Who Can Apply for Medical Device Import License in India?

An Indian importer or an Indian Authorized Agent representing a foreign manufacturer can apply for a medical device import license in India. Under the Medical Device Rules, 2017, the Central Drugs Standard Control Organization (CDSCO) requires applicants to submit the import license application through the CDSCO SUGAM portal.

Foreign manufacturers cannot directly apply for an import license. Instead, they must appoint an Indian Authorized Agent who submits the application, manages regulatory communication, and ensures compliance with CDSCO requirements. Therefore, selecting a qualified regulatory representative becomes a critical step in the approval process.

Typically, the following entities can apply for a medical device import license:
i).Indian importers holding a valid wholesale drug license
ii). Indian Authorized Agents appointed by foreign manufacturers
iii). Indian subsidiaries of global medical device manufacturers

Before submitting the application, the applicant must prepare all required documents for medical device import, including:
i). Power of Attorney from the manufacturer
ii). ISO 13485 Certificate
iii). Free Sale Certificate
iv). Device Master File (DMF)
v).Plant Master File (PMF)
vi). Labeling documents compliant with MDR 2017
vii). Wholesale license of the Indian Authorized Agent

Once the applicant compiles these documents, they must submit Form MD14 through the CDSCO SUGAM portal. Subsequently, CDSCO evaluates the application, reviews technical documentation, and may raise regulatory queries if clarification is required.

After successful review and compliance verification, CDSCO grants the MD15 import license, which legally allows the importer to import and distribute the medical device in India.

However, many importers face challenges related to device classification, documentation accuracy, and CDSCO query responses. Consequently, foreign manufacturers often collaborate with experienced regulatory consultants to ensure compliance and avoid approval delays. Companies entering the Indian market can explore professional medical device import license services in India offered by Regacats Solutions as a CDSCO Consultant to streamline documentation preparation, regulatory submissions, and CDSCO communication.

Furthermore, applicants who want to understand the full regulatory framework should review the detailed medical device import license guide that explains classification, documentation requirements, and the complete MD14-MD15 approval process in India.