4 July 2015
Under the Atomic Energy Licencing Act 1984 (Act 304), any medical or dental facility must apply for a Class C licence from the Ministry of Health of Malaysia for the purpose of purchasing, storing, using or transferring (selling) irradiating apparatus such as X-ray machines for medical imaging.
Under the provision of regulation 6(1), Radiation Protection (Licensing) Regulations 1986, a Class C licence is defined as a licence to manufacture, trade in, produce, process, purchase, own, possess, use, transfer, handle, sell or store irradiating apparatus.
All Radiology Departments in the Ministry of Health, i.e. all government general and district hospitals have a valid licence to purchase, store, and use equipment utilizing radiation or radioactive sources. All private centres will also have to apply for and renew this Class C licence if they are to continue providing services.
Performance and safety standards and criteria for diagnostic radiology equipment and associated facilities have been drawn up. For renewal of licence, centres must adhere to these standards of safety and performance. Suppliers of the x-ray unit or any other qualified person approved by the appropriate authority will do the maintenance, periodic servicing and calibration of the x-ray unit.
An audit by a Class H licencee/Consultant is an annual requirement. The approved Class H licencee/Consultant who is appointed by licence holder and approved by appropriate authority will inspect and certify the calibration and maintenance of the x-ray equipment and provide advisory services on the maintenance and operation of the x- ray services.