ObjectivesTo identify the barriers and facilitators to the successful implementation of imaging-based diagnostic artificial intelligence (AI)-assisted decision-making software in China, using the updated Consolidated Framework for Implementation Research (CFIR) as a theoretical basis to develop strategies that promote effective implementation.DesignThis qualitative study involved semistructured interviews with key stakeholders from both clinical settings and industry. Interview guide development, coding, analysis and reporting of findings were thoroughly informed by the updated CFIR.SettingFour healthcare institutions in Beijing and Shanghai and two vendors of AI-assisted decision-making software for lung nodules detection and diabetic retinopathy screening were selected based on purposive sampling.ParticipantsA total of 23 healthcare practitioners, 6 hospital informatics specialists, 4 hospital administrators and 7 vendors of the selected AI-assisted decision-making software were included in the study.ResultsWithin the 5 CFIR domains, 10 constructs were identified as barriers, 8 as facilitators and 3 as both barriers and facilitators. Major barriers included unsatisfactory clinical performance (Innovation); lack of collaborative network between primary and tertiary hospitals, lack of information security measures and certification (outer setting); suboptimal data quality, misalignment between software functions and goals of healthcare institutions (inner setting); unmet clinical needs (individuals). Key facilitators were strong empirical evidence of effectiveness, improved clinical efficiency (innovation); national guidelines related to AI, deployment of AI software in peer hospitals (outer setting); integration of AI software into existing hospital systems (inner setting) and involvement of clinicians (implementation process).ConclusionsThe study findings contributed to the ongoing exploration of AI integration in healthcare from the perspective of China, emphasising the need for a comprehensive approach considering both innovation-specific factors and the broader organisational and contextual dynamics. As China and other developing countries continue to advance in adopting AI technologies, the derived insights could further inform healthcare practitioners, industry stakeholders and policy-makers, guiding policies and practices that promote the successful implementation of imaging-based diagnostic AI-assisted decision-making software in healthcare for optimal patient care.