• 제목/요약/키워드: Licensing policy

검색결과 102건 처리시간 0.024초

치의학분야 3D 프린팅 기술이 적용된 의료기기의 인·허가전략과 과제 (Licensing strategies and tasks for medical devices utilizing 3D printing technology in dentistry)

  • 신은미;양승민
    • 대한치과의사협회지
    • /
    • 제56권9호
    • /
    • pp.479-490
    • /
    • 2018
  • 3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

  • PDF

Constructing Housing Management Toward Its Professionalization in Korea

  • Lee, Hyunjeong
    • Architectural research
    • /
    • 제16권4호
    • /
    • pp.139-147
    • /
    • 2014
  • The purpose of this study is to explore institutional frameworks to professionalize housing management in Korea. In particular, this research reviews the evolution of professional housing management and its institutional measures in a social constructionist perspective. The main method employed in the study is content analysis in which historical pathways in institutionalization of professional housing management are examined and a wide array of indices from secondary data are drawn out in relation to various actors. The findings show that a series of institutional measures were taken from 1970s to secure the professionalization of housing management ranging from introduction of housing management bylaws, placement of licensed housing managers, legal requirements of professionally managed housing estates, compulsory operation of long-term reserve funds, formation of residents' association, mandatory establishment of long-range maintenance planning, to standardization of multifamily housing management bylaws. Since the Multifamily Housing Management Ordinance of 1979 amended in 1980s, many institutional measures have been legally enforced and shaped contemporary practices of professional housing management such as an association for housing management companies, qualification of on-site housing management agents, national licensing examination for housing managers, an organization for licensed housing mangers, mandatory registration of housing management companies, disclosure of monthly housing management fees, and formalization of public assessment of housing management. In spite of the distinctive marks in the professionalization of housing management, more proactive and competitive approaches to the international professionalization need to be considered.

클러스터 형성을 위한 지식 집약적 IT 부품 연구개발정책의 Dilemma : 공작기계제어 컴퓨터 사례 (The Formation of the Machine Tool Cluster and The Accumlation of Technological Capability of the Numerical Controller Industry in Korea)

  • 임채성
    • 기술경영경제학회:학술대회논문집
    • /
    • 기술경영경제학회 2000년도 제17회 하계학술발표회 논문집
    • /
    • pp.47-64
    • /
    • 2000
  • This paper analyses characteristics of the numerical controller industry in market formation and the Flow of information between users and producers and the characteristic of knowledge base of the industry and discusses the difficulties derived, from the characteristics, in accumulation of technological capability In market formation betweenusers and producers, the multi-layered market is not favorable to domestic producers in that lower end market is not large enough to provide cardle market to them which produce inferior quality and lower price than importer products. The credibility of the permance of a product is difficult to prove until a critical mass of products are sold. Therefore gaining market share is deterred by unproven credibility of the performance of the product. The flow of information between users and producers is limited. The flow of information on users environment through mass market to producers is essential for improving credibility of a product. The nature of knowledge base is tacit and the means of knowledge transmission is limited. Technological licensing and reverse engineering, Which have been conventional industry. These characteristics provide conditions of vicious circle in accumulation of technological capability of the numerical controller industry. This paper argues that these characteristics of the industry challenges existing approach to R&D management and framework of science and technology policy.

  • PDF

일본의 전파관리제도에 대한 조사 (Survey of Japan's Radio Management System)

  • 김성홍;석경휴
    • 한국전자통신학회논문지
    • /
    • 제13권1호
    • /
    • pp.1-8
    • /
    • 2018
  • 현행 무선업무 및 무선국 분류체계의 문제점을 분석하고, 일본의 전파관리 사례를 조사하여 합리적이고 효율적인 전파관리 방안을 마련하는 것이 본 연구의 내용 및 범위이다. 본 연구결과를 전파법 시행령, 무선업무 및 무선국종 분류기준 등에 관한 법제도 제개정 시 기초자료로 활용할 수 있다. 향후 새로운 무선업무/무선국의 정의 및 분류체계에 대한 상세한 해설집을 마련하여 실무에서의 정책 순응도를 높이는 한편, 무선국 허가 검사 업무의 정합성 및 효율성 제고에 기여할 수 있을 것으로 기대된다.

