ABSTRACT
According to the Biomedical Devices rule that came into effect on January 1, 2018, medical devices are classified into one of four classes: A, B, C, or D, depending on the usage and the risk that is linked with the device. Therefore, the process of registering biomedical equipment is determined by the class of the device. The State Licensing Approval Authority (SLA) is the body that has the authority to grant permission for biomedical devices. Class A devices are thought to represent a minimal risk to patients, but class B devices have a minimal risk that could potentially increase. Both Class A and Class B devices are examples of relatively typical types of biomedical equipment for which the market standard is readily available. Class C and Class D biomedical devices involve an associated risk if they are not implanted in the right manner, and the Central Licensing Approval Authority (CLA) is the authority responsible for the issuance of licences. In this category of biomedical devices, the generation of safety data and the completion of clinical trials are prerequisites in accordance with the regulations that the nation has established. Biomedical equipment that originated in nations that are part of the Global Harmonization Task Force (GHTF), such as the United States of America, Canada, Australia, and Japan, are not required to undergo a separate clinical trial in India. The notarised Quality Certificates—ISO 13485—and the Conformities Europenne (CE) certificate are both applicable for biomedical equipment that originated from any of the European countries. In this chapter, we discussed the detailed steps to be taken, as well as the data requirements, to obtain approval for the biomedical device.
