The regulation of medical devices in the Republic of Armenia. Whether the legislation of the Republic of Armenia complies with the state’s international obligations and international best practices regarding the regulation of medical devices and what are the possible scenarios for legal regulations

Abstract

The term “medical devices” covers a vast range of equipment, from simple tongue depressors to hemodialysis machines. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. Yet many countries worldwide are lacking access to high quality, safe and effective devices and equipment that are appropriate for their specific needs and for healthcare regulation generally. This refers especially to developing countries where health technology assessments are not widespread and where are almost no regulatory controls to prevent the import or the circulation (in particular, the usage and the problems emerged resulting from that) of substandard medical devices. Nowadays, the circulation and sale of counterfeit medical devices, and the misuse and medical errors associated with medical devices especially in healthcare facilities are major concerns in the Republic of Armenia, as in most of the developing countries worldwide. The main reason behind these crucial problems is the absence of supervision in the field of the circulation of medical devices. On the pathway of regulating the market of medical devices in the Republic of Armenia there are a range of legal, social and economic barriers. The current situation of the country in the field of healthcare indicates that national regulatory authorities perform inadequate, focusing mainly on the regulation of medicines and not on medical devices. Historically, the states concentrated on regulating the field of medicines, as it was more or less simple and easy task than the regulation of medical devices (taking into account for example the quantity of medical devices, which is much higher than that of medicines). There is an incomplete domestic legislation on medical devices and lack of specific mechanisms for the regulation of that field. Although the Eurasian Economic Union tries to conduct some measures with the aim of regulating the circulation of medical devices in the region, they still do not play an important and decision-making role internationally, and it is crucial to have domestic regulations and not depend on the regional organization. In addition, regulatory measures do not comply with the international best practices and the International Medical Device Regulators Forum recommendations (even though it is stipulated by the documents of the Eurasian Economic Union), which in its turn can lead to the purchase of medical devices that may do harm and that do not perform according to their intended purpose. Through comparing various international practices and models regarding the regulation of medical devices and drawing parallels between the domestic legislation of the Republic of Armenia and the commitments it is legally bound by under international law, this thesis paper advances to making recommendations for a national strategy and legal framework aimed at regulating the circulation of medical devices.