UNITED STATE (US)
The United State Food and Drug Administration is the regulatory body of the US responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
EUROPEAN UNION
European Commission regulates the medical device in Europe. This Commission works closely with the European Medicine Agency (EMA), which is responsible for the scientific evaluation, supervision, monitoring of the safety of medical devices.
INDIA
Control Drug Standard Central Organisation (CDSCO) is Indiaโs regulatory body regulating medical devices in the Indian market. Whether one wants to manufacture or import, both need a license to sell and distribute their medical devices.