Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
April 26, 2024
Approximately 5 minutes
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.
- Scope: Mandatory for Class II, III, and IV devices. Class I devices are exempt.
- 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).
Related Articles
Approximately 5 minutes
South Korea Medical Device Registration: MFDS, KGMP, and the Substantial Equivalent Pathway
A guide to South Korea's medical device approval process via the MFDS, outlining the classification system, the requirement for Korean Good Manufacturing Practices (KGMP), and the expedited registration routes based on the existence of a Substantial Equivalent (S.E.).
Approximately 5 minutes
South Korea IVD Registration: Risk Classification and Expedited Third-Party Review
An overview of the South Korean MFDS registration for In-Vitro Diagnostic (IVD) devices, highlighting the GHTF-aligned classification, the role of predicate devices (S.E.) in accessing expedited third-party review for Class II, and the Safety and Efficacy Review (SER) route.
Approximately 5 minutes
South Korea Medical Device Labeling Requirements: MFDS Mandates and Korean Language Rule
Mandatory labeling for medical devices in South Korea is governed by the MFDS Medical Device Act. All labels, including the container and Instructions for Use (IFU), must be in Korean and contain specific identifiers like approval number, product name, and manufacturing data.
Approximately 5 minutes
South Korea Post-Market Surveillance (PMS): Tracking, Vigilance, and Penalties
An overview of South Korea's Post-Market Surveillance (PMS) requirements under the MFDS, covering mandatory tracking devices, adverse event reporting, and the severe administrative sanctions for non-compliance, including fines and license revocation.
Approximately 5 minutes
South Korea License Maintenance: Monthly Supply Reporting and Amendment Requirements
License maintenance in South Korea requires manufacturers to report any license amendments to the MFDS and comply with mandatory monthly supply reports for all device classes (Class IV to I) via the integrated information system, excluding home-use devices.