의료기기 진입규제의 변화: 공법적 정당화 논거와 규제 방향성

As innovative technologies such as 3D printing technology, patient-specific precision medical care, big data-based healthcare and artificial intelligence are applied to medical devices, significant changes are being made in medical device regulations. Regulatory authorities continue to improve existing medical device regulations to ensure patient choice and promote new industry developments following technological innovation. However, there is anxiety about whether a series of medical device regulation improvement policies are being progressed based on the principle or limit theory. This paper examines the changes in medical device entry regulations by type, finds the justification from the public view, and suggests the direction for regulatory improvement. Under current law, entry restrictions on medical devices are made through licensing procedures through GMP audits, technical documentation reviews, and clinical trial requirements, as well as new medical technology assessments and health insurance coverage determination procedures. Within this basic structure, various aspects of regulatory changes in medical devices can be classified into low-risk digital healthcare devices, in vitro diagnostic medical devices and newly developed medical devices. In order for current medical device regulatory legislation to be constitutionally justified and improved in the desired direction, individual regulatory legislation and regulatory administration must comply with the proportional principle. In addition, even with high public interest mitigation of entry restrictions, the original regulatory objective of ensuring safety should not be retreated. Furthermore, sufficient information should be provided for consumers to accept the residual risks after risk management. In addition, in order to support industrial development and technological innovation, products must be allowed to enter the market as soon as possible. To do this, regulatory standards must be clear and ensure that no regulatory implications make it impossible to enter the market.