MD 15 License for Medical Devices – Expert Consulting Services
What is an MD 15 License?
An MD 15 license is an official import permit issued by India’s Central Drugs Standard Control Organization (CDSCO), allowing companies to import medical devices into the country. It’s a mandatory requirement for manufacturers or importers intending to bring medical devices to the Indian market under the Medical Device Rules, 2017 (MDR 2017).
Without an MD 15 license, no entity can legally import medical devices for commercial distribution or clinical use in India.
Who Needs an MD 15 License?
If your business involves importing any class of medical devices into India, you’ll require an MD 15 license. This includes:
- Overseas manufacturers supplying medical devices to Indian distributors or healthcare facilities.
- Indian importers or authorized agents representing foreign manufacturers.
- Companies seeking market entry for regulated medical devices in India.
How to Apply for an MD 15 License
The application process for an MD 15 license is managed through the CDSCO’s online SUGAM portal. Here’s an outline of the steps involved:
Step 1 – Device Classification
Confirm the classification of your medical device as per MDR 2017 into Class A, B, C, or D.
Step 2 – Appoint an Authorized Indian Agent (If Applicable)
Foreign manufacturers must appoint an authorized agent or licensed importer in India who holds a valid Form MD-14 application.
Step 3 – Prepare Documentation
Compile mandatory documents such as:
- Plant Master File (PMF)
- Device Master File (DMF)
- ISO 13485 certificate
- Free Sale Certificate (FSC)
- Label artwork and packaging details
- CE certificate or equivalent (if available)
- Plant Master File (PMF)
Step 4 – Submit Application via SUGAM Portal
Apply online on the CDSCO’s SUGAM portal by submitting Form MD-14 (by the importer/agent) and corresponding Form MD-15 for license issuance.
Step 5 – Review & Approval
The CDSCO reviews submitted dossiers, device details, and compliance documents before issuing the MD 15 license for approved applications.
Documents Required for MD 15 License
Mandatory Documents Include:
- Application Cover Letter
- Duly filled MD-14 form (from importer)
- Plant Master File (PMF)
- Device Master File (DMF)
- Free Sale Certificate (FSC) from the country of origin
- ISO 13485 Certificate
- CE Certificate (if applicable)
- Legal agreement between manufacturer and Indian importer/agent
- Product labels and artworks
Post-Approval Compliance for MD 15 License
After obtaining the MD 15 license, importers must:
- Maintain import and distribution records.
- Report adverse events (vigilance reporting) to CDSCO.
- Ensure product labelling complies with Indian labelling regulations.
- Renew the license periodically as per CDSCO guidelines.
Why Choose Operon Strategist for Your MD 15 License?
Operon Strategist is a trusted regulatory consulting partner with over a decade of experience in securing MD 15 licenses and managing complex medical device approvals in India. Our expert team ensures fast, compliant, and hassle-free licensing for global and Indian clients.
What We Offer:
Complete Documentation & Dossier Support
Accurate Device Classification Guidance
SUGAM Portal Application Handling
Regulatory Representation for Overseas Clients
Post-License Compliance & Vigilance Support
More Than Licensing:
Beyond MD 15, we offer end-to-end services for medical device registrations (India, FDA, CE, EDA, SAHPRA), ISO 13485 consulting, plant layout design, and market feasibility studies, making us your complete regulatory partner.
Partner with Operon Strategist for reliable, expert-led regulatory solutions.
Need Expert Guidance for Your MD 15 License Application?
FAQs
How long does it take to get an MD 15 license?
Typically, CDSCO processes MD 15 applications within 45–90 working days, depending on the device classification and dossier completeness.
Is it mandatory for foreign manufacturers to appoint an agent in India?
Yes. Foreign manufacturers must appoint an authorized Indian agent holding a valid MD-14 application to apply for an MD 15 license on their behalf.
Does every medical device need an MD 15 license?
Yes, if you intend to import any medical device into India for sale or clinical use, an MD 15 license is mandatory.