시장진입을 위한 치료재료 신의료기술평가 제도: 의료법, 의료기기법, 국민건강보험법 중심으로

The “New Health Technology Assessment” system for new health technology was first introduced in 2007 in Korea and there have been some gradual changes and improvements. The Health Tech- nology Assessment (HTA) is a process that is being implemented in major countries across Europe as well as Korea through which the safety and effectiveness of new health technology is evaluated using a systematic review methodology. Despite the fact that HTA is focused on assessment of tech- nology, rather than on individual medical devices, treatments are mostly caused by those newly-de- veloped medical devices. Accordingly, even if it’s an assessment on health technology, clinical evi- dence is for medical devices used in this technology. HTA is different from the point of view product approval that verifies safety and effectiveness of the product itself, since it assesses safety and effectiveness on health outcomes when the treatment with a medical device is operated for the patient. However, considering the opinion that the reimbursement application process of medical service for the right of access to health insurance circle needs a long period and has to take compli- cated procedures compared to the product approval by the Ministry of Food and Drug Safety (MFDS), there have been various adjustments to improve the process since 2013. Including the most recently implemented “MFDS product approval-HTA parallel review” system, there are five tracks for HTA as of present. It is essential that the applicant applying for nHTA should review the relevant provisions on the Medical Law, Medical Device Law and National Health Insurance Law for accurate understanding of the system and needs to make an effort to prepare materials suitable for the objective. The purpose of this review is to discuss the purpose and objective of current nHTA in Korea, to review similar process of other countries and to introduce relevant administrative pro- cess according to relevant laws to suggest further necessary improvements of the system.