Korea Medical Device and Pharmaceutical Regulations

Korea Medical Device RegulationsThe Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the chief governmental body responsible for overseeing medical device registration, manufacturing, and distribution in South Korea. The MFDS is tasked with establishing standards and specifications for medical products, monitoring pre and post management procedures, ensuring Good Manufacturing Practices (GMP), reinforcing the safety control system, and improving industrial competitiveness of medical products to contribute to the expansion of national profits. Under the MFDS, the Pharmaceutical Safety Bureau, the Medical Device Safety Bureau, the Medical Device Information and Technology Assistance Center (MDITAC), and the National Institute of Food and Drug Safety Evaluation (NIFDS) hold primary responsibility over the review, approval, and regulation of medical device and pharmaceutical products.

Regulatory Approval for Medical Devices in Korea

Current Korea medical device regulations are covered under the Medical Device Act (MDA) that went into effect in 2004. Various amendments and modifications have been made to the MDA since its initial release. The MFDS periodically releases relevant notifications that cover more detailed technical requirements for manufacturers and importers.

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. Class I and some Class II devices require certification by the MDITAC, while new Class II devices, Class III, and Class IV devices require approval by the MFDS.

Companies that wish to manufacture medical devices in Korea must register for a manufacturing business license, and companies that wish to import medical devices into Korea must register for an import business license.

Regulatory Approval for Pharmaceuticals in Korea

Pharmaceuticals in Korea are regulated under South Korea’s Pharmaceutical Affairs Act, and are classified into drug products and pharmaceutical ingredients. Drug products are further categorized into three classifications: new drugs, pharmaceuticals that require data submission, and generic drugs.

New drugs are pharmaceutical materials with a chemical structure or original composition that is completely different from that of any product previously approved in Korea, or a multiple preparation product that contains a new material as an active drug substance. Registration applications for new drugs must include extensive data regarding safety and efficacy, specifications and test methods, Drug Master Files (DMF), Good Manufacturing Practice (GMP), and more.

Pharmaceuticals that require data submission are not new drugs, but still must submit safety and efficacy data for evaluation before receiving approval. This includes drug products that have new effectiveness, composition, route of administration, or other changes.

Generic drugs are products that have the same active ingredient, dosage form, and strength as a new drug (the reference drug). These drugs require the submission of bioequivalence test data and quality data in place of the safety and efficacy data.

Korea’s Good Manufacturing Practice

Medical device manufacturers must comply with Korean Good Manufacturing Practice (KGMP) standards, which 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. KGMP approval is required for all Class II, III, and IV devices before applicants can submit a medical device application. In recent years, KGMP regulations for pharmaceuticals have also become increasingly harmonized with international standards. For more information, please view Quality Management for Medical Products in Korea.

 

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

 

Korea Medical Device and Pharmaceutical Regulatory Resources

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