Core Viewpoint - The definition of "medical devices" is crucial as it delineates industry boundaries, research paths, capital logic, pricing strategies, and even the starting point for industry reshuffling [1][2][4]. Group 1: Definition and Importance - The definition of medical devices affects product marketability, profitability, and industry regulation [2][4]. - Understanding what constitutes a medical device is fundamental for companies to strategize product development and market entry [3][5]. Group 2: Regulatory Implications - Medical AI software must undergo registration and approval processes if classified as medical devices, impacting their commercialization and revenue generation [4][5]. - Medical beauty products face stricter regulations once classified as medical devices, leading to industry consolidation and increased barriers to entry [4][5]. Group 3: Global Perspective - The official definition of medical devices in China is derived from the "Medical Device Supervision and Administration Regulations," emphasizing non-pharmacological efficacy [7][9]. - Globally, while definitions may vary, a common understanding is that medical devices do not achieve their effects through pharmacological, immunological, or metabolic means [9][10]. Group 4: Misconceptions and Clarifications - Not all software qualifies as a medical device; it depends on whether it serves a medical function [12][16]. - Devices used for animal treatment are not classified as medical devices under Chinese regulations, presenting unique challenges for the pet medical equipment market [13][16]. Group 5: Future Directions - Understanding the classification of medical devices is essential for determining project viability, hospital integration, financing, and revenue potential [17]. - The upcoming series "MedTech Base" will explore medical device classification, registration pathways, regulatory systems, and representative products [17][18].