Government agencies responsible for regulating Medical Devices in India.
1. The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
2. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
3. In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).

In India Device classification Consistent with GHTF guidance and the EU medical device directives, Medical devices are to be classified as Class A (devices involving lowest risk levels such as thermometers, tongue depressors), Class B (low to moderate risks such as hypodermic needles, suction equipment),Class C (moderate to high risks such as lung ventilator, bone fixation) and Class D (highest risks such as heart valves, implantable devices). And India follows international standard ISO 13485: 2003 quality management systems for medical devices, published by the Bureau of Indian Standards (BIS) as Indian national standard IS 15579: 2005.

In India not all medical devices need registration Currently their is only 40-50 medical devices which require registration. For all other medical devices that do not require registration, the manufacturer should obtain a No Objection Certificate (NOC) from the DCGI. The NOC is a letter from the DCGI stating that the product does not require registration and can be imported freely into India.