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International activity

International Exchange of JACRI

The Japan Association of Clinical Reagents Industries (JACRI) (President: Tetsuya Teramoto) performs exchange with related overseas organizations in countries in North America, Europe and other regions to ensure that In Vitro Diagnostics (IVD) contributes to the medical welfare of people around the world.
Specifically, the International Affairs Committee takes the lead in sharing information and opinions as well as in in performing coordination and collaboration with industrial organization, centered on those in North America and Europe.

Establishment of the International Affairs Committee and Initial Activities
The International Affairs Committee was established in JACRI in 1992. The background of this was changes in the international environment of medical products markets such as globalization in the pharmaceutical related market, harmonization of regulations, implementation of EC directives, and standardization such as ISO. These greatly affected the IVD industry. Also, the committee sent representatives to the Global Medical Device Conference (GMDC), dispatched delegates to overseas academic research organizations such as North American and European public organizations, related companies, inspection centers and health centers, and participated in the Global Harmonization Task Force (GHTF) and ISO/TC212 conferences. These enabled the committee to gather information on overseas markets and information related to regulations and standards in North America and Europe, and perform activities to conform with international standardization and compliance across the entire industry. It also enabled the committee to introduce information from Japan to an international audience, for example by issuing an English version of the “In Vitro Diagnostics Handling Policy”.

Activities with Global Partners
In 2007, JACRI established a working group with the European Diagnostic Manufacturers Association (EDMA), an IVD industrial organization in Europe, and started sharing information directly with EDMA about issues such as market forecasts, pharmaceutical regulations, environmental regulations and methods for raising social awareness of IVD. The Japan Analytical Instruments Manufacturers’ Association (JAIMA) and the US Advanced Medical Technology Association (AdvaMed, and then AdvaMedDx, the association’s clinical testing division) joined to this working group in 2009. This working group has a conference twice a year, in which themes to be discussed were explored and sharing information and collaboration were maintained and expanded. Camara Brasileira de Diagnostico Laboratorial (CBDL) and IVD Australia joined in 2011, and at the 10th working group conference in 2012, the conference was developed into the Global Inter-Association Meeting (GIAM). The meeting tackled themes such as increasing the value of IVD, raising awareness of GIAM, evaluating medical technology, regulation trends and international harmonization. A Canadian organization (MEDEC) also participated. Currently, under the name of the Global Diagnostic Inter-Association Meeting (GDIAM), various activities are being continued with the aim of globalizing JACRI and member companies. Meanwhile, in Asia, a Shanghai seminar was held in 2009 to support JACRI member companies going into the Chinese market. Opinions were exchanged about the current state and issues involved in the entry to the Chinese market. Also JACRI has been supporting the establishment of a China IVD workshop, which are based on activities having seminars.

Further Development as GDA
In October 2014, at the GDIAM held at Chicago, there was a discussion of what activities should be performed to improve the position of IVD. It was decided to establish a single organization to bring together opinions and views to communicate to bodies such as the WHO (One Voice), and to create a website to explain the role and value of IVD and raise awareness of the organization. Also it was decided that the official name of this organization would be the Global Diagnostics Alliance (GDA).
There were also requests for participation from India and South Africa.
With our affiliated organizations, we will continue to discuss the issues that face us and cooperate in order to contribute to the more widespread diffusion of appropriate and useful IVD required by people around the world, as well as fast and accurate testing and the effective management of disease and health.

Introduction of GDA members (PDF)

EU IVD regulation seminar report (PDF)