Regulation of all Medical Devices under CDSCO Directive
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Regulation of all Medical Devices under CDSCO Directive
The Central Drugs Standard Control Organisation is one of the powerful organizations in India. CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health and Family Welfare.
What are Medical Devices under CDSCO?
A Medical Device is any article, instrument, apparatus, machine, implant or reagent that is manufactured, sold, represented for use in the diagnosis, treatment, mitigation, prevention or care of human or animal disease, disorder, condition or pregnancy.
Medical Devices are divided into 4 categories according to their risk levels under CDSCO which needs licensing from the concerned authority to conduct various activities like sale, distribution, import and manufacture in the country.
Classification and Types of Medical Devices under CDSCO
Medical Devices are Categorized into 4 Classifications under CDSCO based on their extent of risks.
| Category | Amount of Risk |
|---|---|
| A | Low risk |
| B | Low to moderate risk |
| C | Moderate to high risk |
| D | High risk |
There are 37 kinds of Medical Fields consisting of nearly 200 Medical Devices in each category.
Types of Medical Devices
There are two types of Medical Devices
- 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.
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