India Pharma Outlook Team | Thursday, 05 February 2026
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document to support IVD medical device importers in filing import license applications through its online systems.
The transition is meant to facilitate the process of submissions and minimize delays through a clear description of how the application should be made under the CDSCO Medical Devices Online Portal and the National Single Window System (NSWS).
The drug regulator argues that the guidance is to assist the importers in filing complete and accurate applications by stating the information to be provided in specific parts of the form. The paper gears all the application steps to the official checklist to streamline approval quicker and in time.
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The draft guidance on IVD import license application issued by the CDSCO has been made in the public domain with the stakeholders requested to make a comment or suggestion within 15 days after it was posted on the CDSCO site on February 2.
The document provides the description of the framework of the applicable regulation according to the Medical Devices Rules, 2017 (MDR-2017), as well as the steps of procedure, documentation requirements, and compliance. It provides two important application routes, which include Form MD-14 to be used in the grant of import license of IVD medical equipment and Form MD-16 to use when importing equipment intended to conduct clinical investigation, testing, evaluation, demonstration, or training.
Under the MD-14, applications are necessary to be made via the site and MD-16 applications are made via the NSWS portal. The guidance also provides the internal review flow, which includes the responsibilities of the review officer, nodal officer, deputy decision authority, and licensing authority and how queries are brought up and addressed and ultimately approved.
With this end to end layout, CDSCO draft guidance on the process of filing the IVD license import should offer more clarity and uniformity to importers who have to go through India medical devices regulatory system.
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