Manufacturing Registration for Class A Medical Devices as per GSR 777(E)

Streamlined Compliance for Low-Risk Devices

The Central Drugs Standard Control Organisation (CDSCO) mandates registration for all medical devices in India, including low-risk Class A (non-sterile and non-measuring) devices. While their registration process is simplified, understanding and meeting CDSCO requirements are crucial for market entry.

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

These are medical devices characterized by:

·         Low Risk: Minimal potential for harm.

·         Non-Sterile: Not intended for use in sterile environments or direct contact with sterile body parts.

·         Non-Measuring: Do not quantify physiological parameters (e.g., blood pressure, temperature).

Examples include: Tongue depressors, bandages, non-electric thermometers, surgical drapes (non-sterile), and examination gloves (non-sterile).

Who Needs to Register?

• Both Indian Manufacturers and Importers of Class A (non-sterile, non-measuring) medical devices are required to register their products with the CDSCO. Importers will additionally need a Free Sale Certificate (FSC) from the country of origin.

Key Requirements:

The registration process, conducted via the CDSCO MD Online Portal, requires submission of:

• Company Information: Manufacturer/Importer details.
• Device Details: Comprehensive information on the device’s intended use, classification, materials, etc.
• Quality Management System (QMS): A valid ISO 13485 certificate (accredited by NABCB or IAF).
• Undertakings: Declarations of compliance with safety, performance, and Medical Device Rules, 2017.
• For Importers: Self-attested foreign manufacturing site registration and a Free Sale Certificate.

Fast & Easy Registration:

Upon successful submission of all required information on the CDSCO MD Online portal, manufacturers and importers can receive their Class A medical device registration number almost immediately within the online system.

How MDR Consultants Can Help:

Despite the simplified process, navigating regulatory nuances and ensuring accurate documentation can be challenging. MDR Consultants offer expert assistance to:

• Verify Device Classification: Confirm your device correctly falls under Class A (non-sterile, non-measuring).
• Prepare Documentation: Ensure all required documents are complete, accurate, and compliant.
• Assist with Online Submission: Guide you through the CDSCO MD Online registration portal.

Facilitate Communication: Liaison with CDSCO if necessary.

Benefits of Partnering with MDR Consultants:

• Reduce Errors: Minimize the risk of application rejections.
• Expedite Registration: Achieve faster time-to-market for your devices.
• Gain Peace of Mind: Trust your registration to regulatory experts.