Revista de Farmácia e Pesquisa Farmacêutica Acesso livre

Abstrato

The Regulation of Medical Devices Registration in the UAE

Vaibhav Bhosle*

The regulation of medical devices throughout the world is very diverse, ranging from comprehensive to none. In the light of heightening utilization of medical devices increasing, precise and specific regulatory standards are needed to ensure that the devices are safe, well researched and have least undesirable reactions. In the course of recent decades the number, range and complexity of medical devices has improved. These devices regulations have also developed due to an increasing awareness of the need for a more stable approach to regulatory documentation. This will help for both manufacturers selling a product in more than one state and the states introducing regulation. As far as medical devices, the UAE is an import driven market that is developing quickly to keep pace with the nation's extending healthcare infrastructure. The government authority and private healthcare divisions are investing to provide nationwide healthcare solutions to the citizens, emigrants and medical tourists. The necessity for health services in the UAE and other GCC countries are based on a study expected to increase by 240% in the next two decades. Healthcare is regulated both the emirate and federal level. Registration is regulated by the UAE-Ministry of Health (MOH) and it is aimed at sustaining a balance between product quality, safety and effectiveness. The main principle according to the UAE regulation is implementing the registration of all medicines and medical devices with the MOH to be legally circulated within the United Arab Emirates market. This review article summaries the overview of the rules, regulations and requirements in the Ministry of Health of UAE.