IMPLEMENTASI KEBIJAKAN ASEAN MEDICAL DEVICE DIRECTIVE DALAM RANGKA MENINGKATKAN KUALITAS ALAT KESEHATAN DALAM NEGERI GUNA MENINGKATKAN POTENSI EKSPOR

NURUL HIDAYATI, NH (2020) IMPLEMENTASI KEBIJAKAN ASEAN MEDICAL DEVICE DIRECTIVE DALAM RANGKA MENINGKATKAN KUALITAS ALAT KESEHATAN DALAM NEGERI GUNA MENINGKATKAN POTENSI EKSPOR. Masters thesis, Universitas Andalas.

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Abstract

The quality of medical devices determines the right medical decision. Carrying out effort to facilitate access towards quality medical devices, Indonesia and ASEAN countries made an agreement, the ASEAN Medical Device Directive. This study is aimed to determine how the implementation of AMDD policies in terms of aspects: size and policy objectives, resources, communication between organizations, attitudes of executors, characteristics of implementing agencies and the environment. This research was conducted using qualitative research methods with data collection techniques in the form of in-depth interviews and document review. Informants in this study are Ministry of Health, Ministry of Trade, Association of Indonesian Medical Device Manufacturers, PT. ABC, PT. XYZ, National Standardization Agency for Indonesia, National Accreditation Committee, Agency for the Assessment and Application of Technology and PT. S-SBU Laboratory. The size and objectives of the AMDD implementation policy have not been achieved to improve the quality and export of domestic medical devices; availability of human resources and financial resources has been optimal, availability of facility resources is not sufficient in terms of reference standards and conformity assessment agencies; the characteristics of the implementing agency have been already running well in terms of the division of responsibilities and implementation of Standard Operating Procedures (SOP); communication between organizations has been carried out but has not targeted all industries; the attitude of the implementing agency has committed to implement AMDD policies and the provision of incentives has affected the attitude of the implementers; the economic and political environment has no effect on AMDD policy.

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