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 requirements of South Korea's Medical Devices Act of 2011 prior to market authorization.
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 Global Regulatory Overview 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
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for South Korea
Please contact us for more information about our Regulatory Overview Report for South Korea