93/42/EEC (European Medical Devices Directive)

Progress on the Directive:
Significant revisions to the MDD have been published September 2007 via directive 2007-47-EC. This is available on the EU Commission's website at http://europa.eu.int/comm/enterprise/medical_devices/index.htm
This new directive is essentially the first significant modification to the MDD since 1993. It becomes mandatory in March 2010.

Japanese Law 145/87 (Pharmaceutical Affairs Law)

The Japanese PAL has undergone significant revision as of July 2005. Important MHLW Ordinances to consider include 135 (GVP), 136 (GQP), 169 (QMS), 179 (Drug GMP), 36 (GCP), 2 (Buildings and Facilities).