<![CDATA[Medical devices are an essential component of modern healthcare that directly impact patient safety. The increasing use of medical devices in healthcare facilities in Indonesia raises legal issues regarding the liability of business actors when patients suffer losses due to defective or malfunctioning medical devices. This study aims to analyze the legal liability of medical device business actors for patient safety based on the applicable laws and regulations in Indonesia, as well as to identify obstacles and efforts in law enforcement. This study uses a normative juridical approach with a statute approach and a conceptual approach. The findings show that the legal liability of medical device business actors encompasses fault-based liability, strict liability, and product liability under Law Number 8 of 1999 concerning Consumer Protection, Law Number 17 of 2023 concerning Health, and Government Regulation Number 28 of 2024 concerning the Implementation of Law Number 17 of 2023 concerning Health. Law enforcement remains constrained by weak post-market surveillance, limited incident reporting, insufficient supervisory resources, complex distribution chains, technological developments, and low legal awareness among business actors. Strengthening integrated materiovigilance, supervisory capacity, responsive regulations, and regulatory education is necessary to ensure effective patient safety protection.]]>
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