CONSTRUCTION SCHEDULE DELAY RISK ASSESSMENT BY USING COMBINED AHP-RII METHODOLOGY FOR AN INTERNATIONAL NPP PROJECT

  • HOSSEN, MUHAMMED MUFAZZAL;KANG, SUNKOO;KIM, JONGHYUN
    • Nuclear Engineering and Technology
    • /
    • 제47권3호
    • /
    • pp.362-379
    • /
    • 2015
  • In this study, Nuclear Power Plant (NPP) construction schedule delay risk assessment methodology is developed and the construction delay risk is assessed for turnkey international NPP projects. Three levels of delay factors were selected through literature review and discussions with nuclear industry experts. A questionnaire survey was conducted on the basis of an analytic hierarchy process (AHP) and Relative Importance Index (RII) methods and the schedule delay risk is assessed qualitatively and quantitatively by severity and frequency of occurrence of delay factors. This study assigns four main delay factors to the first level: main contractor, utility, regulatory authority, and financial and country factor. The second and the third levels are designed with 12 sub-factors and 32 sub-sub-factors, respectively. This study finds the top five most important sub-sub-factors, which are as follows: policy changes, political instability and public intervention; uncompromising regulatory criteria and licensing documents conflicting with existing regulations; robust design document review procedures; redesign due to errors in design and design changes; and worldwide shortage of qualified and experienced nuclear specific equipment manufacturers. The proposed combined AHP-RII methodology is capable of assessing delay risk effectively and efficiently. Decision makers can apply risk informed decision making to avoid unexpected construction delays of NPPs.

IT 바탕으로 한 ′기술수렴′(Technological Convergence)과 기술추격의 장애: 기계 제어 컴퓨터 사례

  • 임채성
    • 한국기술혁신학회:학술대회논문집
    • /
    • 한국기술혁신학회 2001년도 춘계학술대회:발표자료
    • /
    • pp.411-430
    • /
    • 2001
  • This Paper analyses characteristics of the numerical controller industry in market formation and the flow of information between users and producers and the characteristic of knowledge base of the industry and discusses the difficulties derived, from the characteristics, in accumulation of technological capability In market formation between users and producers, the multi-layered market is not favorable to domestic producers in that lower end market is not large enough to provide cradle market to them which produce inferior quality and lower price than imported products. The credibility of the performance of a product is difficult to prove until a critical mass of products are sold. Therefore gaining market share is deterred by unproven credibility of the performance of the product. The flow of information between users and producers is limited. The flow of information on users environment through mass market to producers is essential for improving credibility of a product. The nature of knowledge base is tacit and the means of knowledge transmission is limited. Technological licensing and reverse engineering, which have been conventional means of knowledge transmission, are not useful in the numerical controller industry. These characteristics provide conditions of vicious circle in accumulation of technological capability of the numerical controller industry. It is conjectured that these characteristics are derived from the fact that the numerical controller is the result of IT based technological convergence in controlling machining process. This paper argues that these characteristics of the industry challenges existing approach to R&D management and framework of science and technology Policy.

  • PDF

Injunctions and Hold-up under Weak Patent Protection

  • SIM, KYOUNGBO
    • KDI Journal of Economic Policy
    • /
    • 제42권2호
    • /
    • pp.1-30
    • /
    • 2020
  • This paper analyzes how injunctions relate to patent hold-up problems. To this end, we present a simple model of licensing negotiations between a patent holder and a downstream firm in the shadow of litigation. More specifically, we consider the situation in which an injunction is granted as a matter of course if a patent is found valid and infringed upon in litigation, but the patent holder may be under-compensated due to aspects of the patent remedy system other than injunctions. We show that if the downstream user is unaware of the patent before any investment in initially designing its product, the patent hold-up problems created by injunction threats are worrisome when (i) the redesign process is costly, (ii) the degree of patent protection (by aspects of the patent remedy system other than injunctions) is sufficiently strong and (iii) the injunction is requested not to practice the patented technology exclusively but to collect excessive patent royalties. Even if the downstream user is aware of the patent before the initial investment, the patent hold-up problems do not disappear. The findings here imply that a discretionary approach is required towards denying injunctions against patent infringement. If the degree of patent protection is not sufficiently strong, denying injunctions can exacerbate the under-compensation problem. However, once patent protection improves enough (not necessarily perfectly), we may see a surge of patent hold-up problems, and it would be better to apply alternative patent remedies in place of injunctions when necessary. Lastly, we discuss several possible alternatives to injunctions and their pros and cons.

