Obelis is proud to officially announce the visit of Hirofumi
Koide, distinguished guest and managing director of the Japanese
Association of Clinical Reagents Industries (JACRI) along with
three chairs of the JACRI Committee (Regulatory Affairs,
International Affairs and Social Insurance)
on October 29th, 2007.
As the former general manager of Kyowa Medex, Mr. Koide now
works as the Managing Director of JACRI. JACRI is the voluntary
consensus organization that represents manufacturers and
distributors of IVD Reagents in Japan. Currently there
are 122 companies that are part of JACRI. Mr. Koide and
delegates will be visiting Obelis to discuss the current
IVD regulations, CE Marking and Authorized Representative
situation. They will also be visiting Brussels to
attend the EDMA General Assembly on October 30 and
Obelis is pleased to accept such an honored guest
at its doors and hopes to answer and provide a complete
and current picture of the regulatory situation in the
In fact, Obelis’ mission is to:
- Provide medical device manufacturers with CE
marking, U.S. agent services, and fully integrated business
solutions that enable them to implement the necessary
strategies and tools to remain a competitive force in their
- To enrich the quality of health care by providing
professional services that enhance the availability of medical
devices in the European and U.S. markets.
- To maintain the highest level of quality and standards,
i.e. ISO9000:2000, in all of our business activities.
Please visit www.obelis.net to learn more about our organization
and to receive updates and news about current regulatory issues.