The growing dependence of healthcare systems on advanced medical technologies has transformed the criminal implications of defects in the manufacture and distribution of medical devices into one of the emerging challenges in criminal law and global public health. The international legal framework for the criminalization of medical device–related offences remains fragmented, comprising two distinct yet potentially complementary approaches. The first is the market-regulatory approach of the European Union, which indirectly mandates the imposition of criminal penalties through the Medical Device Regulation (EU) 2017/745. The second is the direct criminal-law approach of the Council of Europe, embodied in the MEDICRIME Convention (2011). Accordingly, this study aims to analyze international criminal policy on liability arising from violations of medical device regulations within the framework of international law, using a descriptive-analytical method. By focusing on Articles 5 and 6 of the EU Medical Device Regulation and Article 113 of the MEDICRIME Convention, the paper concludes that despite significant progress, considerable gaps remain in the regulatory convergence and legislative harmonization between national and supranational systems. It is therefore argued that the combination of stringent regulatory oversight with targeted criminal sanctions represents the most effective strategy to address threats posed by defective and counterfeit medical devices to global health. Accordingly, the Iranian legal system, in addressing emerging threats in the field of healthcare and medical devices, requires fundamental reforms. Transitioning from the current fragmented, inconsistent, and reactive criminal policy toward a comprehensive, preventive, justice-oriented framework grounded in scientific evidence has become an imperative.