This study analyzes the harmonization of regulation of distribution and product traceability (tracing) of medical devices as a preventive effort to prevent counterfeit goods, integrated distribution and traceability, and law enforcement mechanisms to fulfill consumer rights guaranteed by the UUPK. The type of research used is normative legal research with a legislative approach and a conceptual approach. The legal materials used are primary, secondary, and tertiary legal materials. The technique of taking legal materials uses a literature study with the technique of analyzing legal materials is compiled and analyzed qualitatively prescriptively, then the data is described descriptively. Based on the results of the research, the regulation of distribution and traceability of medical devices has not met legal principles in fulfilling consumer rights in the digital era, as evidenced by the soaring number of crimes of counterfeiting permits, medical device products, and recycling of medical devices. Harmonization is needed by reconstructing the distribution and traceability arrangements of medical devices in Indonesia based on adoption from other countries that provide certainty and protection for consumers. The recommendation to reconstruct the law by adopting device traceability arrangements through the Unique Device Identification (UDI) system is expected to substantially increase the effectiveness of consumer protection guarantees.
