Mandatory Korea Good Manufacturing Practice (KGMP) Certification for South Korea Device Approval

KGMP Certification: The Quality System Requirement in South Korea

Korea Good Manufacturing Practice (KGMP) certification is a mandatory quality system requirement for foreign manufacturers seeking to register Class II, III, and IV medical devices with the Ministry of Food and Drug Safety (MFDS). KGMP compliance must be demonstrated in addition to, or leveraged through, international standards like ISO 13485.

Application Process and Requirements

The application for a KGMP Certificate must be submitted by the manufacturer's local importer in South Korea. The MFDS then determines the necessary audit scope.

1. Scope: Mandatory for Class II, III, and IV devices. Class I devices are exempt.
2. Audit Type: The MFDS primarily uses two methods:
   • Document Review: The most common pathway for initial and renewal certifications, where the MFDS reviews submitted Quality Management System (QMS) documentation.
   • On-site Inspection: The MFDS conducts a limited number of on-site inspections annually (approximately 20–30), typically reserved for complex or high-risk devices.

Validity and Renewal

The KGMP certification is a time-bound document that must be maintained to keep the device registration valid:

• Validity: The KGMP certificate is valid for a period of three years.
• Renewal: Renewal applications must be submitted prior to expiration and can involve either a document review or an on-site audit, depending on the MFDS's assessment.

Fees and Timeline

Government fees for the KGMP process vary significantly based on the level of audit required. Document audits have a lower associated fee compared to the more costly and time-consuming on-site audits, which are charged based on the number of audit days (e.g., 3-day, 4-day, or 5-day on-site audits).