Advances in Neurotechnology and International Standardization of Medical Device Regulations

With the recent growth of the electroceuticals and digital therapeutics industry, licensing, new health technology assessment, and determination of health insurance fees have emerged as important regulatory issues in Korea. Although various neurotechnology-based medical devices have already been released, research on the latest neurolotechnologies such as BCI is underway, and the regulatory standards for them are unclear, as well as the benefits and risks of the technology. As a result, the need for international standardization and global regulatory harmonization will increase, along with the demand for standardization in technical standards, safety verification, and full cycle risk management. This article deals with the characteristics of medical devices to which the latest neurotechnology is applied, its impact on regulation, and related international discussions, as well as the implications of international standards as soft laws, and reviews international standards for medical devices. Based on these discussions, the trend of international standardization of neurotechnology-based medical devices was reviewed and its implications were derived. In order to resolve the uncertainty of regulations on neurotechnology-based medical devices and to regulate them appropriately, flexible responses are needed on the basis of global regulatory harmonization such as international standardization. Additionally, efforts to preempt international standards in neurotechnology-based medical devices are required because international standards are accepted as domestic norms through national standards and directly affect regulations by individual domestic laws. With the rapid development of BCI technology and technology convergence, related industries will grow further in the future, and international discussions on the regulation of neurotechnology will become more active. Through these international discussions, consideration and regulatory principles for the benefits and risks of neurotechnology should be prepared, and they should be embodied through international standards and domestic norms. In this process, regulatory agencies should lead active participation and cooperation of companies and researchers.