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Gov't Prepares Medical Device Industry Development Plan   


After selecting 15 strategic medical devices, the government has prepared ways to nurture them, targeting the domestic medical device industry's takeoff toward a global 10th ranking by 2015.

The Ministry of Knowledge Economy (MKE) and Small and Medium Business Administration (SMBA) reported the 'Medical Device Industry Cultivation Plan' to the Crisis Management Countermeasure Meeting held on November 16 at the Gwacheon Government Complex and announced measures to advance the industry and simultaneously foster related SMEs.

The measures came in preparation for the recently expanding trend of the global medical device industry in line with the aging of populations, arrival of the well-being era, increasing demand for medical services in China, etc. The world's medical device industry is growing 6% on annual average and the market for next year is estimated at about US$250 billion.

The government's measures are classified largely into advancement of the medical device industry and cultivation of medical device SMEs.

To advance the industry, the government selected 25 strategic items for investment of 80 billion won by 2015 to pursue joint development and commercialization with enterprises and hospitals. It also plans to promote establishment of large-scale clinical trial database and standardization projects in parallel with technology development of first-class products like ultrasound diagnostic devices and patient monitors.

The government intends to address testing and diagnostic equipment meeting international standards and cultivate 2,500 master and doctorate-degree manpower next year required for R&D, etc.

In response to sharply increasing demand for modernization of health and medical systems from resource-rich and developing countries, the government also decided to prepare measures enabling domestic medical service firms and hospitals to advance abroad in package projects that integrate medical service, medical equipment, hospital construction and hospital management systems by December this year jointly with related ministries.

The government also decided to examine and analyze national and public hospitals' procurement specifications for medical devices and revise them, lest they be narrowly advantageous to specific products in the short term, while resolving discrimination between domestic and foreign enterprises through implementation of quality management inspections identical to those in advanced countries, including the United states and EU.

With regard to cultivation of medical device SMEs, the government decided operate a 'Fast-Track R&D Program' supporting rapid commercialization, from product design to approvals and permissions, for promising medical devices in a bid to strengthen R&D capabilities.

Meanwhile, SMBA and KFDA (Korea Food & Drug Adminstration) also decided to operate 'Medical Devices Development Support Corps' and support expenses required to certify functions and conduct clinical trials and to apply the 'Priority Examination System for the Functions of SME Products' to the medical device field as well.

To support domestic sales channels, the government plans to supplement the system, enhancing the purchasing power of 16 national and public hospitals and raising the ratio of SMEs' related products, which stands at about 1.7%, to the 10% level by 2015.

To accomplish this, the government intends to conduct a joint fact-finding investigation with related ministries in the first half of next year, enhance the efficacy of the public purchasing system and provide an excellent medical device database to national and public hospitals separately through a public purchase information network.

To support exports and pioneering of overseas markets, the government also decided to increase support for SMEs' acquisition of respected overseas certifications to 30 million won from the present 22.4 million won.


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