CDSCO Launches New Risk Classification Module for Medical Devices

The Central Drugs Standards Control Organization (CDSCO), under the Ministry of Health & Family Welfare, has introduced a significant update to streamline the regulatory approval process for medical devices. A new Risk Classification Module has been launched on the CDSCO Online System for Medical Devices (http://cdscomdonline.gov.in), effective from 27th November 2025. This development is aimed at simplifying the risk classification process for medical devices, excluding In-vitro Diagnostic (IVD) devices.

What Does This Mean for Stakeholders?

The new module provides a user-friendly platform for applicants to submit their risk classification applications for medical devices that are not listed in the CDSCO’s published classification list. This initiative is in line with the Medical Device Rules, 2017, ensuring a more efficient and transparent process for obtaining regulatory approvals.

Key Highlights:

Ease of Application: Applicants can now submit their risk classification requests directly through the CDSCO Online System.
Streamlined Process: The module eliminates complexities, making it easier for stakeholders to comply with regulatory requirements.
Enhanced Accessibility: The system is accessible to all stakeholders, including manufacturers, importers, and distributors of medical devices.

How to Access the New Module?

To access the Risk Classification Module, visit the CDSCO Online System for Medical Devices at http://cdscomdonline.gov.in. The portal is designed to guide users through the application process seamlessly.

Who Should Take Note?

This update is crucial for:

Medical device manufacturers and importers
State/UT Licensing Authorities
COSCO Zonal/Sub-Zonal/Port Offices
IT Cell and CDAC Team

Conclusion

The launch of the Risk Classification Module marks a significant step forward in simplifying the regulatory framework for medical devices in India. By leveraging technology, the CDSCO aims to enhance efficiency, transparency, and compliance in the medical device industry. Stakeholders are encouraged to explore the new module and take advantage of its features to ensure smooth regulatory processes.

Listen to this on our #YouTube Channel

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

We offer Legal advice and litigation support in matters related to Indirect Tax-Customs, FTP, other Indirect Tax matters & Arbitration law, all sorts of Central licensing and related matters. Come and explore the new way of doing business with us!

Source: CDSCO

Disclaimer

Handy Download:

CDSCO CircularDownload

Connect with us for more-

@ Team S J EXIM SERVICES, New Delhi, IN

CP: Ms. Shubhra Jha, Founder

Tel: +91-11-4999 2707 I +91-9999005693

Web: www.sjexim.services

EMAIL: operations@sjexim.services I shubhra@sjexim.services

Facebook: www.facebook.com/sjeximservices

LinkedIn: https://www.linkedin.com/company/90794255/admin/feed/posts/

YouTube: https://www.youtube.com/@sjeximIndia

Subscribe our WhatsApp Channel: https://whatsapp.com/channel/0029VaTxDT8JZg4CHEOSoK47

Subscribe our Telegram Channel: https://t.me/sjeximindia

S J EXIM Services