CDSCO Registration for Software as a Medical Device: Ensuring Smooth Compliance with Regulations

In today’s digital healthcare landscape, software plays a crucial role in diagnostics, treatment, and patient management. However, ensuring the safety and reliability of medical software is paramount, as any malfunction can have serious consequences. 

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

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CDSCO Registration for SaMD

What is Software as a Medical Device (SaMD)?

SaMD refers to software that carries out medical functions on its own, without being embedded in a hardware device. It includes in-vitro diagnostic (IVD) software and can operate on general-purpose platforms like smartphones, tablets, and computers. 

However, if software is an integral part of a hardware medical device, it does not fall under SaMD. SaMD solutions can work independently or in combination with other medical or general-purpose software. 

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?

A CDSCO license isn’t just about compliance—it provides assurance, trust, and credibility across the healthcare ecosystem. 

For Healthcare Providers 

✔ Ensures software meets strict safety and efficacy standards. 
✔ Reduces legal risks from software malfunctions. 
✔ Builds confidence in medical software solutions. 

For Patients 

✔ Guarantees adherence to high-quality standards. 
✔ Minimizes risks related to diagnostic and treatment errors. 
✔ Enhances patient safety and overall healthcare outcomes. 

For the Industry 

✔ Promotes transparency and accountability in software development. 
✔ Facilitates market entry by ensuring regulatory compliance. 
✔ Strengthens credibility and competitiveness in the healthcare market. 

Classification of Software as a Medical Device (SaMD)

CDSCO classifies SaMD into four categories based on risk levels: 

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 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?

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Need Help with CDSCO SaMD Registration?

Navigating the SaMD registration process can be complex, but you don’t have to do it alone! Operon Strategist specializes in regulatory consulting for SaMD, ensuring a smooth and hassle-free registration process. 

📞 Get Expert Assistance Today! 
Contact Operon Strategist to streamline your SaMD registration and compliance process! 

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