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.
Examples 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.
