Applications of Nanomaterials in Medical Procedures and Treatments

Regulators of Biomedical Devices

Author(s): Umut Beylik and Erhan Akdoğan *

Pp: 272-293 (22)

DOI: 10.2174/9789815136951123040010

* (Excluding Mailing and Handling)


Regulators of medical devices in the world regulate global competition in the medical device sector, and on the other hand, they play a decisive role in security, performance, and access issues. Technological development has also increased in the medical device industry, and medical devices have become more important in the diagnosis and treatment of health services. However, it is important that legal regulations must be implemented correctly and effectively in order to prevent public health or unethical behaviors. In this context, the regulations of the United States of America (USA) and the European Union (EU), the leaders in the sector, along with their high markets are discussed. In addition, medical device regulations in Japan, China, and Brazil, which have an important position in technological development and competition and have high potential, are also included. Considering the urgency and possible consequences of healthcare services, it is necessary to consider the fund and the regulations of the medical device sector separately in individual, national and global dimensions, from macro to micro. In addition to the safety, cost, and effectiveness of medical devices, it is important to discuss the conformity assessment, approval system processes, and how long it takes for a medical device to be put on the market. Considering the rapid technology change, regulations should be made to carry out the licensing and approval processes effectively and quickly in medical device regulations. 

Keywords: Biomedical devices, Classification, Comparison, Medical devices, Regulations, Regulatory, Safety.

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