South Korea Medical Device Regulatory Strategy Report

The Korean Ministry of Food and Drug Safety (MFDS), formerly known as the Korean Food and Drug Administration (KFDA), regulates medical devices in the country. All medical devices must meet the requirements of South Korea's Medical Devices Act prior to market authorization. Notably, some products that are considered medical devices in other markets are considered under a separate category, Quasi-Drugs, in South Korea.

Manufacturers of Class 2, 3, and 4 devices must receive K-GMP (Korean Good Manufacturing Practices) Certification prior to issuance of the device registration, and renew every 3 years.  Many Class 2, 3, and 4 devices also require supplementary testing to Korean product standards as part of the registration. The device registration route in South Korea will depend on device classification and whether a predicate device exists in the market.

Let Emergo assist you in evaluating the South Korean medical device regulatory framework as it applies to your device(s).

Through our global network of in-house consultants, industry contacts, and regulatory sources, Emergo can provide in-depth analysis of medical device markets, including South Korea.

Our Regulatory Pathway report service on the South Korean medical device market covers the following:

• Regulatory Background on the MFDS
• Product Assessment
• Authorized Representation in South Korea
• Medical Device Registration Requirements
• Labeling and Language Requirements
• Costs and Timeframes
• Regulatory Roadmap for South Korea
• Post-Market Obligations

Please contact us for more information about our Regulatory Strategy Report for South Korea.