Class A Import Registration
as per GSR 777(E)
Navigate the simplified CDSCO registration process for low-risk, non-sterile, and non-measuring medical devices entering the Indian market.
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What Are Class A Devices?
The Central Drugs Standard Control Organisation (CDSCO) classifies medical devices based on risk. Class A devices represent the lowest risk category and are subject to a significantly streamlined registration process. To qualify for this simplified pathway, a device must be:
Low Risk
Minimal potential for injury or adverse effects.
Non-Sterile
Does not contact sterile body tissues or require sterilization.
Non-Measuring
Does not take quantitative physiological measurements.
Examples of Eligible Devices:
- Tongue depressors
- Non-sterile bandages
- Non-electric thermometers
- Non-sterile surgical drapes
- Examination gloves
- Bedpans
- Crutches
- Stethoscopes
- Cotton balls
Registration Requirements
Since October 2022, registration through the CDSCO's official MD Online portal has been legally mandatory for all Class A (non-sterile, non-measuring) devices. However, a major advantage for these low-risk products is the Self-Registration provision, which greatly accelerates market entry.
Who is Eligible to Register?
Domestic Manufacturers
Any Indian company that manufactures these specific Class A devices locally.
Importers
Indian entities importing these devices from overseas. Importers are required to secure a Free Sale Certificate (FSC) from the country of origin.
Need Assistance?
Even with self-registration, navigating the CDSCO portal and ensuring all documentation is accurate can be challenging. Our regulatory experts are here to streamline your market entry.
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