참고문헌
- Health Insurance Review & Assessment Service. 2016 Trends and prospects of therapeutic medical device. Health Insurance Review & Assessment Service 2016.
- Lee KD. Experiences and Tasks of the Medical Device Expert Evaluation Committee. HIRA Policy Trend 2012;6(3):21-31.
- Lee SS, Salole E. Medical Device Reimbursement Coverage and Pricing Rules in Korea: Current Practice and Issues with Access to Innovation. Value In Health 2014;17:476-481. https://doi.org/10.1016/j.jval.2014.03.1719
- Lee CS, Kang GW, Byun SA. Revision Research Report of Relative Value Based Scale. Health Insurance Review & Assessment Service 2006.
- Ministry of Health and Welfare. Reduce outpatient copayment for singlue use syringe and endoscope disinfection. Ministry of Health and Welfare press release. 2016 Nov 4.
- Busse R, Geissler A, Quentin W, Wiley M. Diagnosis-Related Groups in Europe. European Observatory on Health Systems and Policies;2011.
- Lawshe CH. A quantitative approach to content validity. Personnel psychology 1975;28:563-575. https://doi.org/10.1111/j.1744-6570.1975.tb01393.x
- Lee SS, Symonds D, Kamogawa S, Sato M, Chiang E, Salole E. Reimbursement Coverage and Pricing Systems for Single-Use Devices in Asia-Pacific: Japan, Taiwan, Korea, and Australia Compared. Value In Health 2015;6C:126-129.
- Sorenson C, Kanavos P. Financing Medical Devices in France and the UK. European Health Technology Institute on Socio-Economic Research;2014.
- Haute Autorite de Sante. Medical device assessment in France. Haute Autorite de Sante;2009.
- Iglesias CP. Does assessing the value for money of therapeutic medical devices require a flexible approach? Expert Rev. Pharmacoecon. Outcomes Res 2015;15(1):21-32. https://doi.org/10.1586/14737167.2015.982098
- Frigerio M. Getting approval for new therapeutic medical devices versus drugs: are the differences justified? Eur Respir Rev 2016;25:223-226. https://doi.org/10.1183/16000617.0037-2016
- Martelli N, Devaux C, van den Brink H, Pineau J, Prognon P, Borget I. A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty. Plos One 2015;10(12):e0144892. https://doi.org/10.1371/journal.pone.0144892
- Chen W, Yu J, Zhang L, Su G, Wang W, Kwong J, Sun X, Li Y. Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices. Surgery 2018;https://doi.org/10.1016/j.surg.2018.09.010.
- Venkatesh MP, Bandla DT. Regulatory Assessment of Premarket Approval of Medical Devices in US and EU. IJPCR 2017;9(4):281-285.
- FDA. Use of Real-World Evidence to support regulatory decision-making for medical devices. U.S. Department of Health and Human Services Food and Drug Administration; 2017.
- Schnell-Inderst P, Hunger T, Condrads-Frank A, Arvandi M, Siebert U. Recommendations for primary studies evaluating therapeutic medicaldevices were identified and systematically reported through reviewingexisting guidance. J Clin Epidemiol 2018;94:46-58. https://doi.org/10.1016/j.jclinepi.2017.10.007
- NICE. Medical technologies evaluation programme methods guide. National Institute for Health and Care Excellence; 2017.
- HAS. Manufacturer's Guide. Haute Autorite de Sante; 2011.
- Fuchs S, Olberg B, Panteli D, Perleth M, Busse R. HTA of medical devices: Challenges and ideas for the future from a European perspective. Health Policy 2017;121:215-229. https://doi.org/10.1016/j.healthpol.2016.08.010
- Schnell-Inderst P, Hunger T, Condrads-Frank A, Arvandi M, Siebert U. Ten recommendations for assessing the comparative effectiveness oftherapeutic medical devices: a targeted review and adaptation. J Clin Epidemiol 2018;94:97-113. https://doi.org/10.1016/j.jclinepi.2017.09.022
- Zannad F, Garcia MAA, Borer JS, Stough WG, Clutton-Brock T, Rosenberg Y, Packer M. Role of Payers in the Development of Cardiovascular Therapeutics. JACC 2017;70(22):2822-2830. https://doi.org/10.1016/j.jacc.2017.10.027