• Journal of radiological science and technology
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• v.39 no.2
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• pp.263-271
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• 2016

The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

• Journal of Biomedical Engineering Research
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• v.44 no.3
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• pp.190-203
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• 2023

The purpose of this study is to provide basic data to ensure the safety and essential performance of a Lower Extremity robotic assisted gait training system and to provide advanced technology and technical basis to the industry handling the system. Based on IEC 60601-1:2012/AMD2:2020 (Medical Electrical Equipment - General requirements for basic safety and essential performance of medical electrical equipment), IEC 62366-1:2015/AMD1:2020 (Medical devices - Part 1: Application of usability engineering to medical devices) and EN ISO 14971:2019 (Medical devices - Application of risk management to medical devices), the requirements for ensuring the safety and essential performance of the Lower Extremity robotic assisted gait training system were derived. Through the Delphi survey method and scenario analysis, which reflects the opinions and knowledge of experts in the fields of development, testing and review of technical documents, and quality assurance of medical devices, validity and reliability were conducted and obtained results with adequate content validity ratio (CVR; 0.7≤) and excellent reliability (Cronbach's α; 0.9≤). As a result, it was confirmed that the reliability and validity of the risk management process to ensure the safety and essential performance of the Lower Extremity robotic assisted gait training system are required a model can be established to provide measures to reduce risks according to the level of risk exposure caused by usage.

• Korean Journal of Acupuncture
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• v.40 no.4
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• pp.156-168
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• 2023

Objectives : This study aimed to determine the status of thermal stimulation devices approved in Korea for medical applications over the past 10 years, and based on this, to obtain insight for future thermal treatment in Korean medical institutions. Methods : We searched the item classification list entitled "Regulations on Medical Device Items and Rating by Item" from the Ministry of Food and Drug Safety Notice No. 2021-24, 2021 (Enforced March 19, 2021; www.mfds.go.kr) for individually licensed heaters using the terms "heat" and "heating". Results : We identified 17 items of thermal stimulation product group, of which 1,308 devices were licensed by February 4, 2022, and 53.2% of them (n=696) were devices with valid permits for distribution in Korea. Among the licensed devices, heating pad systems under/overlay (electric, home use) were approved the most, but combinational stimulator (for medical use, home use; Grade 2) accounted for the highest percentage among the current valid permission. Moxibustion apparatuses were licensed separately for electrical use and non-electrical use, and occupied a low percentage of the total devices. We analyzed 307 devices that were accompanied by technical documents and found that the heat sources were wires in 145 (47.2%), infrared rays in 44 (14.3%) and ultrasonic waves in 42 (13.7%) devices. Most (83.1%) devices were used for pain relief, while other applications included beauty, cancer treatment, maintenance of infant body temperature, and healing fractures. Conclusions : Thermal stimulation devices accounted for about 0.9% of all medical devices, and among them, combinational stimulators and heating pad systems under/overlay had the most valid permits. Thermal stimulation devices using heating wires and infrared rays were the most prevalent, and most were used to relieve pain. In order to develop a range of thermal stimulation devices that can be utilized in Korean medical institutions, it is imperative that they have potential applications beyond pain management, addressing various medical purposes. To achieve this, foundational research is necessary to effectively apply diverse heat sources based on medical objectives.

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