🩺 Class A Medical Devices Registration (Non-Sterile, Non-Measuring)

✅ What are Class A Medical Devices?

Class A medical devices are considered low-risk products as per the Medical Device Rules (MDR), 2017, governed by the Central Drugs Standard Control Organization (CDSCO). Non-sterile and non-measuring Class A devices include items that do not require sterilization and do not provide quantitative measurements.

These devices are generally used for supportive or general healthcare purposes and have minimal impact on patient safety.

📦 Examples of Class A (Non-Sterile, Non-Measuring) Devices:

  • Surgical gloves (non-sterile)

  • Thermometers (non-digital)

  • Walking aids (like crutches)

  • Medical disposable masks (non-sterile)

  • Examination chairs

  • Bandages, cotton rolls

  • Diagnostic test accessories

CDSCO Class A Medical Devices Registration

📝 Regulatory Pathway:

As per CDSCO regulations, manufacturers and importers of Class A (non-sterile, non-measuring) devices must obtain a voluntary registration certificate under the Medical Device Rules, 2017. This process includes:

  1. Identification of device classification

  2. Preparation of documentation as per MDR guidelines

  3. Application filing on CDSCO portal

  4. Review and registration number issuance

This process is relatively straightforward compared to higher-risk device categories (Class B, C, D).

📁 Documents Required:

  • Basic company documents (PAN, GST, etc.)

  • Device master file / product specification sheet

  • ISO 13485 Certificate (if applicable)

  • Product labels and packaging info

  • Free Sale Certificate (for importers)

  • Technical specifications & brochure

  • Drugs licence of importer ( Required only for foreign manufacturer)

  • List of products to be registered

🛡️ Why Compliance is Important:

  • Builds trust and credibility in the market

  • Required for listing on e-commerce platforms (Amazon, Flipkart, etc.)

  • Ensures legal operation in the Indian market

  • Helpful in global trade and exports

🚀 Our Services Include:

  • Classification & Eligibility Check

  • Complete Documentation Support

  • Filing of Application on CDSCO Portal

  • Liaison with Regulatory Authorities

  • Timely Status Tracking & Updates

  • Post-registration advisory & compliance

🔍 Why Choose Zensen Ventures?

We specialize in medical device regulatory consulting with hands-on experience in handling Class A medical devices. Whether you’re a startup, manufacturer, or importer, we ensure seamless, end-to-end assistance with a focus on speed, accuracy, and compliance.

📞 Phone: +91 9600 521 721
🌐 Website: www.zensenventures.in
💬 WhatsApp: +91 9600 521 721

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