India’s regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has published an important update to streamline subsequent importer applications for medical devices and in vitro diagnostics (IVDs). It allows medical device companies to reach a greater market area by appointing multiple importers and shortens the market entry time for the device.
We’ve also explained the overall process in a separate piece on CDSCO Medical Devices Regulations in India. Now, let us understand about the new CDSCO Brand Endorsement Update for Subsequent Importers of Medical Devices.
Subsequent Importer for Devices Under CDSCO
If a particular medical device or IVD of a foreign manufacturer is already approved in India for import and sale by one Indian authorized agent (IAA)-Importer/Distributor, and if another importer seeks import approval for the same device from the same foreign manufacturer in India, the second importer will be a subsequent importer for the same device.
Also Read: Medical Device Approval Licenses Issued by CDSCO
What is the New Update for the Subsequent importer in India?
CDSCO has published a new circular MED-13011/16/2025-eoffice, providing a separate provision for subsequent importers for medical devices in India, effective from September 11, 2025, on the CDSCO online portal to increase transparency and accountability in the regulatory procedures.
The new update from CDSCO introduces “Tool Tips” published by the CDSCO in the online portal for clarifications regarding regulatory requirements, leading to streamlining the approval procedures with the CDSCO.
Additionally, it has simplified the “Brand Approval” procedures and separated them from the routine endorsement applications, which reduces the application approval timelines, along with the documentation requirements, and expedites the approval of the products.
A separate provision for the subsequent importer has been made, and the applicant can now apply for “Brand Endorsement” in the CDSCO medical devices online portal for the import of already approved medical devices or IVDs. It streamlines the medical device market access procedures by replacing the previous full approval procedure, avoiding duplication, and expediting the market entry time of the devices.
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Impact of the new agreement on further regulatory strategies
- Streamlined regulatory procedures – The subsequent importer can now apply under the Brand Endorsement section without going through the lengthy full approval procedures.
- Faster approval of the products – Streamlining of the approval procedures and reducing the documentation requirements for the subsequent importers, the review of the applications is expedited, which facilitates faster approval of the products.
- Quicker access to the patients – By reducing the overall approval timelines for the medical devices, it enables quicker access to the products for the patients by ensuring the safety and quality of the products.
- Greater Market Reach – The manufacturers can expand the reach of their product with multiple Indian Authorised Agents/importers, avoiding regulatory delays and faster market entry with wider product access to patients.
- Independent License Holding- Foreign manufacturers can have independent policy towards appointing Indian Authorized Agents (IAA) and distributors/ importers by performing full registration through regulatory expert companies who act as IAA while perform market functions of importation or distribution through multiple companies using subsequent importer function. This would allow flexibility in handling market dynamics where as maintaining independent regulatory approach.
Why does this new update matters for Manufacturers and Importers?
This update is significant for foreign manufacturers seeking to widen their market reach in India. With this update, manufacturers can efficiently reach great market areas and easily enhance product availability by strategically planning the regulatory procedures. It also strengthens the manufacturer’s presence in the market against competitors through easy market entry and the availability of the product by appointing multiple importers.
Before this update, subsequent importers were required to go through the full approval procedures for importing the device into India. With the brand endorsement option, this new update simplifies the market entry process for already approved devices by reducing the approval timelines and document requirements, offering a great benefit to subsequent importers for importing the devices into India.
Also Read: Latest Updates In CDSCO’s FDCs List
Key Highlights of the CDSCO New Update
- Transparency and accountability – CDSCO has published several tool tips to provide additional clarity on document requirements for submission of applications to CDSCO.
- Simplification of brand approval procedures – The brand approval procedures are separated from routine endorsement procedures, reducing the document requirements and approval timelines for subsequent importer applications to import the already approved devices in India.
- Introduction of Brand Endorsement under the CDSCO Portal – Brand endorsement provides a separate provision for subsequent importers to import already approved medical devices and IVDs in India, streamlining their approval procedures.
Conclusion
CDSCO has introduced a streamlined regulatory pathway for subsequent importers, facilitating expedited approvals of the medical devices and quicker market access to the products. It marks a significant update for the industry stakeholders to widen the market reach of the product in India.
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