South Korea KGMP Quality Management System Consulting

ANSWERED ON THIS PAGE:

• What is the quality system requirement for device companies in South Korea?
• Will ISO 13485 certification satisfy Korean QMS requirements?
• What is involved in the Korean KGMP certification process?

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 will verify KGMP compliance via onsite inspections, conducted either by its own staff or with the assistance of a Third Party Auditor.

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

The Korean KGMP implementation and inspection process

KGMP certification is required before you can place any Class II, III, and IV medical devices on the South Korean market. To obtain KGMP certification, you must submit documentation to an MFDS authorized third party auditor, 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 will likely 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

In case another Korea License Holder holds a valid KGMP certificate with the same manufacturer’s information and product category, a new Korea License Holder likely requires only a desktop audit performed for that same manufacturer.

Let Emergo support your KGMP compliance project

Emergo 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
• If you already have an ISO 13485 quality system in place, we can perform a gap analysis to ensure it meets KGMP requirements as well

We offer the expertise to support your success in obtaining KGMP certification as part of your Korean medical device registration project.

Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a demo so you can explore a software solution that connects with your processes, people, and data.

Common Korean GMP questions

Is ISO 13485 compliance required in Korea?
Although ISO 13485:2016 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.

How long is my KGMP certificate valid?
KGMP certificates must be renewed every three years. The renewal KGMP application must be submitted by 90 days prior to expiration to third-party audits at the latest.

How long does it take to obtain KGMP certification?

If timed well, the KGMP inspection will only add an additional one to two months to the overall process, assuming no findings that need to be addressed post-audit. If there are non-conformances which must be resolved, an additional three to four months may be added to the timeline.