Japan Association of Clinical Reagents Industries is an organization composed of the enterprises that contribute to medical care and welfare of the nation by developing and manufacturing (importing) in vitro diagnostics for sale to medical institutions primarily through wholesale in Japan and export to the world at large. The Association was established in November 1983 with a membership of 87 companies in the in vitro diagnostics business and has since then consolidated its position and organization in the diagnostics industry. It was conferred corporation status under Minister of Health and Welfare approval in May 1989. The Association, consisting of 121 member companies as of July 2011, has achieved a very important position in the Japanese clinical reagents industry.

The history of this Association dates back to 1965, when the Clinical Reagents Committee of the Pharmaceutical Manufacturers’ Association of Tokyo and its Osaka counterpart began to study the legal place of clinical diagnostics. This discussion has been ongoing in the quest for a clearer definition of these products as drugs within the purview of the Pharmaceutical Affairs Law.

In response to the call for more substantial cohesion of the clinical reagents sector, the members of the industry joined forces in an effort to bring about unification, and an industry-wide majority supporting the creation of a representative organization led to the establishment of the Association.