ABSTRACT
It has been five years since TC 249 was established as a new Technical Committee (TC) at the International Organization for Standardization (ISO), specializing in the field of Chinese traditional medicine. In the second Plenary Meeting held in Den Haag (2011), five working groups (WGs) were established within the TC, two of which specialize in standard development of acupuncture needles (WG3) and other medical devices used in traditional medicine (WG4). Japanese delegates have participated in the discussion within these WGs, paying close attention so as to keep the proposals under discussion consistent with existing Japanese standards and certification standards regulated by the Ministry of Health, Labour and Welfare. However, since most of the participants in TC 249 are clinicians or researchers engaged in medical practices, and not experts on domestic/international standards, discussions on harmonization of the submitted projects often become complicated. In this manuscript, four experts (two from academia and two from companies that manufacture acupuncture needles and moxibustion devices) who attended the fourth plenary meeting held in Durban, South Africa, in May 2013, report on the stage of progress of standardization development in WG3and WG4.