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CDSCO Classification of Medical Devices - Types and Categories
CDSCO stands for the Central Drugs Standard Control Organisation, India's national regulatory authority for cosmetics, pharmaceuticals, and medical devices.
The Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices within the Central Drugs Standard Control Organisation (CDSCO), which operates under the Ministry of Health and Family Welfare.
What Are Medical Devices?
Medical devices encompass a wide range of products intended for medical use. These include instruments, apparatus, machines, implants, reagents, software, and similar items used for the prevention, diagnosis, treatment, or alteration of diseases and bodily functions.
Types of Medical Devices
Medical devices can be categorized as follows:
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Notified Devices: These are medical devices regulated under the Medical Devices Rules, 2017 by the CDSCO (Central Drugs Standard Control Organisation).
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Non-Notified Devices: These are devices not listed in the official gazette by the Government of India and are not subject to the same regulatory oversight as notified devices.
Classification of Medical Devices
Medical devices are classified into four categories based on their risk levels, as regulated by the CDSCO. The Drug Controller General of India (DCGI) oversees the regulation of these devices within the Ministry of Health and Family Welfare.
| Category | Amount of Risk | Licensing Authority |
|---|---|---|
| A | Low risk | SLA |
| B | Low moderate risk | SLA |
| C | Moderate high risk | CLA |
| D | High risk | CLA |
Conclusion
The Central Drugs Standard Control Organisation (CDSCO), in collaboration with state regulators, is responsible for licensing medical devices by evaluating various criteria. The main objective of the Central Drugs Standard Control Organisation (CDSCO) is to safeguard public health. Proper classification of medical devices based on risk helps facilitate more effective regulation and oversight.
For any questions regarding the most recent update on CDSCO registration licenses, please reach out to us via email at cs@absoluteveritas.com
Frequently asked questions (FAQ)
What Can Be Considered a Medical Device?
A medical device is any product designed for medical purposes, including instruments, apparatus, machines, implants, reagents, and software used to prevent, diagnose, treat, or modify diseases and bodily functions.
How Many Types of Medical Devices Are There?
Medical devices are classified into two main types.
What Are Notified and Non-Notified Medical Devices?
Notified Devices: Medical devices that are regulated by the CDSCO under the Medical Devices Rules, 2017. These devices must meet specific regulatory standards and guidelines.
Non-Notified Devices: Medical devices not mentioned in the official government gazette, and hence not subject to the same regulatory controls as notified devices.
What Is the Hierarchy of Medical Device Classification Based on Risk Level?
There are four risk categories
-Class A: Low risk
-Class B: Moderate Low Risk
Class C: Moderate High Risk
Class D: High Risk
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