the engineering team , the first requirement is to obtain a clear “ source of authority ” and clear “ obligations ” in the contract in compliance with the Treasury Instruction ( Arahan Perbendaharaan ) and Treasury Circular ( Pekeliling Perbendaharaan Malaysia ).
Besides , the complexity of the diagnostic provision in the radiology department demands the need to understand the various legitimate requirements , as summarised in Figure 2 . This also obliges the segmentation of legislation for each specific necessity that corresponds with accountability and professionalism specified in the “ Professional Engineering Services ” and “ Engineering Works ” milestones . Figure 5 depicts some of the crisscrossing of legitimate requirements with respect to the above entire milestone from day one until the completion :
2 . Medical Device Act 2012 ( Act 737 )
Alongside the device delivery milestone , it has to be noted that Section 5 ( 1 ) of the Medical Device Act 2012 ( Act 737 ) requires a medical device to be registered under the Act before it can be imported , exported or placed in the market . For that reason , an application for medical device registration must be submitted in conformity with Act 737 ’ s requirements and the procedure established by the Authority in Medical Device Regulation 2012 .
Besides , this also applies to medical device usage , disposal and maintenance under their respective Sections . The medical device term covers any product used in healthcare for the diagnosis , prevention , monitoring or treatment of illness or handicap but excludes drugs . The complete definition of medical device is given in Section 2 of Act 737 . The identified Sections under this Act which relate to the project milestone are as shown in Figure 6 .
3 . Atomic Energy Licensing Act 1984 ( Act 304 )
Ionising radiation is used widely in the radiology department , both for diagnosis and treatment . While being tremendously useful , they can be hazardous to patients , staff and members of the public , if not well
Figure 6 : Sections under Act 737 that impose in the device delivery milestone
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