호주의 보완의학 현황에 관한 연구 (A Study on the Current Status of Complementary Medicine in Australia)

  • 고요한;임병묵
    • 대한예방한의학회지
    • /
    • 제28권1호
    • /
    • pp.13-30
    • /
    • 2024
  • Objectives : This study aimed to investigate the history, current status, and regulation of complementary medicine in Australia. Methods : To investigate complementary medicine in Australia, we searched domestic and overseas academic databases, and websites of public and private organizations related to the Australian health care. Results : Complementary medicine consists of numerous services, among which massage and chiropractic care are significantly utilized by Australians. Since 2010, Australian healthcare practitioners, in the field of complementary medicine, have been supervised by the Australian Health Practitioner Regulation Agency (AHPRA). Those who AHPRA is responsible for managing acupuncturists, chiropractors, and osteopaths. Other professions are regulated by their own respective associations. Not only aforementioned services offered by specialists, but also consumption of oral supplements accounts for considerable portion of complementary medicine in Australia. Complementary medicine products, vitamins, and minerals are managed by the Therapeutic Goods Administration (TGA). In terms of insurance policy, the reimbursement of complementary medicine expenses in Australia is covered by the public healthcare insurance system, Medicare. Medicare covers acupuncture, chiropractic, and osteopathy services. Other complementary therapies are continuously reviewed to update their coverage under this scheme. Conclusion : In Australia, practitioner qualifications, education standards, and scope of procedures related to complementary medicine are systematically managed through legal regulations of the federal and state governments.

우주개발진흥법의 적용과 실제 (Space Exploitation Act : Its Implication and Application)

  • 신홍균
    • 항공우주정책ㆍ법학회지
    • /
    • 제20권2호
    • /
    • pp.277-292
    • /
    • 2005
  • 우주개발진흥법은 동 법령의 목적, 및 그 주요 개념 규정에 있어서 항공우주산업개발 촉진법과의 구별야 확연하도록 도모하고 있으며, "우주개발"의 개념을 새로이 규정하면서 이를 꾀하고 있다. 규정된 개념의 특징은 우주공간을 탐사하고 이용하는 각종행위는 인공위성 및 발사체 등과 같이 우주 환경에서 사용되기 위한 기기와 장비의 기술 개발에 의해서만 가능한 것이기에 우주공간의 탐사와 이용은 그러한 기술개발을 포함하는 개념으로 보아야 한다는 데에 있다. 이에 동법이 추구하는 우주개발은 "우주산업"과는 구분되는 것이기에 법령 체계와의 조화 문제가 극복되고 있다고 볼 수 있다. 아울러 우주개발진흥볍은 국제협약상의 의무를 이행하면서, 아울러 최소한의 규제에 의해서 필요한 목적을 달성하기 위한 방식을 택하고 있다. 즉, 우주물체의 등록제도, 국내에서의 발사 허가제도 등을 통해서 우주활동에 대한 규제를 꾀하고 있다.

  • PDF

대학(대학원) 졸업 후 의사 수련교육 거버넌스 고찰 (Review the Governance of Graduate Medical Education)

  • 박혜경;박윤형
    • 보건행정학회지
    • /
    • 제29권4호
    • /
    • pp.394-398
    • /
    • 2019
  • Education on the physician continues with undergraduate medical education, graduate medical education, and continuous medical education. The countries such as the United States, Japan, the United Kingdom, German, and others are required to undergo training in the clinical field for 2 years after completing the national medical examination, and to become doctors after passing the clinical practice license test. Korea can obtain a medical license and become a clinical doctor at the same time if it passes written and practical tests after completing 6 years of undergraduate medical education or 4 years of graduate school. About 90% of medical school graduates replace clinical practice with 4-5 years of training to acquire professional qualifications, but this is an option for individual doctors rather than an extension of the licensing system under law. The medical professional qualification system is implemented by the Ministry of Health and Welfare on the regulation. In fact, under the supervision of the government, the Korean Hospital Association, the Korean Medical Association, and the Korean Academy of Medical Sciences progress most procedures. After training and becoming a specialist, the only thing that is given to a specialist is the right to mark him or her as a specialist in marking a medical institution and advertising. The government's guidelines for professional training are too restrictive, such as the recruitment method of residents, annual training courses of residents, dispatch rule of the residents, and the quota of residents of training hospitals. Although professional training systems are operated in the United States, the United Kingdom, France, and Germany, most of them are organized and operated by public professional organizations and widely recognize the autonomy of academic institutions and hospitals. Korea should also introduce a compulsory education system after graduating from medical education and organize and initiate by autonomic public professional organization that meets global standards.