Guidelines for AI-Based In Vitro Diagnostic Devices in Pathology

“The newly issued Guide-1125-02 outlines the guidelines for the approval and evaluation of artificial intelligence-based in vitro diagnostic medical devices (software) used in organizational pathology. This comprehensive document provides a framework for the regulatory review process, covering definitions, scope, and regulations relevant to AI-based diagnostic tools.

The guidelines detail requirements for application and technical documentation submission, specifying the information needed on product naming, classification, structure, materials, performance, and safety. Key aspects of the guidelines include the sections on manufacturing methods, intended usage, performance, and precautions. It also addresses packaging, storage, and usage periods.

Manufacturers are required to provide technical documentation that includes comparison data with approved products, usage purposes, working principles, performance data, and clinical performance tests. The document emphasizes the importance of detailing the AI models used, such as CNN, RNN, or Random Forest, and methods for image preprocessing and postprocessing.

Performance test reports must adhere to quality control standards equal to or higher than the manufacturer’s own system. Detailed information on the origin or development of the product is necessary, following a structured approach covering the who, what, when, where, why, and how of the development process.

Additional requirements include information on AI model selection, data collection, and the AI learning process. The guidelines also include a checklist to differentiate between guidelines and explanatory materials, focusing on their purpose and content.

For in vitro diagnostic devices imported into the market, the guidelines mandate clear information on the manufacturer and the requester, ensuring compliance with regulatory expectations.”

Source:https://www.mfds.go.kr/brd/m_1060/down.do?brd_id=data0011&seq=15498&data_tp=A&file_seq=2##~https://www.mfds.go.kr/brd/m_1060/view.do?seq=15498&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

Region: South Korea