CDSCO Registration for SaMD: Ensuring Smooth Compliance with Regulations

In the digital healthcare era, Software as a Medical Device (SaMD) plays a critical role in diagnostics, treatment planning, and patient management. Obtaining CDSCO Registration for SaMD is essential to ensure that medical software meets strict safety and performance standards, minimizing errors that could have serious consequences for patients and healthcare providers.

Under India’s Medical Device Rules, 2017, software performing medical functions independently—without being part of a hardware device—is classified as SaMD. If you’re a medical software developer, manufacturer, or importer, obtaining CDSCO Medical Device Registration is a mandatory step toward regulatory compliance.

At Operon Strategist, we guide you through the complete CDSCO SaMD registration process, ensuring your software meets all regulatory standards for India.

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What is Software as a Medical Device (SaMD)?

SaMD refers to software that performs medical functions independently of any hardware device. Examples include in-vitro diagnostic (IVD) software, AI-powered image analysis, and mobile or desktop healthcare applications.

Key points:

  • SaMD operates on general-purpose platforms like smartphones, tablets, or computers.
  • Software embedded in a hardware medical device is not classified as SaMD.
  • SaMD may work independently or in combination with other software for medical or general purposes.
CDSCO Registration for SaMD

Regulatory Authorities for SaMD in India

The licensing of SaMD in India falls under the jurisdiction of the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLA), depending on the classification: 

Class A & Class B SaMD → Licensed by the State Licensing Authority (SLA) 
 Class C & Class D SaMD → Licensed by CDSCO 

Why is CDSCO SaMD Registration Important?

Obtaining CDSCO approval for Software as a Medical Device (SaMD) is not just a regulatory requirement—it is a critical step in ensuring safety, trust, and credibility throughout the healthcare ecosystem. 

For Healthcare Providers 

✔ Confirms the software meets stringent safety and performance standards. 
✔ Reduces legal liabilities associated with software-related failures. 
✔ Builds confidence in adopting reliable and compliant medical software. 

For Patients 

✔ Ensures adherence to high-quality standards for medical software. 
✔ Minimizes risks associated with diagnostic or treatment inaccuracies. 
✔ Enhances patient safety and improves overall clinical outcomes. 

For the Industry 

✔ Encourages transparency and accountability in SaMD development. 
✔ Simplifies market entry by demonstrating regulatory compliance. 
✔ Strengthens brand credibility and competitiveness in the healthcare sector.

Classification of Software as a Medical Device (SaMD)

CDSCO categorizes SaMD into four classes based on risk level and intended use:  

Class A SaMD – Low Risk 

  • Continuous Glucose Monitor Retrospective Data Analysis Software 
  • Ataxiagraph with Interpretive Software 

Class B SaMD – Moderate Risk 

  • Continuous Glucose Monitor Secondary Display Software 
  • Insulin Pump Secondary Display Software 
  • Electrocardiograph Software for Home Use 
  • Automated Radiological Image Processing Software 
  • AI-Guided Image Acquisition & Optimization Software 

Class C SaMD – High Risk 

  • Insulin Pump Therapy Adjustment Calculator (for healthcare professionals) 
  • Orthodontic Treatment Planning Software 
  • Dental Abutment Design Software 
  • Brain Injury Interpretive Software 
  • Computerized Cognitive Assessment Aid for Concussion 
  • Ventilator Control Software 
  • Radiation Treatment Planning Software 

How to Register SaMD with CDSCO in India?

Licensing Requirements 

SaMD Class 

License Requirement 

Issuing Authority 

Class A & B 

MD 5 License 

State Licensing Authority (SLA) 

Class C & D 

MD 9 License 

CDSCO 

Imported SaMD 

MD 15 Import License 

CDSCO 

 

Validity of CDSCO SaMD License

Once granted, a CDSCO SaMD license remains valid indefinitely, provided the renewal fee is paid every five years. 

Step-by-Step CDSCO SaMD Registration Process

1️⃣ Register your organization on the CDSCO SUGAM Portal. 
 2️⃣ Fill & submit the required online application. 
 3️⃣ Upload documents and pay the necessary fees. 
 4️⃣ CDSCO reviews your application for compliance verification. 
 5️⃣ Receive the CDSCO license upon approval. 

Need more clarity on the CDSCO registration process for SaMD?

Contact us now!

Role of Operon Strategist in CDSCO Registration for SaMD

At Operon Strategist, we simplify the CDSCO Registration for SaMD process by providing end-to-end consulting and regulatory support. Our team of experts ensures that your Software as a Medical Device (SaMD) complies with all Indian regulations and international standards, helping you achieve smooth, timely, and fully compliant market approval.

How Operon Strategist Supports You:

  • Regulatory Guidance: Expert advice on SaMD classification, CDSCO requirements, and licensing pathways.
  • Documentation & Technical File Preparation: Assistance in preparing Device Master Files (DMF), risk assessments, clinical evaluation reports, and labeling review.
  • QMS & ISO Compliance: Support in establishing or validating quality management systems compliant with ISO 13485 and other relevant standards.
  • Import & Market Readiness: Guidance for domestic and imported SaMD, including import license applications and post-market surveillance requirements.
  • End-to-End Project Management: From registration to compliance, we streamline the process to reduce delays and regulatory risks.

With over a decade of experience, Operon Strategist is a trusted partner for software developers, manufacturers, and importers seeking fast, reliable, and fully compliant CDSCO Registration for SaMD in India.

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