Description: This session consists of three parts: - Software and medical devices in China and Japan - Emerging medical device cybersecurity regulations in China, Japan and Singapore - Regulatory Framework of Medical Devices using AI in China
Software and medical devices in China and Japan
This session aims to help the participants understand the definition and classification of software as medical devices and other types of software used in the medical devices. The presentation will discuss the relevant regulations, guidelines and examples to illustrate the difference between the software and how they are regulated. The main countries to be covered are China and Japan with a quick comparison of approaches in the EU and US.
Emerging medical device cybersecurity regulations in China, Japan and Singapore
This session presents key aspects of emerging medical device cybersecurity regulations in China, Japan, and Singapore. The innovation of medical devices and their interconnectivity with healthcare systems and the internet has raised concerns over patient safety, data security, and the potential for cyberattacks. To address these issues, global regulatory bodies are implementing cybersecurity regulations. Cybersecurity regulations in the US and EU are still evolving, but they are comprehensive and cover a range of issues related to medical device cybersecurity. Medical device cybersecurity regulations are emerging in China, Japan, and Singapore and cover only limited requirements. The session will enable regulatory affairs professionals to identify and apply key cybersecurity regulations requirements for market authorization in China, Japan and Singapore.
Regulatory Framework of Medical Devices using AI in China
This session will introduce China's regulations for AI medical devices. It will provide insights into the latest guidance and key considerations on AI medical devices from NMPA (National Medical Products Administration), focusing on definitions, classification criteria and lifecycle. Furthermore, topics such as continuous learning and explainability of AI medical devices will be discussed from a practical regulatory standpoint.
Learning Objectives:
- The participant will have the knowledge of definitions and classification rules of software as medical device and software used in medical devices in China and Japan. The participants will have a better understanding of the difference between the two types of software. Although it may differ in each case, the guidance and examples provided would help the participants accessing the products
- The participant will be able to identify medical device cybersecurity requirements for China, Japan and Singapore and how it compares to regulations in the US and EU, as well as the Future developments and implications as it relates to cybersecurity in medical devices.
- The participant will be able to describe the focus of each step in the AI medical device lifecycle according to China’s regulatory framework. The participant will be able to define if a software using AI is an AI Medical Device in China and to determine its risk class. In addition, the participant will be able to describe at least three key considerations when evaluating AI medical devices in China.
