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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. As of September of 2013 no Class I devices require KGMP certification. The MFDS may verify KGMP compliance via onsite inspections conducted either by its own staff or through third-party reviewers.
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:
With a well-established local presence in Seoul, Emergo Group provides KGMP implementation and maintenance support. We also assist firms prepare for on-site audits to verify KGMP compliance.
Emergo Group consultants in Seoul offer expert support for all aspects of medical device registration in Korea, including KGMP implementation and maintenance. Our local presence in South Korea also allows us to act as your Korea License Holder to manage your registration and quality system compliance efforts.
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.
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.