SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
pharmacists after such stores’ registration with the local government. Medical devices are classified into Classes I to IV, based on their intended use and the risk level associated with the device. Class I devices pre- sent the lowest risk, while Class IV devices are considered the highest risk and are subject to the greatest scrutiny. The Digital Medical Product Act, implemented for digital medical devices and digital integrat- ed drugs as of 24 January 2025, and for digi- tal medical/healthcare support devices, to be implemented as of 24 January 2026, separates digital medical products into the categories of digital medical devices, digital integrated drugs, and digital medical/healthcare support devices. This allows the MFDS to classify digital medical products into different tiers depending on their purpose, function, and potential risk, among other factors. The PAA, the MDA, the Bioethics and Safety Act (BSA) and relevant regulations govern clinical tri- als of medicinal products and medical devices, and the MFDS oversees approval for clinical tri- als. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial To conduct a clinical trial, the relevant clinical trial protocol must be reviewed and approved by an institutional review board (IRB) of the MFDS. The materials required to be submitted by the applicant for clinical trial approval include the following: 2. Clinical Trials 2.1 Regulation of Clinical Trials
• for medicinal products, the clinical trial protocol, development plan, investigator’s brochure, material on manufacturing and quality of the investigational drug, preclini- cal trial data, materials on medical institution conducting the clinical trial, institute analysing the clinical trial sample, and the investigator and Contract Research Organisation (CRO), policies and forms regarding the clinical trial subjects, etc; and • for medical devices, the clinical trial protocol, materials proving that the clinical trial medical device is being manufactured in accordance with the facility, manufacturing and quality management system standards, purpose of use, working principle and technical docu- ments to verify performance and safety. Once approved, clinical trials must be conducted in accordance with the protocol and standards regarding good clinical practice for medicinal products and medical devices, as applicable. 2.3 Public Availability of the Conduct of a Clinical Trial All clinical trials are registered with the MFDS. Basic information regarding clinical trials such as sponsor information, information on the clinical trial including its title, purpose and use, informa- tion of drug used, plan for clinical trial, method to arrange the participants subject to experi- mental group or control group, the status of the clinical trial (eg, on-going, completed), method to administer and evaluate the clinical test (eg, primary and secondary end point), and subject inclusion and exclusion criteria can be searched at the medicinal products comprehensive infor- mation system, which is a website of the MFDS.
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