Updated on July 06, 2024 06:08:57 PM
CDSCO is the Central Drugs Standard Control Organisation being the most powerful organizations of India. It is the Indian National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and its positioning within the Ministry of Health and Family Welfare.
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.
A medical device is any device that is used for medical purposes. It can be any Article, Instrument, Implant, Reagent etc.
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.
CDSCO, the Central Drugs Standard Control Organisation along with the state regulators is jointly responsible for granting the license by checking various criterias of the devices. CDSCO's main objective is to safeguard public health. Classifying all the Medical Devices on the basis of the extent of risk will make it easier to study them.
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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A medical device is any device intended to be used for medical purposes.
There are two types of Medical Devices
Notified Devices are the Medical Devices that are regulated under the Medical Devices Rules,2017 by the CDSCO. Non-Notified Devices are Medical Devices that have not been mentioned under Notified Devices in the official gazette released by the government of India.
There are 4 classes-A-low risk,B-moderate low risk,C-moderate high risk,D-high risk.
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