Korea Medical Device Regulations

Korea Medical Device RegulationsThe South Korean Ministry of Food and Drug Safety (MFDS) is the chief governmental body responsible for overseeing medical device registration, manufacturing, and distribution. The MFDS is tasked with establishing standards and specifications for medical devices, monitoring pre and post management procedures, ensuring Good Manufacturing Practices (GMP), reinforcing the safety control system, and improving industrial competitiveness of medical devices to contribute to the expansion of national profits. While the MFDS is the primary regulatory body, other governmental organizations that influence Korea medical device regulations include the Ministry of Health and Welfare, the Medical Device Safety Bureau, and the Korean Food and Drug Administration.

Medical Devices Safety Bureau

The Medical Devices Safety Bureau houses a number of divisions that are responsible for specific monitoring, policy, and regulatory tasks. The Medical Devices Evaluation Department is the paramount decision making body within the bureau. Medical Devices are divided into three separate categories under the Safety Bureau: Diagnostic, Therapeutic, and Medical Materials and Supplies.

There are also three separate divisions responsible for various aspects of medical device laws. These divisions are the Policy Division, Management Division, and Quality Division. The Medical Devices Safety Bureau has also designated two separate “task forces” for dealing with priority issues. The Approval-Review Coordinating Task Force and the In-Vitro Diagnostics Task Force work to expedite the approval process for medical devices.

Medical Device Act

Current Korea medical device regulations are covered under South Korea’s Medical Device Act (MDA) that went into effect on May 30, 2004. The MDA is a broad set of laws and regulations that covers medical devices. Various amendments and modifications have been made to the MDA since its initial release. The Korean Food and Drug Administration periodically releases relevant notifications that cover more detailed technical requirements for manufacturers and importers.

Korea’s Good Manufacturing Practice

Under Korean law, medical device manufacturers must comply with Korea’s Good Manufacturing Practice (GMP). GMP approval is required for all Class II, III, and IV devices. Beginning in January 2016, applicants must submit to a GMP audit and earn certification before submitting a medical device application.

Korea’s GMP standards cover manufacturing processes such as production standards, quality assurance, hygiene control, storage maintenance, and training procedures. The MFDS verifies that manufacturers meet these specifications by conducting on-site inspections.

Classification System

Under Korean regulations, devices are classified to Class I, II, III, and IV depending on their risk level. Class I devices pose little risk to patients while Class IV devices are high risk, complex devices. Foreign companies must appoint a Korea License Holder if they are interested in registering a medical device in Korea.

 

For more detailed information about regulatory process and registration pathway for medical devices in Korea, please see Medical Device Registration in Korea.

 

Korea Medical Device Regulatory Resources

Medical Device Regulatory News from Korea

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