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This thesis addressess key successes and constraints on the implementation ofpolicy adjustment on PBF referring to Ministrial Decree no. 1148/2011 in DKIJakarta and West Java in 2013 using theory of Edward III. Results onsurveillance on PBF in West Java and Jakarta of NADFC in 2012 until 2013, andthe data PBF Licensing of Ministry of Health in 2012 until May 2014, indicatesthat more than 90% PBF did not comply with CDOB, thus not make adjustmentspermission. Research using qualitative methods of content analysis and literaturereview. Results: aspects of competence and commitment to success of theofficers, the availability of instruments and applicable SOPs, coordination amongagencies run well. Obstacles found in several aspects including lack of cleardefinition of permits adjustment, lack of socialization, insufficient number ofofficers, inaccessibility of instruments online basis, and lack of availability ofresources and facilities.Key word: Policy implementation, adjustment policies, PBF, Edward III
The needs of medical devices in Indonesia currently 90% are met by imported medical devices. Therefore the government issued Minister of Health Regulation No. 17 of 2017 concerning Action Plans for the Development of the Pharmaceutical Industry and Medical Devices, one of which is through the policy of accelerating the licensing of medical devices. So this study aims to determine the implementation of accelerated medical device licensing policies to support the development of the domestic medical device industry. This study uses qualitative methods and is analyzed with Van Meter and Van Horn policy theory with variable size and objectives, resources, characteristics of implementing agencies, communication between organizations, disposition of implementers, as well as economic, social, and political environments that influence policy implementation. The results of the study are that the size and objectives of the policy are clear but are still constrained by the availability of human resources and the limited characteristics of the implementing agency, as well as the disposition of implementers that are still less than the intensity of the implementation of the policy. Communication between organizations related to policy is quite optimal, and the economic and social environment is quite supportive, but the political environment is not enough to support policy. This study recommends making accompanying policies such as the obligation to use domestic medical devices at government health service facilities to expand the domestic production of medical devices.
