Abstract: Research aims . The purpose of this research is to develop and validate the Chinese Quality of Life Instrument (ChQOL), a new self-reported health-related quality of life instrument, based on a well established theory on health in Chinese medicine. Methods . This research was carried out two according to major aspects: The first part is to develop and validate the ChQOL (Putonghua version). The development of the ChQOL was based on the health concept in Chinese medicine with a theory driven approach. The first task was to explore the health concept in Chinese medicine and build the conceptual framework of the ChQOL. An expert panel was then invited to comment and give suggestions for improvement of the initial framework. According to their suggestions, the framework was refined and a set of initial items for the ChQOL. The refined framework, together with the key domains, facets and initial items of the ChQOL were then mailed to a sample of about 100 Chinese medicine practitioners throughout Mainland China for their comments and advice. A revised set of items were developed for linguistic testing, by using a convenient sample consisting of both healthy people and patients with chronic illness who attended Chinese medicine treatment. After that, an item pool was developed for field-testing. Field test was conducted in both north and south China on a convenient sample of healthy and patient subjects to determine the construct validity and psychometric properties of the ChQOL including reliability, validity and responsiveness. The second part is to develop and validate the ChQOL (Hong Kong Cantonese version, ChQOL-HK). This is an extended part of the ChQOL studies following the successful development of the Putonghua version. A standard translation procedure was followed. Field test was carried out on a convenient sample of healthy subjects and patients with chronic illness to determine the psychometric properties of the ChQOL-HK in local Chinese medicine clinics of the university with the help of a final year student. Results . Construct validity was established by using various methods, i.e. the internal consistency in all facets and domains were good; the correlation between facets to domain, and domains to overall ChQOL correlation were high; confirmation factor analysis showed that the structure fitness of all facet, domain and overall structure were good with comparative fitness index (CFI) > 0.9. Test-retest reliability was also good, especially in the domain scores with interclass correlation coefficient (ICC) value ranged from 0.83 to 0.90. No ceiling or floor effect was noted which indicated that ChQOL can be applied to subjects with a wide range of health status. Most facet scores, domain scores and the overall ChQOL score were able to discriminate groups of subjects with known differences in health status. Responsiveness study showed that the domain scores could detect changes in quality of life and health status over a period of time. The ChQOL had mild positive convergent with the other generic health related quality of life measures, such as the World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) and the Short Form 36 Health Survey Questionnaire (SF-36), with moderate correlations.