ABSTRACT
The opening up of extensive integration together with efforts to simplify administrative procedures and integration in the field of management has created opportunities for people and health workers to have access to technologies, new and modern curative care methods and medical device, thereby reducing risks and adverse impacts on health and the environment. The Ministry of Health has also issued the forms for announcement of eligibility to manufacture, classification, purchase and sale as well as the form of announcement of standards applicable to class A medical device. The Ministry of Health has reviewed the mandatory contents required for medical device and included them in the Decree on goods labelling. The current Decree also contains special provisions for the import and export of medical device and materials for production of medical device containing drugs and precursors.
