• THE INTERNATIONAL COMMERCE & LAW REVIEW
• /
• v.75
• /
• pp.159-177
• /
• 2017

In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

• Korea Journal of Hospital Management
• /
• v.12 no.1
• /
• pp.31-50
• /
• 2007

This study was carried out to analyze the present condition of high-price medical technologies in South Korea and to compare it with OECD countries. This study included 10 high-price medical equipments and used medical equipment registry data of Health Insurance Review Agency. The major findings of this study are as follows; Firstly, The number and growth of high-price medical equipments in South Korea is much higher than those in other OECD countries. There are many of high-price medical equipments even in clinics. Secondly, the percentage of old poor-quality medical equipments is very high, especially in clinics. This is because of high-price of medical equipments. The results of this study implicated that there is high possibility of inappropriate use of high-price medical technologies. This may result in the increase of health expenditure; therefore, there should be a kind of regulation policy to control amount and quality of medical equipment.

• Journal of Biomedical Engineering Research
• /
• v.31 no.2
• /
• pp.129-133
• /
• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Journal of radiological science and technology
• /
• v.41 no.5
• /
• pp.479-485
• /
• 2018

Radiologic technologists working at the second and third medical institutions are classified as radiation-related workers and radiation workers according to their working departments, and are subject to double regulation by the Ministry of Health and Welfare and the Nuclear Safety Commission. We will try to understand the system of dualization and to understand the investigation of recognition. The dualized system of radiation-related workers and radiation workers includes the difference in name and terminology, the effective dose limit, the maintenance education and training of radiologic technologists, the period of medical examination, the radiation zone, dose of the woman whose pregnancy is confirmed in radiologic technologists, the qualification criteria of the safety officer, and the period of the regular inspection of the radiological equipment. In the questionnaire survey on the dualization system, there were various items showing significant differences between the radiation-related workers and radiation workers Overall, the radiation workers were more aware of the radiation workers' education and related terms than the radiation-related workers.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.12 no.1
• /
• pp.413-419
• /
• 2011

Diagnosis X-ray equipment localized at 1950's but it is developed suddenly at 1960's with demand together. Manufacture of Diagnostic X-ray equipment is controled by the KS regulation and the Ministry of Health and Welfare because of hazardous element etc. exposure by radiation. Most of diagnostic X-ray equipment ware single phase and three phase full-wave rectification but from 1980's it transforms it was exchanged in inverter type X-ray equipment. Inverter type X-ray equipment produces approximately 50~80% more average photon intensity then single phase full-wave rectification and the accuracy is high. But from a clinic it dose not use because expensive therefor the efficiency improvement of single phase full-wave rectification is necessary. We produced single phase full-wave rectification X-ray equipment control unit, high tension transformer, filament heating transformer, rectification circuit, high tension cable and others and evaluated efficiency, in result which is excellent compare with Rule of Safety Management and KS regulation.

• Progress in Medical Physics
• /
• v.32 no.4
• /
• pp.83-91
• /
• 2021

Various types of high-precision radiotherapy, such as intensity-modulated radiation therapy (IMRT), tomotherapy (Tomo), and stereotactic body radiation therapy have been available since 1997. After being covered by insurance in 2015, the number of IMRT cases rapidly increased 18-fold from 2011 to 2018 in Korea. IMRT, which uses a high-beam irradiation monitor unit, requires higher shielding conditions than conventional radiation treatments. However, to date, research on the shielding of facilities using IMRT and the current understanding of its status are insufficient, and detailed safety regulation procedures have not been established. This study investigated the recommended criteria for the shielding evaluation of facilities using medical linear accelerators (LINACs), including 1) the current status of safety management regulations and systems in domestic and international facilities using medical LINACs and 2) the current status of the recommended standards for safety management in domestic and international facilities using medical LINACs. It is necessary to develop and introduce a safety management system for facilities using LINACs for clinical applications that is suitable for the domestic medical environment and corresponds to the safety management systems for LINACs used overseas.

• Journal of Service Research and Studies
• /
• v.4 no.2
• /
• pp.1-10
• /
• 2014

According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

• The Korean Society of Law and Medicine
• /
• v.23 no.2
• /
• pp.97-118
• /
• 2022

The use of diagnostic radiation in medical institutions is rapidly increasing. Accordingly, the collective effective dose is on the rise every year. Therefore, it is necessary to reduce the radiation exposure of the person undergoing the radiation examination as low as reasonably achievable. And we must establish a legal system to perform the safe management of radiation for diagnosis efficiently. In this way, I went over the problems of the Act and Subordinate Statutes regarding radiation safety management for diagnosis. As a result, the main contents are as follows. First, in the 「Medical Service Act」, there is no basis for the Safety Inspection Institute of Radiation and Radiation Exposure Measuring Institutes. And there are no provisions concerning delegation of administrative disposition. Therefore, it is necessary to secure legal justification by providing the basis for the Safety Inspection Institute of Radiation along with Radiation Exposure Measuring Institutes and the basis for administrative dispositions against these institutions in the 「Medical Service Act」. Second, the 「Rules on the Installation and Operation of Special Medical Equipment 」 should be integrated with the 「Rules on the Safety Management of Radiation Generators for Diagnostics」 to unify administrative procedures such as reporting for radiation special medical equipment for diagnosis. Third, in the case of violating the diagnostic radiation safety management standards in the 「Rules on the Safety Management of Radiation Generators for Diagnostics」, it is necessary to supplement the insufficient sanctions such as administrative disposition. Fourth, regulating diagnostic radiation and therapeutic radiation used in medical institutions with the dual legal system of the 「Medical Act」 and the 「Nuclear Safety Act」 is not efficient in the safety management of diagnostic radiation. Therefore, it is necessary to uniformly regulate diagnostic radiation and all medical radiation, including therapeutic radiation and nuclear medicine, in the 「Medical Service Act」 system.

• Management & Information Systems Review
• /
• v.1
• /
• pp.413-443
• /
• 1997

In today's hospital-management, information system and the information by it will be a necessary administrative materials of organization with man-power, funds, equipment and resources. This study is for figuring out steps to utilize information-system, an important strategy to grow the hospital applying to the change of surroundings, improving the service for patients, accelerating medical examination, improving it in quality and suggesting a basis be able to manage it effectively by putting information system in practice such as economic effect by shorting time and the effect of medical study by computerizing clinical data. And the result of it is as follows: From the Nolan's 6 step - model about the degree using information system in hospital-management, the 1st group of hospital-size came to 1st and 2nd step, the 2nd group to the 3rd and 4th step and the 3rd group to the 5th and 6th step, which correspond to the survey- results that information system increases with the size of the hospital to propagation, regulation and integration step and that the number of the hospital developing to the step managing information is increasing.

• Journal of radiological science and technology
• /
• v.39 no.4
• /
• pp.651-660
• /
• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.