• The Journal of Society for e-Business Studies
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• v.25 no.2
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• pp.127-146
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• 2020

Overseas advanced countries are aware of the importance of research equipment and are providing a lot of policy support to revitalize the research equipment industry. However, Korea does not have any law to support policies or related projects to revitalize the research equipment industry. Therefore, there is an urgent need for legislation to support policies and projects for revitalizing research equipment industry. It is considered necessary to establish a separate special law for revitalizing the research equipment industry so that it can gain competitiveness in the global market of the research equipment industry. As we have seen, the necessary articles in the relevant laws should be specified so that various promotion policies can be developed to foster the research equipment industry. In order to promote the development of research equipment industry, there are three essential items to be specified in the law. First is research and development support, second is infrastructure development, and third is business incubation. The following contents should be included in each contents. First of all, "research and development support" includes research and envelopment project promotion and support policy items, research equipment development trends and investment trends, joint research between industry, academia, And research and development support for fusion, hybrid and commercialization. Next, the items to be included in "infrastructure development" should include the establishment of research equipment clusters, related support items, training of professional manpower, and research equipment development base area and institutions. Finally, the items that should be included in "business incubation." include support matters for the development of excellent companies (priority purchase system, etc.), matters related to technology transfer and marketing, matters concerning the protection of intellectual property, And matters for promoting overseas expansion.

• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).