The Role of Standards in Regulation of Nuclear Medicine Devices

Medical devices are products that are directly related to the health of the public. The manufacture, distribution, sale, and aftercare of medical devices are regulated by law. Therefore, medical devices must be manufactured, distributed, sold, and maintained within the scope of the laws and regulations of the country in which they are intended to be used. The International Electrotechnical Commission (IEC) is an international standardization organization that develops standards for the safety of medical devices. The TC 62 subcommittee prepares international standards and other publications that focus on the safety and performance of medical equipment, software, and systems. Countries that dominate the medical device market, such as the United States and Europe, have adopted TC 62 subcommittee standards for medical devices and use them in their regulations. In Korea, the Medical Device Act proves the safety and effectiveness of medical devices and is based on the medical device standards developed by IEC TC 62. For this purpose, medical device developers need to understand regulatory requirements, have the ability to perform verification and certification procedures, and collaborate with regulatory experts to achieve regulatory approval quickly and efficiently. This study aims to identify the requirements for the industrialization of radiation-based medical devices and to identify the standards for regulated medical devices.