New Provision for Subsequent Importers in CDSCO Portal

The Directorate General of Health Services, under the Central Drugs Standard Control Organization (CDSCO), has taken a significant step to streamline the regulatory approval process for medical devices and in-vitro diagnostics (IVDs). In a circular dated September 15, 2025, CDSCO announced the launch of a separate provision for “Subsequent Importers” in its online portal (https://cdscomdonline.gov.in). This initiative aims to enhance transparency, accountability, and efficiency in the regulatory system.

Key Highlights of the Update:

Simplified Regulatory Procedures:
- CDSCO has introduced various measures to simplify the approval process, including publishing “Tool Tips” on its website to clarify technical requirements for applications.
- The procedure for “Brand Approval” has been streamlined, separating it from routine endorsement applications to reduce processing timelines and expedite approvals.
New Provision for Subsequent Importers:
- Effective September 11, 2025, the CDSCO online portal now includes a dedicated provision for “Subsequent Importers.”
- This feature allows applicants to import medical devices and IVDs that have already been approved by the Central Licensing Authority under the Medical Devices Rules, 2017.
Application Process:
- Applicants intending to import already-approved medical devices and IVDs can now submit their applications as subsequent importers.
- A detailed checklist is provided in the portal to guide applicants through the submission process.

Benefits for Stakeholders:

This new provision is expected to significantly reduce the complexity and time required for regulatory approvals, making it easier for businesses to import medical devices and IVDs into India. By separating the subsequent importer process from other applications, CDSCO aims to facilitate faster approvals and support the growth of the medical device industry.

How to Access the New Feature:

Stakeholders can access the new provision through the CDSCO online portal at https://cdscomdonline.gov.in. The portal provides all necessary guidelines and checklists to ensure a smooth application process.

Conclusion:

The introduction of the “Subsequent Importer” provision reflects CDSCO’s commitment to modernizing the regulatory framework for medical devices in India. This initiative not only simplifies the importation process but also promotes transparency and efficiency, benefiting both businesses and healthcare providers.

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Source: CDSCO

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