Classification of Medical Devices by CDSCO
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Classification of Medical Devices by CDSCO - Types and Categories
CDSCO, the Central Drugs Standard Control Organisation, is one of India’s most powerful organizations. It serves as the Indian National Regulatory Body for cosmetics, pharmaceuticals, and medical devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices, aligning its position with the Ministry of Health and Family Welfare.
What are Medical Devices?
A medical device is any device intended to be used for medical purposes. These can be instruments, apparatus, machines, implants, reagents, software, or other related or similar articles used for prevention, diagnosis, treatment or modification of disease or body function.
Types of Medical Devices
A medical device is any device that is used for medical purposes. It can be any Article, Instrument, Implant, Reagent etc.
- Notified Devices: Notified Devices are the Medical Devices that are regulated under the Medical Devices Rules, 2017 by the CDSCO.
- Non-Notified Devices: Non-Notified Devices are Medical Devices that have not been mentioned under Notified Devices in the official gazette released by the government of India.
Classification of Medical Devices
Medical Devices are Categorized into 4 Classifications based on the extent of risks.
| Category | Amount of Risk | Licensing Authority |
|---|---|---|
| A | Low risk | SLA |
| B | Low moderate risk | SLA |
| C | Moderate high risk | CLA |
| D | High risk | CLA |
There are 37 kinds of Medical Fields involving 200 Medical Devices in each category.
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