Updated on July 06, 2024 11:52:00 PM
CDSCO, the Central Drugs Standard Control Organisation is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices. Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Device and its positioning with the Ministry of Health and Family Welfare.
The Indian Government has announced its plan to bring all Medical Devices, including Implants and Contraceptives under a review of the Central Drugs Standard Control Organisation.
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.
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.
There are two types of Medical Devices
There are two types of Medical Devices
CDSCO is Constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of Medical Product manufactured, imported and distributed in the country. Its vision and mission is to protect & promote public health in India and to safeguard and enhance the public health by quality and safety of Medical Devices.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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CDSCO stands for Central Drugs Standard Control Organisation
The Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and its positioning with the Ministry of Health and Family Welfare.
Notified are the devices which have been regulated under Medical Device Rules,2017 by the CDSCO.
Notified and Non-Notified devices are the two types of Medical Devices with 4 classes involved in it A-B-C-D based on its risk level.
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