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New emerging medical device market and its regulations: South Korea

10 August 2010 – The Journal of Medical Device Regulation (JMDR) has published a new, 8 page publication entitled, Medical Device Regulatory Requirements in South Korea.

South Korea is emerging as a prominent medical device market. With a growing gross domestic product, and rising per capita healthcare expenditure, its medical device market can be lucrative for foreign manufacturers. In fact, imports account for the vast majority of the total market. Once the strategy of how to navigate the Korean Food and Drug Administration regulatory scheme has been established, South Korea’s medical device market emerges even more attractive, particularly so for foreign manufacturers. Fortunately, these trends are only forecast to increase.

Topics covered in this publication include:

  • the regulatory authority;
  • the legislative framework;
  • the regulatory controls (classification, requirements for foreign manufacturers, regulatory pathways, manufacturing practices, laboratory testing, timelines and fees);
  • vigilance and post-market surveillance;
  • the labelling and language requirements;
  • the standards organisation; and
  • future prospects.

About Global Regulatory Press

Global Regulatory Press is the London-based publisher of the Journal of Medical Device Regulation (JMDR). The JMDR is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. Full articles are only accessible to subscribers of the JMDR.

For Further Information

For more information on Global Regulatory Press or the JMDR, please contact Marija Capek (tel: +49 (0)176 212 444 26) or visit the Global Regulatory Press website at

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