Notification/Circular No. – MED/52/2024-eoffice-Part (1)
Document Date – April 9, 2025
Applicable Act/Rule – Medical Devices Rules, 2017
Background and Rationale
To simplify regulatory procedures and enhance the ease of doing business in the medical device sector, the Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has announced a major shift in the process for issuing Neutral Codes for export purposes under the Medical Devices Rules, 2017. Neutral Codes are used by manufacturers when exporting medical devices where branding is neutral or anonymous.
Amendments and Their Implementation
Advantages of the Amendment
Implications and Future Prospects
This update significantly improves regulatory responsiveness in the medical devices sector, especially for exports. By reducing human intervention and adopting automated processing, CDSCO is aligning with the broader government strategy of Digital India and Ease of Doing Business. It is expected that similar automation may be extended to other approval processes in the medical device regulatory framework.
Conclusion
The CDSCO’s move to operationalise auto-generated Neutral Codes via its online portal marks a progressive step in digital regulation. It reduces compliance delays for manufacturers, supports global competitiveness, and exemplifies transparent governance in India’s medical device sector.
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