Background: Near-misses are errors that have the potential to cause an adverse event but fail to do so because of chance or because they are intercepted. By 2021, Sri Lanka had only established systems for maternal and blood transfusion services. Methods: A new, holistic near-miss reporting system was developed and piloted at a large tertiary hospital in 2022 to guide subsequent nationwide implementation. During the pre-interventional phase, national-level consultative meetings (n=20), key informant interviews (n=10) and focus groups (n=22) were convened with purposively selected representatives of professional colleges, academia, medical administrators, and senior staff of the participating hospital to identify existing methods of reporting near-misses. A near-miss reporting format and guidelines were designed with input from national-level consultative meetings. Training on the new system for medical and nursing officers, periodic reminders to staff, and dissemination of preventive measures for patient safety incidents were implemented as interventions. A pre-post evaluation was conducted to identify the effect of the new system, and stakeholders’ views on potential for nationwide implementation. Results: Eight near-misses were reported three months following implementation, compared to none prior to implementation. Study participants expressed satisfaction with the new system’s user-friendliness, clarity, non-punitiveness, voluntary nature, and confidentiality protection. The system was perceived to be suitable for national implementation following refinements. Conclusions: This evidence-based near-miss reporting system, combined with the complementary activities implemented in the pilot setting, should now be introduced into additional hospitals before national implementation to further enhance its design, support from stakeholders, and quality and safety impact.