English

Abstract

The availability of medical devices is a crucial thing for society, considering that health is a basic human need. The society's demand requires an adequate supply of the product. This encourages some businessmen with no good faith to produce and distribute medical devices without fulfilling the standard as determined by the statutory rules. Deviation from the standard is related to the safety standard of the product use, as well as due to the fact that the requirements related to licensing are not met. This will potentially harm society's rights as consumers. This research will analyze the legitimacy of the sales and purchase contract of the medical devices between the producers and distributors when the marketing authorization has not been fulfilled, and the producers’ and distributors’ accountability seen from criminal law and consumer protection law. The research is done by using the normative juridical research method, in which it refers to the prevailing laws and regulations. The research uses the statute approach and conceptual approach. The legal materials used are the primary legal material in the form of laws and regulations and the secondary legal material in the form of legal literature. The data collection technique used is library research. The data is analyzed by applying the deductive way of thinking. Based on the research done, it is found out that the marketing authorization of medical devices is a condition that must be fulfilled by a producer before distributing the product to the consumers. The sale and purchase agreement between the producer and Distributor before the marketing authorization shows that the object in the agreement does not have a lawful cause (containing elements of lawlessness); hence, the agreement is unlawful. Businessmen who violate the rule related to the condition of the marketing authorization of the medical devices will be asked accountable by paying some compensation for the loss suffered by the consumer, and criminal sanctions can be applied to the producer and Distributor, both to individuals and corporations.