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Malaysia launches online system for registering IVDs

This article was originally published in Clinica

Executive Summary

Malaysia's Medical Device Authority has added a module for registering in vitro diagnostics to its online, medical device centralized application system, MeDC@St. In addition, the MDA has issued a guidance document that describes the 12 steps involved in submitting an application to register an IVD via MeDC@St. The IVD application form can be accessed via the internet. It must include such things as information on the manufacturer, the common submission dossier template for the IVD, a completed, signed and certified declaration of conformity, and any post-market vigilance history.

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