The regulatory authorities recognize different classes of medical devices based on their design complexity, their use characteristics, and their potential for harm if misused. Medical devices are categorized as per every specific country or region. The regulatory authorities also recognize that some devices are also categorized which provide the medical device in combination with drugs, and regulation of these combination products takes this factor into consideration.

There is the national regulatory body, CDSCO for Indian medical devices and pharmaceuticals, it is the licensing authority. The role of CDSCO is to provide the approval to any new medical device which is in the process to be imported to India. Within CDSCO, Drug Controller General of India (DCGI) is the final authority and controls medical devices and pharmaceuticals. The Drug Controller General of India is in charge of endorsement of licenses of particular categories of Drugs and Medical Devices such as IV-Fluids, blood and blood products, Vaccines and all medical devices. The Medical equipment manufacturing process in India is classified and categorized under the CDSCO guideline.

“Those medical devices fall under Class A are considered low-risk devices, such as thermometers and tongue depressors. Low- to moderate-risk medical devices such as hypodermic needles fall under Class B.Lung ventilators and bone fixation plates medical devices fall under Class C and considered moderate-to high-risk devices class D, high-risk devices are Heart valves and implantable defibrillators.”