Class A Manufacturing
Registration (GSR 777(E))
Experience a streamlined compliance and rapid registration process for low-risk, non-sterile, and non-measuring medical devices in India.
Consult Our CDSCO Experts
Streamlined Compliance for Low-Risk Devices
While the CDSCO mandates registration for all medical devices in India, it has implemented a significantly simplified pathway under GSR 777(E) for specific low-risk products.
Qualifying Device Characteristics:
Low Risk
Minimal potential for harm.
Non-Sterile
No contact with sterile environments.
Non-Measuring
Does not quantify physiological parameters.
Examples:
Tongue depressors, bandages, non-electric thermometers, non-sterile surgical drapes, and examination gloves.
Key Requirements for Registration
Indian manufacturers (and importers) must utilize the CDSCO MD Online Portal. Upon successful submission of accurate information, a registration number is generated almost immediately within the system.
Quality Management System (QMS)
A valid ISO 13485 certificate, accredited by NABCB or IAF, is a mandatory prerequisite.
Device & Company Details
Comprehensive information regarding the manufacturer/importer, device intended use, classification, and materials of construction.
Undertakings
Formal declarations confirming strict compliance with safety, performance standards, and the Medical Device Rules, 2017.
Minimize Risk of Rejection
Despite the simplified "instant" registration process, any inaccurate documentation or misclassification can lead to immediate rejection or compliance issues later.
- Verify correct Class A classification
- Ensure ISO 13485 certificate validity (NABCB/IAF)
- Flawless CDSCO MD Online submission