Can One MD15 License Cover Multiple Medical Devices in India?

Yes, one MD15 license can cover multiple medical devices in India in certain situations. However, the answer depends on how the products are classified, grouped, and presented during the CDSCO application process.

Under the Medical Device Rules, 2017, medical devices that belong to the same device family, have a common intended use, and meet CDSCO grouping requirements may be included within a single application. As a result, these products can often be covered under one MD15 import license after approval.

However, devices that differ significantly in intended use, risk classification, technology, or product category may require separate applications and separate licenses.

Therefore, before filing an MD14 application, manufacturers and importers should carefully evaluate their product portfolio. Proper device grouping can reduce administrative burden, streamline the review process, and help avoid unnecessary regulatory complications. On the other hand, incorrect grouping may trigger CDSCO queries, additional documentation requests, or application delays.

For foreign manufacturers and Indian importers, determining the correct grouping strategy is often one of the most important steps in the import licensing process. Consequently, many businesses seek support from a CDSCO Medical Device Import License Consultant in India to assess device eligibility, review documentation, and prepare a compliant filing strategy.

In addition, companies should remember that CDSCO evaluates each application based on product characteristics, intended use, risk category, and supporting evidence. Therefore, there is no universal rule that automatically allows all devices to be covered under a single MD15 license.

If you are planning to import multiple medical devices into India, it is advisable to review the complete regulatory pathway before submission. You can also explore our detailed guide on How to Apply for Medical Device Import License in India to understand the overall MD14 and MD15 process. Furthermore, our article on Medical Device Classification India: CDSCO Class A B C D Guide can help you understand how device classification impacts application requirements and approval strategy.

Businesses seeking expert support for classification, documentation, MD14 filing, and MD15 approval can also consult to Regacats Solution for end-to-end regulatory assistance