• Journal of Technology Innovation
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• v.28 no.4
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• pp.1-26
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• 2020

Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

• Journal of Food Hygiene and Safety
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• v.32 no.3
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• pp.179-186
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• 2017

For more efficient and proactive safety control of imported food, new trend in U.S. is emerging, which assesses the food safety control systems of exporting countries using Systems Recognition Assessment Tool and helps ensure safety of imported foods. This study examines trends in development and application of assessmemnt tool and country assessment reports in U.S. where an active discussion on this issue is in progress. The expert interviews were also conducted. U.S. Systems Recognition Assessment Tool was developed by FDA to recognize the potential value in leveraging the expertise of foreign food safety systems and help ensure safety of imported food. The tool is comprised of ten standards and provides an objective framework for determining the robustness of trading partners' overall food safety systems. Using its own tool, the U.S. FDA conducted a preliminary assessment of the food safety control systems of New Zealand and Canada. According to the U.S.-New Zealand and the U.S.-Canada assessment reports, the overall structure of the systems was similar between the countries. In summarizing the opinions of experts, such a trend in National Food Safety Control System Assessment may be utilized in the sanitary assessment and the control of imported food border inspection frequency before importing food. It would contribute to more effective distribution of national budget and increased public trust. Additionally, international collaboration as well as securing of qualified experts and sufficient budget appear to be crucial to further increase the utility of National Food Safety Control Systems Assessment. In conclusion, firstly, it is critically important for the competent authority of South Korea to proactively respond to international trend in National Food Safety Control System Assessment by identifying the details of its background, assessment purpose, core assessment elements, and assessment procedures. Secondly, it is necessary to identify and complement the weaknesses of Korea's food safety control system by reviewing it with U.S. Systems Recognition Assessment Tool. Thirdly, by adapting the assessment results from imported countries' food safety control systems to the imported food inspection intensity, the resources previously used in inspecting the imported food from accredited countries can be redistributed to inspecting the imported food from unaccredited countries, and it would contribute to more efficient imported food safety control. Fourthly, the competent authority of South Korea should also consider developing its own assessment tool designed to reflect the unique characteristics of its food safety control system and international guidelines.

• Journal of Food Hygiene and Safety
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• v.30 no.1
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• pp.13-27
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• 2015

A systemic review on the factors affecting food catering hygiene was conducted to provide information for risk management of food catering in Korea. In total 47 keywords relating to food catering and food hygiene were searched for published journals in the DBpia for the last decade (2005-2014). As a result, 1,178 published papers were searched and 142 articles were collected by the expert review. To find the major factors affecting food catering and microbial safety, an analysis based on organization and stakeholder were conducted. School catering (64 papers) was a major target rather than industry (5 pagers) or hospitals (3 papers) in the selected articles. The factors affecting school catering were "system/facility/equipment (15 papers)", "hygiene education (12 papers)", "production/delivery company (6 papers)", food materials (4 papers)" and "any combination of the above factors (9 papers)". The major problems are follow. 1) The problems of "system/facility/equipment" were improper space division/separation, lack of mass cooking utensil, lack of hygiene control equipment, difficulty in temperature and humidity control, and lack of cooperation in the HACCP team (dietitian's position), poor hygienic classroom in the case of class dining (students'), hard workload/intensity of labor, poor condition of cook's safety (cook's) and lack of parents' monitoring activity (parents'). 2) The problem of "hygiene education' were related to formal and perfunctory hygiene education, lack of HACCP education, lack of compliance of hygiene practice (cook's), lack of personal hygiene education and little effect of education (students'). 3) The problems of "production/delivery company" were related to hygiene of delivery truck and temperature control, hygiene of employee in the supplying company and control of non-accredited HACCP company. 4) The area of "food materials" cited were distrust of safety regarding to raw materials, fresh cut produces, and pre-treated food materials. 5) In addition, job stability/the salary can affect the occupational satisfaction and job commitment. And job stress can affect the performance and the hygiene practice. It is necessary for the government to allocate budget for facility and equipment, conduct field survey, improve hygiene training program and inspection, prepare certification system, improve working condition of employees, and introducing hygiene and layout consulting by experts. The results from this study can be used to prepare education programs and develop technology for improving food catering hygiene and providing information.