CDSCO Import Licence for Medical Devices in India (MD-14 & MD-15): Process, Documents, Cost & Timeline — 2026 Guide

Every medical device or in-vitro diagnostic (IVD) that is manufactured abroad and sold in India needs one central approval before a single unit can clear customs: a CDSCO import licence in Form MD-15. Whether you are a foreign manufacturer entering the Indian market or an Indian distributor bringing in a device brand, the import licence is the legal gate — and it is granted centrally by the Central Drugs Standard Control Organisation (CDSCO), regardless of the device's risk class.

Import licensing is where many companies lose months. Unlike domestic manufacturing (licensed at State level for Class A and B), import of any class — A, B, C or D — is licensed centrally through CDSCO's SUGAM portal, and it must be filed by an Authorised Indian Agent. This guide explains, in plain terms, how the MD-14 to MD-15 route works, who can apply, the documents CDSCO actually checks, the real cost drivers and timeline, and how MedRegX manages the entire process for you.

What is a CDSCO import licence for medical devices?

A CDSCO import licence is the central authorisation, issued under the Medical Device Rules, 2017, that lets a notified medical device or IVD be legally imported and sold in India. The device is first classified as Class A (low risk), B (low–moderate), C (moderate–high) or D (high risk), and the import application is then filed on the CDSCO SUGAM portal. Once granted, the licence is issued in Form MD-15 and lists every device, variant and accessory it covers.

Two points trip up first-time importers. First, the risk class does not change who licenses the import — CDSCO handles all classes for import, even Class A. Second, the foreign manufacturer cannot hold the licence; it is always held by an Indian entity acting as the Authorised Indian Agent.

Form MD-14 vs Form MD-15 — application and licence

The two forms are often confused, but they are distinct stages of the same process:

Who can be the importer? The Authorised Indian Agent

CDSCO grants the MD-15 licence only to an Indian entity — the Authorised Indian Agent — that holds one of the following: a valid manufacturing licence, a wholesale/sale licence in Form 20B/21B (or the device equivalent), or a CDSCO registration. The foreign manufacturer issues a power of attorney authorising this agent to represent it before CDSCO, handle regulatory correspondence, and take responsibility for the imported product in India, including post-market obligations and recalls.

Choosing the right agent structure matters: the agent's name appears on the licence, receives regulatory notices, and is accountable for materiovigilance. Many manufacturers appoint a specialist regulatory partner as their agent precisely to keep this responsibility in professional hands.

Documents required for an MD-15 import licence

CDSCO reviews the technical dossier closely. The core documents include:

• Device Master File (DMF) — device description, intended use, materials, design and manufacturing details, risk management and validation.
• Plant Master File (PMF) — the manufacturing site's quality system, layout and controls.
• Free Sale Certificate / Certificate to Foreign Government from the country of origin.
• Regulatory approvals — CE Certificate, US FDA 510(k)/PMA, or equivalent, where applicable.
• ISO 13485 quality-management certificate for the manufacturing site.
• Power of Attorney appointing the Authorised Indian Agent.
• Wholesale/manufacturing licence or CDSCO registration of the Indian agent.
• Labels, Instructions for Use (IFU) and, for IVDs, performance-evaluation data.

The import licence process, step by step

1. Classify the device under the CDSCO risk classification and confirm it is a notified device/IVD.
2. Appoint the Authorised Indian Agent and execute the Power of Attorney.
3. Compile the DMF and PMF and gather the free-sale and regulatory certificates.
4. File Form MD-14 on the SUGAM portal with the government fee.
5. Respond to CDSCO queries — the review typically involves one or more deficiency letters.
6. Grant of Form MD-15 — the import licence is issued and the devices can be imported and sold.

Cost and timeline

Government fees are charged per site and per distinct device, and vary by class. Beyond the statutory fee, the real cost drivers are dossier preparation, apostilled/legalised foreign documents, and consultancy. Indicative timelines:

The MD-15 licence is granted in perpetuity, subject to a retention fee every five years — so the heavy lifting is front-loaded into the first application.

