India’s medical device industry is expanding rapidly, thanks to increased healthcare demand, digital innovation, and government initiatives like Make in India. But alongside opportunity comes responsibility—especially regulatory responsibility. One of the most crucial requirements for manufacturers and importers of medical devices in India is CDSCO registration.

Whether you're a startup entering the market or an established brand scaling operations, understanding the CDSCO process is essential for legal market access and long-term success. Here’s your complete guide to navigating CDSCO registration in 2025.

What is CDSCO?

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body for pharmaceuticals and medical devices. Under the Drugs and Cosmetics Act, 1940, CDSCO is responsible for regulating the import, manufacture, and sale of medical devices in India. Registration with CDSCO is mandatory for all Notified Medical Devices, which now includes a broad range of products due to expanded regulations in recent years.

Which Devices Require CDSCO Registration?

As of 2025, all Class A, B, C, and D medical devices require registration. These classes are based on the level of risk:

• Class A: Low risk (e.g., thermometers)

• Class B: Low to moderate risk (e.g., suction equipment)

• Class C: Moderate to high risk (e.g., dialysis machines)

• Class D: High risk (e.g., implantable devices like pacemakers)

Even software intended for medical purposes may fall under CDSCO regulation.

CDSCO Registration Process

Here’s a step-by-step overview of how to obtain CDSCO registration:

1. Determine the Classification
   Accurately identify your device class. Misclassification can lead to rejection or delays.

2. Appoint an Authorized Indian Agent (For foreign manufacturers)
   If you’re importing, you must have an authorized Indian representative to interact with CDSCO.

3. Prepare Technical Documentation
   This includes Device Master File (DMF), Plant Master File (PMF), clinical evaluation reports, labeling details, and quality certifications (e.g., ISO 13485).

4. Submit the Application via Sugam Portal
   Applications are filed online through the CDSCO Sugam Portal. Each class of device has specific requirements and approval timelines.

5. Pay the Prescribed Fee
   Registration fees vary by device class and whether it's a domestic or import license.

6. Await Review and Approval
   CDSCO may request additional clarification or documents. Once satisfied, it issues the registration certificate.

How Long Does CDSCO Registration Take?

The timeline can range from 4 to 9 months, depending on the class of device, completeness of documentation, and whether additional reviews or audits are required.

Agile Regulatory: Your Partner in CDSCO Compliance

Agile Regulatory simplifies the complex CDSCO registration process for manufacturers, importers, and distributors. With years of hands-on experience and a deep understanding of Indian regulatory frameworks, Agile Regulatory assists with product classification, document preparation, application filing, and follow-ups. Whether you’re launching a new device or expanding into India’s MedTech market, Agile Regulatory ensures you stay compliant while focusing on innovation and growth.

Conclusion

With India becoming a global hub for medical device manufacturing and innovation, CDSCO registration is no longer optional—it’s a strategic business step. By proactively aligning with regulatory norms, you not only ensure lawful market entry but also enhance brand credibility and investor trust. In 2025 and beyond, success in MedTech begins with compliance.