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Malaysia issues guidance for medical devices

20 August 2013 | Regulatory | By BioSpectrum Bureau

Malaysia's Medical Device Authority (MMDA) guidance addresses certain quality, safety and performance provisions in the country's year-old device regulation

Malaysia's Medical Device Authority (MMDA) guidance addresses certain quality, safety and performance provisions in the country's year-old device regulation

Singapore: Malaysia's Medical Device Authority (MMDA) has issued guidance on good distribution practices for medical devices.

The guidance specify the scope of activities performed by the establishment and the devices it deals with, its outsourced activities, its special storage and handling conditions and other applicable sections of the Medical Device Act 2012 along with the accompanying legislation.

The document, which addresses certain quality, safety and performance provisions in the country's year-old device regulation, applies to authorized representatives of foreign devicemakers, importers and distributors.

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