Classification of Medical Devices by CDSCO - Types and Categories

Updated on December 09, 2023 05:30:18 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.

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.

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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.
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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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Conclusion

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.

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Frequently Asked Questions

What can be considered as a Medical Device?

A medical device is any device intended to be used for medical purposes.

How many types of Medical Devices are there?

There are two types of Medical Devices

What are Notified and Non-Notified 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.

What is the hierarchy of the classification of Medical Devices based on their risk level?

There are 4 classes-A-low risk,B-moderate low risk,C-moderate high risk,D-high risk.

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