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Malaysia will have device legislation by 1998

This article was originally published in Clinica

Executive Summary

The Malaysian government expects to send a medical devices bill to parliament by the end of 1997, enabling new legislation to come into force by mid-1998, coinciding with the full enforcement of the EU Medical Devices Directive. Speaking at a conference on device regulation in Kuala Lumpur on October 23rd, Health Minister Datuk Chua Jui Meng warned that Malaysia needs to have device legislation that is compatible with the EU by June 1998. Otherwise "our medical devices will be excluded from the European market", he said. The EU accounts for 39% of Malaysia's device exports.

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