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Class A (Non-Sterile & Non-Measuring) Medical Device Registration in India

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.

Ready to Register Your Class A Medical Device?

Contact MDR Consultants today for a free consultation and quotation. Let us help you efficiently register your Class A medical device and bring it to the Indian market swiftly.

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