융복합 의료제품의 품목허가 지원을 위한 법제도 개선연구 -미국 융복합 의료제품 분류 및 유형을 중심으로-

Combination products refer to products that combine medicines and medical devices. Pre-filled syringes and drug-releasing hydrogel wound dressings are representative product groups that fall under this category. In Korea, laws applicable to medical products are divided into 「Pharmaceutical Act」 which applies to medicines and 「Medical Devices Act」 which applies to medical devices. The definitions of the two laws adopt a mutually exclusive regulation method that excludes each other from the scope of application. However, combination products have the properties of both drugs and medical devices. It is difficult to obtain permission as either a drug or a medical device product group in the licensing process. In order to solve these problems, the Ministry of Food and Drug Safety created a rule called 「Regulations on Complaint Mediation and Handling Procedures for Convergence Medical Products」. The regulatory body handles approvals related to coombination products in accordance with the relevant regulations. But the regulation is nothing more than the Ministry of Food and Drug Safety's task process regulation. Because it is operated in a situation where the delegation clause of the upper law do not exist, it is difficult for a company that manufactures the product to obtain permission. Therefore, in order to manage safely combination products within the legal system, revision of definitions in the Pharmaceutical Act and the Medical Devices Act is required. In this paper, in order to prepare a plan for simultaneous revision of the Pharmaceutical Act and the Medical Devices Act, I will examine the case of the United States, which preemptively regulates to make the laws, regulations, and guidelines related to combination products ahead of Korea. I will investigate specifically what laws and regulations apply to combination products in the US, and derive implications by analyzing how the legal definition and classification standards of combination products are stipulated. In addition, I will consider how to revise our 「Pharmaceutical Act」 and 「Medical Devices Act」 in order to efficiently regulate combinations products.