Why CDSCO Registration for SaMD Matters
CDSCO Registration for Software as Medical Device (SaMD) is a mandatory step for manufacturers and importers who want to legally market medical software in India. Whether it’s a mobile app monitoring diabetes, AI-driven diagnostic tools, or image-analysis software, SaMD must meet strict regulatory requirements.
In India, the Central Drugs Standard Control Organization (CDSCO) regulates SaMD under the Medical Devices Rules (MDR), 2017. Securing CDSCO Registration for Software as Medical Device not only ensures patient safety and effectiveness but also boosts global market acceptance.
With the latest deadline for Class C and Class D SaMD (effective October 1, 2023), timely compliance with CDSCO’s licensing regime is critical to avoid costly delays and penalties.
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What is Software as a Medical Device (SaMD)?
SaMD refers to software that performs medical functions independently, without being part of a physical device. Common examples include:
- Mobile apps tracking blood glucose levels
- AI software analyzing medical images (X-ray, MRI, CT scans)
- ECG irregularity detection tools
- Digital therapy platforms for mental health (CBT apps)
Compliance with CDSCO Registration for Software as Medical Device ensures that these applications meet Indian safety and quality standards.
Key Standard for SaMD Development – IEC 62304
IEC 62304 is the global benchmark for medical software development, covering:
- Risk management
- Verification & validation
- Configuration control
- Ongoing maintenance
Latest CDSCO Update on Class C & D SaMD Registration
According to GSR 102(E), 11.02.2020, Class C and Class D SaMD now require Licensing instead of simple registration.
Effective Date: October 1, 2023
- Licensing applies to manufacturers and importers
- Applications must be submitted via CDSCO online portal
- Compliance with MDR 2017 is mandatory
Read our blog Global Regulations for Software as Medical Device for more details.
List of Class C Software as Medical Device
Take a look at a couple of Class C Software as Medical Device below –
Sr. No. | Device Name | Risk Class |
1. | Coronary Vascular Physiologic Simulation Software | C |
2. | Angiographic Coronary Vascular Physiologic Simulation Software | C |
3. | Diabetic Retinopathy Detection Device | C |
4. | Software For Visualization of Vascular Anatomy and Intravascular Devices | C |
5. | Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer | C |
Take a moment to review the full spectrum of Class C Software as Medical Device outlined here.
Documents Required for CDSCO Licensing
Manufacturing License (Class C & D SaMD)
Manufacturers must provide:
- Site master file & facility layout details
- Quality management system (ISO 13485)
- Device master file
- Process validation records
- Post-market surveillance plan
Read More: CDSCO manufacturing license
Import License (Class C & D SaMD)
Importers must provide:
- Free Sale Certificate (USA, EU, Japan, Australia, Canada)
- ISO 13485 certification
- Device master file
- Clinical evidence (if applicable)
- CDSCO application & prescribed fees
Read More: CDSCO import license
Start your CDSCO Registration for SaMD with Operon Strategist today!
How Operon Strategist Helps with CDSCO Registration for SaMD
With 12+ years of regulatory experience, Operon Strategist provides end-to-end support for:
- SaMD classification under CDSCO guidelines
- Preparation & submission of complete licensing documents
- Gap analysis for MDR 2017 compliance
- IEC 62304 integration guidance
- Liaison with CDSCO during approval
- Post-approval support and surveillance
Start your CDSCO Registration for Software as Medical Device today with Operon Strategist and ensure fast, compliant market entry.
