• 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.

• The Korean Journal of Air & Space Law and Policy
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• v.33 no.2
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• pp.315-343
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• 2018

In the event of an air accident, the media and members of the general public pay attention to the victim of the accident and are deeply concerned about their actions and rewards. However, through the accident of Air China(CCA) Flight 129, which occurred in 2002, we were able to confirm that it is a real problem that the victims of the air accident as well as the victims suffer much suffering and serious aftermath. Nevertheless, Korea's system for assistance the families of victims of air accident is very poor. On the other hand, when Trans-World Airlines(TWA) Flight 800 exploded and crashed over the Atlantic Ocean in 1996, the United States enacted a law to assistance the families of the victims of the accident. According to this law, systematic assistance and management of not only the victims of the accident but also their families, minimize the additional damage of victims and victims' families and help them to get rid of the accident after the accident. In particular, the measures taken by the US authorities in response to an accident in which an Asiana Airlines flight(AAR) 214 crashed during a landing at San Francisco International Airport in 2013, made a lot of suggestions for us to assistance the victims and their families in an air accident. The purpose of this paper is to suggest the necessity of improving the system for victims and victim's family assistance in air accident. In this paper, we analyze the domestic and foreign legal systems and related cases in past accidents, identify the deficiencies of the Korean system, and derive the necessity to improve the related system. It is also important to make sure that victims' families are relieved from early psychological and economic shocks and that the results of accident investigations are reliable. Relevant ministries, airlines, and related agencies should recognize that prompt and systematic assistance and cooperation is needed to ensure that victims and families are relieved of the impact and confidence in the investigation, as is the case in the United States. In addition, efforts should be made to supplement the related laws for the assistance of aircraft victims and victims' families, to establish manuals for implementation, to plan and to implement them promptly in the event of an accident. To achieve this, it is necessary to establish regulations for the legal institutionalization of the roles and responsibilities of national and state agencies on victims of aviation accidents and family assistance. And the victim and family assistance plan that the airline has to submit to it, as specified in the current law, need to specify that item. In addition, new and supplemented contents should be integrated into a single clause or proposed as a separate special law for the purpose of applying a clear law.