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.
