BSI Japan gains recognition for general and in vitro diagnostic devices


11 April 2005

BSI Japan is pleased to announce that it has gained recognition from the Japanese Government’s Ministry of Health, Labor and Welfare (MHLW) to offer certification services for both general medical and in vitro diagnostic devices. The application process was set in motion on 15 September 2004 in response to the revision of Japan’s Pharmaceutical Affairs Law (PAL) which has now come into effect as from 1 April, 2005.

Under the terms of reference in the MHLW Notice, BSI Japan can assess all categories including 21 controlled medical devices and one designated in vitro diagnostic device.

The Association of Registered Certification Bodies (ARCB) under PAL is comprised of all registered certification bodies which will start full-scale operation to support certification activities in cooperation with the MHLW, independent administrative institutions, industry associations and manufacturers.

BSI Japan, as a member of ARCB, is fully committed to the sound dissemination and development of management practices and third party certification for the medical devices and in vitro diagnostic devices sector.

As such, BSI Japan created a new Product Services Department in January 2005 to ensure the expertise of its service and to cater for the needs of the industry. Upon registration, BSI Japan is in a position to provide comprehensive product certification services for the medical device sector.


For more information please contact:

Lucy Fulton
Public Relations Officer
Tel: +44 (0) 20 8996 7248
Mob: +44 (0) 7717 451 990

For further related information you may also contact:
BSI Japan Product Certification Division at