The Korean medical device market is expected to reach USD 3.8 billion in 2008. One important factor that may slow the market growth rate will be the pricing and reimbursement measures that the Korean government grapples with under its national healthcare system.
Korea depends on advanced medical devices from the U.S., EU, and Japan to supply about 60 percent of total market demand. In 2008, total imports of medical devices were estimated at USD 2.3 billion, with U.S. imports, estimated to be USD 819 million, representing a 34 percent import market share. Market demand for advanced and innovative medical devices in 2008 was estimated to grow slowly due to the significant decline in the exchange rate of the Korean Won vis-à-vis the U.S. dollar and Japanese Yen. Another factor favoring the use of imported advanced medical equipment and devices is the growing number of elderly population and Korean doctors educated in the U.S. and Europe who are accustomed in using advanced medical devices.
The importation of medical devices require the assignment of an importing manufacturer representative or agent to manage medical device approval, post market surveillance and to ensure regulatory compliance. The Government of Korea requires local testing of imported devices for safety and efficacy. In additional to medical device approvals, companies would also negotiate pricing terms with the Korean Health Insurance Reimbursement Agency. The Commercial Section at the U.S. Embassy works closely with associations including Advamed and the U.S. Chamber of Commerce in Korea to ensure U.S. interests are maintained in the medical device industry.
- Cardiovascular products including stents
- Orthopedic implants (Knee prosthesis)
- Ophthalmic lens
- Dental implants
- Soft contact lens
- Surgical laser
- Endo-Laparoscopic equipment
The Korean government is constructing world-class hospitals with 600-800 beds in the Incheon Free Economic Zone (IFEZ). The first hospital at the FEZ is targeted to open in 2013. Since this is the first time that Korea has invited foreign capital participation in healthcare, the development of the Incheon FEZ would provide a good export opportunity for U.S. suppliers of high-end medical equipment and devices.