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p-Index From 2021 - 2026
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All Journal The Medical Journal of Hospital Management and Health Law
H.Sinaga
Universitas Terbuka, Indonesia

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Juridical Analysis of Used Medical Device Import Regulations in Indonesia G.Hutagalung; H.Sinaga
The Medical Journal of Hospital Management and Health Law Vol. 2 No. 2 (2026): The Medical Journal of Hospital Management and Health Law
Publisher : International Medical Journal Corp. Ltd

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.70070/k21j9t58

Abstract

This study examines the legal framework governing the importation of used medical devices in Indonesia, balancing healthcare accessibility with public safety. The introduction highlights the dilemma faced by developing nations regarding cost-effective healthcare solutions versus the risks of substandard medical equipment. The methods utilize a normative legal research approach, analyzing primary and secondary legal sources, including statutory regulations and judicial frameworks. The results indicate that while Indonesian law strictly regulates the import of second-hand goods to protect public health, certain regulatory ambiguities and enforcement gaps persist, particularly regarding exceptions for essential medical technology. The discussion delves into the literature review and comparative legal structures, demonstrating a significant research gap in how specific administrative guidelines align with overarching consumer protection and healthcare laws. It analyzes the tension between economic feasibility for local healthcare providers and the constitutional right to health safety. The conclusions suggest that the current regulatory framework requires harmonization, and the study offers concrete recommendations for legislative updates to establish clearer certification standards and stricter oversight mechanisms.
Co-Authors G.Hutagalung