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Dated: 11.04.2025

CDSCO Introduces Auto-Generated Neutral Code System for Medical Device Exports

The Central Drugs Standard Control Organization (CDSCO) has announced the implementation of a system-generated Neutral Code mechanism for exporters of medical devices under the Medical Devices Rules, 2017.

What is a Neutral Code?

A Neutral Code is a unique identifier used by manufacturers when exporting medical devices, allowing shipment of products without linking to specific batch details or branding, while still remaining within the regulatory compliance framework. This is particularly useful in contract manufacturing and white-label exports.

Key Highlights of the New Mechanism

• Effective Platform: The new provision is now live on the Online System of Medical Devices portal – https://cdscomdonline.gov.in.
• Automated Generation: Manufacturers with valid manufacturing licenses can now directly generate and download the Neutral Code from their own CDSCO dashboard without separate approval from the Central Licensing Authority.
• Discontinuation of Manual Issuance: The previous method of applying for Neutral Code issuance manually through the Central Licensing Authority has been rendered non-functional.
• Scope: This provision applies to exports only and is governed under the Medical Devices Rules, 2017.

Benefits of the Auto-Generated Neutral Code

• Simplified Process: Removes administrative bottlenecks and enables real-time code generation.
• Enhanced Transparency: Ensures traceability and regulatory compliance without dependency on manual intervention.
• Faster Approvals: Supports manufacturers with tight export deadlines by providing instant access to export codes.
• Boost to Exports: Aims to facilitate India’s vision of becoming a global hub for medical device manufacturing and exports.

Who Should Take Note?

• Licensed Medical Device Manufacturers.
• Regulatory Compliance Teams in Export-Oriented Units.
• State and UT Licensing Authorities.
• Third-Party and Contract Manufacturers.

All stakeholders are required to transition to the new system for any Neutral Code issuance related to exports moving forward.

Official Notification Details

• Issuing Body: Central Drugs Standard Control Organization, Medical Devices Division
• Dated: 09 April 2025

Conclusion

The CDSCO’s move toward digitalization through the auto-generated Neutral Code mechanism is a welcome step for India’s medical devices sector. It not only reduces regulatory friction but also enhances the credibility of Indian medical device exports in international markets. Stakeholders are advised to familiarize themselves with the updated process and ensure compliance with the new system.

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

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