Form MD-14 is the standard application for grant of import license under the Medical Devices Rules, 2017. It replaced older fragmented processes with a centralized digital system managed by CDSCO in New Delhi.
The form requires details about the importer, foreign manufacturer, device specifications, and supporting documents from the country of origin. Successful approval results in Form MD-15, the import license itself. This framework regulates the entry of medical devices ranging from low-risk consumables to high-risk implants.
In June 2026, the Union Health Ministry proposed amendments to shorten licensing timelines. For Class B devices, the grant period was reduced from 140 to 115 days. Class C and D devices now target 90 days instead of 105 days.
Applications are filed exclusively through the CDSCO SUGAM portal. Required documents include Power of Attorney, Free Sale Certificate from reference country, ISO 13485 certification, technical dossier, and labeling samples. Fees vary by device class and number of sites, starting from $1,000 per site for Class A devices.
The system allows for query responses within 30 days, with perpetual validity upon payment of retention fees every five years.
Streamlined Form MD-14 processes benefit legitimate importers by reducing market entry time for essential medical devices. This supports India’s growing healthcare sector while maintaining rigorous safety checks.
Manufacturers and importers gain predictability in regulatory timelines, encouraging investment in compliant supply chains. Patients benefit from faster access to approved, high-quality devices from global sources.
The changes also strengthen oversight against substandard imports, aligning with broader government efforts to promote quality manufacturing under Make in India initiatives.
Importers should register on the SUGAM portal and prepare a complete dossier before submission. After filing, CDSCO assigns a reviewer who may raise queries for clarification.
Approved licenses are issued electronically. Retention fees must be paid periodically to keep the license active. Future updates may further digitize verification steps or expand reference country lists.
Stakeholders can submit feedback on proposed amendments to CDSCO for consideration in final rules.
Commonly Asked Questions
What is the primary purpose of Form MD-14?
Form MD-14 is used to apply for an import license for medical devices already approved in recognized reference countries.
How long does Form MD-14 approval take?
Timelines have been shortened to 90-115 days depending on device class under 2026 proposals, subject to complete documentation.
What documents are essential for MD-14 submission?
Key documents include Free Sale Certificate, technical file, quality management certificates, and Power of Attorney from the foreign manufacturer.
Who needs to file Form MD-14?
Indian importers or authorized agents representing foreign manufacturers must file through the SUGAM portal.
Is the import license valid indefinitely?
The license has perpetual validity with payment of retention fees every five years as per the rules.
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