78GLOBAL REGULATIONS ON THE APPROVALS, MANUFACTURER AND MARKETING OF MEDICAL DEVICES IN REGULATED COUNTRIES AND EMERGING MARKETSDevices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases, and for the patient rehabilitation. However access to these devices is an ongoing challenge particularly in lowand middle income countries (LMICs).The emergency care research institute (ECRI) nomenclature called the universal medical device nomenclature system (UMDNS) the UMDNS terms are harmonized with the classification system of the USMA and exist in ten languages. The global medical device nomenclature (GMDN) codes. The GMDN code is built according to EN ISO 15225 and is a collaborating between the EU, EFTA, USA and Canada. The GMDN terms only exit in English but can be translated with special software. This nomenclature system is required for registering a medical device within the EU. The global harmonization task force described further down has developed a recommended classification system where medical devices are divided into class A, B, C & D where class D represents the highest risk. The world health organization (WHO), with support from the European Union (EU) developed to analyze the barriers in emerging markets to increasing access to safe and high quality medical devices and to examine the contribution that local production and technology transfer of medical devices. The effectiveness of existing regulatory frameworks for medical devices in regulated countries to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the various countries jurisdictions, explores current reforms to improve the existing systems and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safe guard public health and ensure that high-quality and effective technologies reach patients. These regulatory systems differ in their mandate and orientation, organization, pre- and post-market evidence requirements, and transparency of process. Despite these differences, these jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real world use, and exchanging pertinent information on devices with key users such as clinicians and patients. This paper examines the regulatory requirements for medical devices in Argentina, Brazil, Canada, India, Japan, Mexico and Russia, principally focused on strengthening regulatory processes, enhancing post market regulation through more robust surveillance systems and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being consideredalagusundaram77@gmail.comResearch522015LMICS,ECRI,WHO,Premarket requirements,Medical devicesAlagusundaram M,Prathyusha B,Jayachandra Reddy PDepartment of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.,Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.,Department of Pharmaceutics and Drug Regulatory Affairs, Krishna Teja Pharmacy College, Chadalawada Nagar, Tirupati– 517501, Andhra Pradesh, India.