Medical Device Act 2012 s 4
A manufacturer shall ensure that a medical device— (a) conforms to the prescribed essential principles of safety and performance; (b) is manufactured in accordance with good manufacturing practice and any written directive issued by the Authority; and (c) is labelled, packaged and marked in accordance with the prescribed manner.
Obligasi pembuat
Pembuat hendaklah memastikan bahawa sesuatu peranti perubatan— (a) mematuhi prinsip keselamatan dan prestasi yang perlu yang ditetapkan; (b) dibuat mengikut amalan pembuatan yang baik dan apa-apa arahan bertulis yang dikeluarkan oleh Pihak Berkuasa; dan (c) dilabel, dibungkus dan ditandakan mengikut cara yang ditetapkan.
Text as at 1 March 2017 (LOM reprint); amendments made after that date may not be incorporated.
Source: Laws of Malaysia, Attorney General's Chambers of Malaysia (lom.agc.gov.my). Not a copy of the Gazette printed by the Government Printer (Interpretation Acts 1948 and 1967, s 61).