Common mistakes that delay MD-15 approval

• Wrong or optimistic classification that CDSCO later reclassifies to a higher risk class.
• Incomplete Device Master File — missing validation, risk management or biocompatibility data.
• Expired or country-mismatched Free Sale Certificate.
• Weak Power of Attorney or an agent whose licence does not cover the device category.
• Labels and IFU that do not meet Indian labelling requirements.

Import licence vs domestic manufacturing licence

It is worth being clear on how importing differs from making a device in India, because the two routes are governed differently and companies often mix them up:

The practical takeaway: for imports, the quality of your documentation is what wins or loses the approval, because CDSCO cannot physically inspect a factory in another country.

Importing an IVD — what is different

In-vitro diagnostics follow the same MD-14 to MD-15 route, but the dossier expectations shift toward analytical and clinical performance evaluation. CDSCO looks closely at sensitivity and specificity data, stability studies, and — for higher-risk IVDs such as those used to screen blood or diagnose serious conditions — evidence generated or validated for the Indian context. Building this evidence early, and mapping it to CDSCO's expectations, is the single biggest lever on an IVD import timeline.

After you get MD-15: your ongoing obligations

The import licence is the start, not the finish. Once MD-15 is granted, the Authorised Indian Agent must keep import records, ensure India-compliant labelling and Instructions for Use, report adverse events under the Materiovigilance Programme of India (MvPI), handle field-safety corrective actions and recalls, and pay the five-yearly retention fee to keep the licence alive. Any new variant, accessory or manufacturing-site change generally needs a licence amendment before it can be imported.

How MedRegX handles CDSCO import licensing end-to-end

MedRegX manages the full MD-14 to MD-15 journey: correct device classification, acting as or coordinating your Authorised Indian Agent, building an audit-ready Device Master File and Plant Master File, filing on SUGAM, and closing every CDSCO query until the import licence is granted. We also keep you compliant after grant — labelling, MvPI reporting, amendments and retention fees. With eight years of hands-on CDSCO experience across medical devices and IVDs, we make a process that frustrates most importers predictable and time-bound.

CDSCO import licence support across India

We support importers and Indian agents nationwide — including Delhi NCR, Mumbai, Bengaluru, Hyderabad, Chennai, Ahmedabad and Pune — with the same central CDSCO filing. Explore our CDSCO compliance services and medical device import support to see how we can shorten your route to market.

Frequently asked questions

What is a CDSCO import licence for medical devices?

It is the central licence, granted by CDSCO under the Medical Device Rules, 2017, that legally permits a notified medical device or IVD to be imported into India. The importer applies in Form MD-14 through an Authorised Indian Agent and, on approval, receives the import licence in Form MD-15.

What is the difference between Form MD-14 and Form MD-15?

Form MD-14 is the application you submit on the SUGAM portal to import a device; Form MD-15 is the import licence CDSCO issues once the application, Device Master File and Plant Master File are accepted. MD-15 is the document that actually authorises import and customs clearance.

Who can apply for a CDSCO import licence?

Only an Authorised Indian Agent — an entity based in India that holds a valid manufacturing or wholesale licence, or a CDSCO registration — can file the MD-14 application on behalf of the foreign manufacturer. A foreign company cannot hold an MD-15 licence directly.

How long is an MD-15 import licence valid?

An import licence in Form MD-15 is granted in perpetuity and remains valid as long as the retention fee is paid every five years and the licence conditions are met, so long as it is not suspended or cancelled.

How long does it take to get an MD-15 licence?

For most Class A and B devices, expect roughly 6 to 9 months, and 9 to 12 months for Class C and D devices, depending on the completeness of the Device Master File, the free-sale/regulatory status certificates, and CDSCO query cycles.