South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning
|Medical Image Analysis Software||Software that can be used for simulation treatment, simulation procedure, and diagnosis by acquiring and analyzing medical images.|
|Radiation Treatment Software||Used to determine radiation simulation treatment and simulation using acquired medical images.|
|Medical Image Detection Aid Software||Assist medical personnel in making better diagnoses by marking them with color or leader lines|
|Medical Image Analysis Device||Device with software that acquires and analyzes medical images and can be used for simulation treatment, simulation procedures, and diagnosis.|
|Medical Image Detection Aid Device||After detecting abnormal areas in a medical image. The device assists medical personnel in making diagnoses by marking them with color or leader lines|
|Medical Imaging Assistance Software||Software used to aid in diagnostic decisions. Uses medical images to determine the presence or absence of a
disease, the severity of the disease, or the degree of likelihood of the condition, etc.
|Medical Imaging Assistance Device||Medical imaging is used to determine the presence or absence of a disease, the severity of the disease, or the degree of likelihood of the condition, etc. is automatically displayed to a device used to aid in making diagnoses.|
Non-Image Analysis AI Software including Wearables
Arguably the fastest growing AI-using medical device segment is wearable devices. A wearable device, like a smart watch, will need to apply under multiple parameters depending on the input method, analysis method, and alert system. For example, a watch that can utilize big data and artificial intelligence to monitor a person’s blood pressure and provide crucial alerts would apply as a patient monitoring device (A26090.01) classified as an item within the examination device (A26000). However, this practice will be updated in the near future as MFDS is planning to release a list of software product types. The public feedback period was closed on September 16, 2020 and the draft list can be found here.
In this example, a wearable blood pressure monitor would be a Class 2 device, requiring 25 working days for a 3rd party to review the technical documentation and 5 working days for the National Institute of Medical Device Safety Information (NIDS) to grant a final approval if it has a predicate. If it doesn’t have a predicate, the application is reviewed by the MFDS for clinical evidence with an official timeline of 80 working days. Manufacturers will also need to submit a valid KGMP certificate as part of either application process.
Importing and Invoicing
Medical device logistics and customs clearance can be a complicated process in Asia. It is important to work with a trusted partner to not only ensure timely delivery of imports but to also maintain compliance and market access. SaMDs add an additional level of complexity as these products are typically sold online and don’t require formal customs clearance. Instead, the Korea Medical Devices Industry Association (KMDIA) requires all manufacturers who sell software downloaded from the cloud or an Appstore, submit reports of the number of downloads or activations. Furthermore, individuals can purchase and download a non-physical SaMD from the Appstore or a website without paying importation taxes.
Examples of AI Products NOT Considered Medical Devices
Not all products using AI sold to healthcare facilities fall under the definition of a Medical Device in Korea.
The following are examples of products not considered a medical device.
- Software that supports administrative affairs of medical institutions (hospital and inventory management, electronic procedures, insurance claim processing, etc.)
- Software for exercise, leisure and daily health management purposes (promote healthy lifestyle, nutritional intake monitoring, etc.)
- Software for educational and research purposes only
- Software for the purpose of managing medical records irrelevant to disease treatment and diagnosis (Electronic Medical Records, Prescription Delivery Systems, etc.)
- Provide medical personnel with tools to organize and track patient health information or treatment information. Software that provides or helps you easily access medical information.
- Software that makes it easy to access medical information related to the patient’s health status or treatment
- Software that searches for standard treatments and clinical literature and summarizes the contents
- Software that searches drug interactions and allergic reactions to prevent drug side effects
Asia Actual is experienced in registering innovative products, including those utilizing AI software, in South Korea and throughout the region.
Please contact Asia Actual if your product uses AI and would like to learn more about the regulatory requirements and market potential, in South Korea and throughout the region.
Even though a product is not classified as a medical device, the product may still be required to adhere to other guidance unrelated to medical devices.