Class A Import Registration as per GSR 777(E)

The Central Drugs Standard Control Organisation (CDSCO) is the principal regulatory body for medical devices in India. For Class A (non-sterile and non-measuring) medical devices, considered low-risk, the CDSCO has implemented a notably simplified registration process. However, even with this streamlined approach, understanding the specific CDSCO requirements and ensuring accurate documentation remains crucial for seamless market entry.

What are Class A (Non-Sterile and Non-Measuring) Medical Devices?

 These devices are categorized based on their low-risk profile and specific characteristics:

·         Low Risk: They present a minimal potential for injury or adverse effects on users or patients.

·         Non-Sterile: They are not intended for direct contact with sterile body tissues or fluids, meaning they do not require sterilization before use.

·         Non-Measuring: They do not take quantitative measurements on the user’s body. While they may provide qualitative information, they do not quantify physiological parameters.

oExamples of Class A (Non-Sterile and Non-Measuring) Medical Devices include:

• Tongue depressors
• Bandages (non-sterile)
• Non-electric thermometers
• Surgical drapes (non-sterile)
• Examination gloves (non-sterile)
• Bedpans
• Crutches
• Stethoscopes (non-electronic)
• Cotton balls

Who Can Register Class A Devices with the CDSCO?

Both domestic manufacturers and importers are eligible to register Class A (non-sterile and non-measuring) medical devices:

• Manufacturers: Any Indian company that manufactures Class A (non-sterile and non-measuring) devices.
• Importers: Indian companies that import Class A (non-sterile and non-measuring) devices from overseas manufacturers. Importers must additionally secure a Free Sale Certificate (FSC) from the country of origin.

Regulatory Requirements: Registration is Mandatory

• Registration Required: Since October 2022, all Class A (non-sterile and non-measuring) devices are legally required to be registered through the CDSCO’s official online portal (MD Online).
• Self-Registration: A significant benefit for these low-risk devices is the provision for manufacturers and importers to self-register their devices, which streamlines the process significantly.