO 13485 quality system in place, we can ensure it meets KGMP requirements as well

Whether your goal is stand-alone KGMP certification or quality system implementation as part of a Korean medical device registration project, we offer expertise to ensure your success.

Please contact us to learn more about Korea Good Manufacturing Practice compliance.

Commonly Asked Questions: 

Is ISO 13485 compliance required in Korea?
Although ISO 13485 is the basis for Korean GMP, an ISO 13485 certificate issued by a European Notified Body or Canadian Registrar will not be accepted as proof of compliance with Korean GMP. You will need to modify your procedures to meet the specific requirements of KGMP.

What are Korean government fees for KGMP certification?
Fees are determined by authorize third party reviewers, but are typically around US$1400 per facility for a paper audit. Should an on-site audit be required an additional U$5,000 to US$10,000 (inclusive of travel expenses) would be incurred.

How long is my KGMP certificate valid?
KGMP certificates must be renewed every three years. The recertification process should be started at least 90 days prior to expiration.