The Central Drugs Standard Control Organisation (CDSCO) has released a new circular announcing the launch of the Risk Classification Module on the Online Medical Device System (OMDS).
This update is an important step toward making India’s medical device regulatory framework more transparent, predictable, and aligned with MDR 2017.
What Is the Risk Classification Module?
The module provides a centralized, searchable database where manufacturers can view the official risk class of medical devices (Class A, B, C, D) as per the Medical Device Rules, 2017.
It includes:
- Device category & intended use
- Applicable risk class
- Relevant MDR rules
- Updated classifications for new and existing products
This helps eliminate confusion and ensures that manufacturers select the correct class during licensing.
Why This Update Matters
1. Reduces Application Errors
Misclassification is one of the biggest reasons for approval delays. This module gives clarity before filing MD-5, MD-9, MD-14, and import applications.
2. Faster Licensing & Fewer Queries
The CDSCO can now verify your chosen risk class quickly, reducing back-and-forth communication.
3. Aligns India With Global Best Practices
Similar to EU MDR classification principles, India now offers an online, transparent system.
4. Helpful for Start-ups & New Manufacturers
Easy access to classification helps new players choose the right regulatory pathway.
How Manufacturers Can Use the Module
- Log in to the Online Medical Device System (OMDS)
- Open the Risk Classification Module
- Search for your device category
- Review official class, rule number, and description
- Use this classification in your upcoming license or registration filings
This tool ensures that your submission is aligned with CDSCO expectations from the start.
What Manufacturers Should Do Next
- Recheck the classification of all current and upcoming devices
- Update Technical Files and regulatory strategies accordingly
- Train RA teams on using the module
- Monitor the portal for updates or classification revisions
This proactive approach helps avoid delays and ensures compliance with MDR 2017.
Conclusion
The launch of CDSCO’s Risk Classification Module is a welcome improvement for India’s MedTech industry.
It provides clarity, consistency, and speed, making regulatory submissions smoother and reducing uncertainty for manufacturers.
If you manufacture or import medical devices in India, this new module should now be part of your standard regulatory workflow.
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