Medical Device Regulatory Requirements For Malaysia - NEW!

Published 22 Jan 2012

Since 2005 the Medical Device Control Division (MDCD), the responsible authority within the Ministry of Health is aiming at developing a new and comprehensive regulatory framework for Malaysia’s medical device market.

As per today, the Bill has not passed the Parliament yet to become a legal act; therefore, today only a so-called voluntary registration system operates that is called MeDVER (Voluntary Registration Scheme for Medical Devices Establishments). This scheme is a free, web-based program, whose users are all manufactures, importers, exporters, distributor and vendors.

The Medical Devices Act was expected to come into effect at the end of 2011.

Upon advancement, Obelis will inform you about the next stages of Malaysia’s new Medical Devices Act

If you would like to know more about the registration of medical devices in Malaysia, read our PUBLICATION or contact our Representative in Malaysia;

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