GLOBAL PERSPECTIVES
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Ames Gross
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Korea is an important Asian destination for foreign medical devices. Its total medical device market is about $3 billion. While this may seem low compared with China’s $7.5 billion, Korea’s health expenditure per capita in 2006 was $705 whereas China’s was $61, according to the World Health Organization. This means a greater proportion of the population can afford high-end medical treatment. Also, imported products account for more than 60% of the medical device market.
The Korea Food and Drug Administration (KFDA) is undergoing some reorganization. New divisions of KFDA will include a Risk Prevention Policy Bureau and Risk Violation Central Investigation Agency. The Risk Prevention Policy Bureau will focus more resources on preventing incidents before they occur, while the Risk Violation Central Investigation Agency is designed to strengthen postmarketing surveillance and response. The latter agency will conduct criminal investigations of manufacturers that undertake illegal and unsafe practices in food, drug, and medical device production or distribution.
Several functions previously handled by the KFDA main office, including those of GMP evaluation, will now be taken over by local KFDA offices so that the main office may concentrate on policy and safety. The local offices will be restructured to execute these nationwide tasks. Their simpler duties will be transferred to local governments.
In a move that is likely to ease the way for foreign medical device manufacturers, KFDA is planning to eliminate certain requirements for certificates of product approval. Currently, manufacturers must submit a copy of the product approval from the country of manufacture, the approved technical file, approved type test, and a list of facilities.
Under current law, medical devices manufactured outside of Korea must be approved in their country of manufacture before they can receive product approval in Korea. The manufacturer must submit a valid certificate issued by the government within the last two years. KFDA is taking steps to eliminate this requirement. This change is expected to be implemented by the end of 2009.
While the approved technical file will still be necessary, KFDA also plans to eliminate requirements for a copy of the approved type test and list of manufacturing facilities. The type tests are conducted by a KFDA-registered third-party lab that physically tests samples submitted by the manufacturer. These changes should also be implemented by the end of 2009.
To make the product approval process more efficient, KFDA also recently announced a new risk classification system, which goes into effect July 1, 2009. The current risk classification system has four classes that encompass 1012 classifications:
- Class I, or low risk, contains classifications such as surgical instruments
- Class II, or low-moderate risk, contains classifications such as hypodermic needles
- Class III, high-moderate risk, contains devices such as orthopedic implants
- Class IV, high risk, contains devices such as implantable defibrillators.
The new system will contain approximately 2000 classifications separated into the four risk classes.
Ames Gross, president and founder of Pacific Bridge Medical (PBM), is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, MD&DI (Medical Device and Diagnostic Industry) magazine named Gross one of the top 100 executives in the medical business. Gross founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He is a frequent contributor of articles on Asian medical issues for Clinica (UK), MD&DI (Los Angeles), and other medically oriented journals. Gross has been a featured speaker on the Asian medical markets at the Medical Design & Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society's annual and regional meetings, and a variety of other medically oriented meetings and conferences. Gross holds a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. For more information about PBM, view its listing in the online Consultants Directory or go to the firm's Web site at www.pacificbridgemedical.com.
