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Malaysia warms to medtech regulation with voluntary move:

This article was originally published in Clinica

Executive Summary

Next month, Malaysia should see the first registrations of medical equipment, under an ongoing reform programme. Registration covers all medical devices but will be voluntary until 2007, when the Medical Device Act is scheduled to come into force, making registration mandatory. Malaysia currently has no medical device regulatory authority. Under the new act, the ministry of health will establish a supervisory body with responsibility for registration, enforcement and safety monitoring of all laser and healthcare equipment, reports Pacific Bridge Medical. The act is likely to include international technology standards, pre-market evaluation of high-risk devices, post-market surveillance and adverse event reporting, Clinica understands.

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