Perlindungan Hukum Terhadap Konsumen Atas Penjualan Alat Kesehatan Yang Tidak Melalui Uji Kelayakan. (Legal Protection Against Consumers Over The Sale of Health Products that are Not Through Due Diligence).

Yannassandi, Muhammad Naufal (2023) Perlindungan Hukum Terhadap Konsumen Atas Penjualan Alat Kesehatan Yang Tidak Melalui Uji Kelayakan. (Legal Protection Against Consumers Over The Sale of Health Products that are Not Through Due Diligence). Undergraduate thesis, Universitas 17 Agustus 1945 Surabaya.

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Abstract

Good medical device products are medical devices that have passed due diligence and distribution permits. With the soaring and increasing need for medical devices, business actors appear to be fraudulent in producing and distributing medicaldevice products. In the market there are still circulation of medical devices that havenot passed due diligence and distribution permits which of course harm consumers so that businesses must be held accountable. The purpose of this research is to identify and explain legal protection for consumers who buy medical devices withoutdue diligence and distribution permits and the responsibility of medical devicemanufacturers who market their products without due diligence and distribution permits. The implementation of standards and quality of medical devices has been stipulated by the minister of health, namely by conducting pre-markets and post- markets that must be carried out and fulfilled by medical device businesses, which must pay attention to safety standards, quality and benefits of products that will be produced and distributed to the public. Business actors who harm consumers as a result of medical devices without going through due diligence and distributionpermits, are responsible for compensation in the form of refunds or replacement of goods and or services of similar or equivalent value, or health care and or provision of compensation in accordance with statutory provisions. applicable. Actions by business actors that harm consumers can be subject to administrative, civil and criminal sanctions. Thus it is concluded that related to legal protection for consumers in the field of medical devices, there is preventive legal protection, namely protection provided by the government with the aim of preventing violations before they occur, which appears in Law No.8/1999, Law No.36/ 2009 and Permenkes No.62/2017, and repressive legal protection in the form of repressive legal protection that can be pursued through litigation and non-litigation channels, and is related to the liability of business actors who harm consumers for medical devices without going through a distribution permit due diligence, business actors fall into product liability liability. Keywords: business actors, consumer protection, medical devices

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