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KMID : 1170320080140020143
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Korean Journal of Health Economics and Policy
2008 Volume.14 No. 2 p.143 ~ p.175
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A Study On Distribution System of Pre-Owned Medical Devices
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Park Soon-Mahn
Lee Geun-Chan
Yoo Sun-Kook
Kang Tae-Geon
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Abstract
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Thesedays some advanced countries have required for Korean government to manage remanufactured medical devices as new devices through FTA negotiations. Korean system is different from the system of those advanced countries. Because Korea manages non-new goods as used goods in a lump. Korean regulations for pre-owned medical devices distribution are ambiguous. There is the management regulation only for imported pre-owned medical devices in Korea. However, there isn’t the management regulation for distributed pre-owned medical devices from domestic sources. Therefore, the Korean management regulation for pre-owned medical devices is not symmetric. And the distribution of domestic pre-owned medical devices could be illegal because there is no clear regulation. On the other hand, domestic pre-owned medical devices are distributed implicitly and negatively in actuality. And the safety and quality of those devices could not be guaranteed.
In this paper, we reviewed Korean pre-owned medical devices distribution system and researched other advanced countries systems. Then we derived new policy for the distribution of pre-owned medical devices in Korea. We suggest 2-step choice system before selling pre-owned devices. The one who wants to sell the pre-owned devices must either test the device in a public testing institute or do inspection/consent in the manufacturer or importer of that device. The suggested policy option is thought to have higher benefits but lower cost. Therefore we think that the policy has better acceptance to the stakeholders and higher social benefit.
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KEYWORD
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Pre-Owned Medical Device, Used Device, Distribution Management System
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