Guidance Lays Out Good Distribution Practice for Devices in Malaysia

Malaysia’s Medical Device Authority has issued guidance on good distribution practices for medical devices. 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. It does not cover manufacturers and device retailers. The GDP certification should specify the scope of activities performed by the establishment and the devices it deals with; outsourced activities, if applicable; any special storage and handling conditions; and applicable sections of the Medical Device Act 2012 and accompanying legislation.
International Medical Device Regulatory Monitor