CDSCO Import License for Medical Devices: Form MD-14 to MD-15 Process Explained
A procurement officer at the hospital you’re bidding for asks a simple question during due diligence: “What’s your import license number?” You don’t have one. You’ve got a customs code, a Free Sale Certificate, and a device that’s already cleared for sale in three other countries. None of that answers the question she’s actually asking, and the bid stalls right there.
This mix-up happens more than you’d think. A lot of importers assume “CDSCO registration” is one process with one outcome. They file a registration, and only find out at the tender or customs stage that their device also needed a license. So, let’s walk through what a CDSCO import license is, who needs one, and how the Form MD 14 to Form MD 15 process works. We’ll also cover how it fits with establishment registration & device listing, which is a separate and earlier step.
What Is a CDSCO Medical Device Import License?
The Central Drugs Standard Control Organisation (CDSCO), acting through the Drugs Controller General of India (DCGI) as the Central Licensing Authority, licenses medical device imports into India. Medical devices are legally treated as “drugs” under the Drugs and Cosmetics Act, 1940. The operative rulebook is the Medical Device Rules, 2017 (MDR 2017), in force from 1 January 2018.
A CDSCO medical device import license is the formal permission an importer, or a foreign manufacturer’s authorised agent in India, needs before a regulated device can legally be imported and sold or distributed in the country. The application is made on Form MD 14 (often written Form MD-14), and the license is granted on Form MD 15 (Form MD-15).
You’ll see this requirement described in several ways: CDSCO import license, import licence for medical devices, import license CDSCO expects before customs will release a shipment, or the MD 15 license. They all point to the same Form MD-14 to MD-15 process. The phrasing just hasn’t settled across government forms and trade documentation.
“CDSCO import registration” is the loosest of these terms. It can mean the Chapter IIIA registration an importer files for a non-notified device, or it can mean the license. These are different steps, and the next section explains how they relate.
Registration and License: Two Stages, Not Two Competing Tracks
CDSCO’s framework works differently depending on where your device started.
Devices on CDSCO’s original notified list (37 categories). These were already under CDSCO licensing and are exempt from Chapter IIIA registration. For these, you apply directly for the import license on Form MD-14.
Devices that were previously non-notified. These now follow two stages:
- Registration. Under Chapter IIIA of the MDR 2017 (Rules 19A–19C), importers upload device details, including the Free Sale Certificate, on CDSCO’s Online System for Medical Devices. A registration number is generated, and this is what’s commonly called establishment registration & device listing. Registration was voluntary from 1 April 2020 to 30 September 2021 and mandatory from 1 October 2021.
- Licensing. Class A and B devices moved to the licensing regime from 1 October 2022, and Class C and D from 1 October 2023. Licensing means the Form MD-14 / MD-15 import license described below.
Those dates have passed, so the practical position today is this: an importer of any device class needs the import license. A registration number on its own does not authorise import. If you only hold a registration, you’ve likely completed the first stage but not the second.
Who Needs a CDSCO Import License
- Importers bringing a regulated medical device into India for sale, distribution, or use
- Foreign manufacturers exporting devices into the Indian market, whether directly or through a distributor
- Indian subsidiaries of overseas manufacturers, where the subsidiary is the entity of record for the import
- Distributors acting as importer of record, where the license needs to sit under their name rather than the manufacturer’s
If you’re unsure where your device sits, check its risk class and its status against CDSCO’s current lists before filing. Don’t rely on how it was categorised in another country.
Foreign Manufacturers Without an Indian Office: Why You Need an Authorised Agent
If you manufacture overseas and have no registered presence in India, the application is filed through an Authorised Agent. This is an India-based entity appointed under a Power of Attorney that holds a valid wholesale license, manufacturing license, or Form MD-42 registration certificate. The agent files the application, responds to CDSCO’s queries, and stands as the accountable presence in India for the device.
Choosing the wrong agent, one who is unresponsive or unfamiliar with how CDSCO reviews import applications, is a common reason this process drags on. EXIM ADVISORY takes on this role for manufacturers with no presence of their own in India.
The CDSCO Import License Process: Form MD-14 to Form MD-15, Step by Step
- Confirm your route. Check whether your device is on the original notified list or previously non-notified. If it is non-notified, confirm that your Chapter IIIA registration is in place, and identify your risk class.
- Appoint your Authorised Agent, if you’re a foreign manufacturer without an Indian office. This must be done before the application can move forward.
- Compile your technical documentation. This includes the Device Master File, Plant Master File, Free Sale Certificate, ISO 13485 certificate, test reports, and labeling and Instructions for Use.
- File Form MD-14. Submit it through CDSCO’s online licensing system with the technical file and the fee challan.
- Respond to review queries. It’s uncommon for an application to pass untouched on the first review. Reviewers often ask for a clarified test parameter, an updated Free Sale Certificate, or a labeling correction.
- Receive your import license on Form MD-15, carrying a unique license number. Customs, distributors, and procurement teams commonly ask for it.
Import License Validity, Retention & Post-License Compliance
An import license on Form MD-15 is issued in perpetuity, but only if the license retention fee is paid every five years from the date of issue and license conditions continue to be met. CDSCO allows a 90-day window after the due date, with a late fee. If retention lapses beyond that, the license can cease to be valid.
Other things to keep current once you’re licensed:
- Any change to your Authorised Agent, manufacturing site, or device specification must be reflected through the prescribed CDSCO process. It doesn’t update automatically.
- Adding a device under the same license generally requires an endorsement application, filed on Form MD-14 and mapped to the base license.
- Serious adverse events connected to your imported device must be reported to CDSCO and the Materiovigilance Programme of India (MvPI). This is a standing obligation while the license is active.
Documents Required for a CDSCO Medical Device Import License
Requirements vary by device and by whether you file as a subsidiary or through an Authorised Agent. Across most applications, keep these ready:
- Form MD-14 application with covering letter and fee challan
- Power of Attorney and Authorised Agent appointment documents, for foreign manufacturers
- Wholesale license, manufacturing license, or Form MD-42 registration certificate of the Authorised Agent
- Free Sale Certificate from the regulatory authority of the country of origin, properly attested
- ISO 13485 certificate covering the manufacturing site
- Regulatory approval from a reference market where applicable, such as a CE certificate or US FDA clearance
- Device Master File and Plant Master File
- Test reports, and clinical evaluation data where the device warrants it
- Labeling, packaging inserts, and Instructions for Use
- Undertaking or declaration of compliance as prescribed under CDSCO’s requirements
An incomplete Free Sale Certificate or a labeling mismatch against the declared specification is a common reason an otherwise solid application is sent back for revision.
What Happens If You Import Without a Valid CDSCO License
Because medical devices are legally classified as drugs, importing a regulated device without a valid import license falls under the Act’s import provisions (Section 13). Selling or distributing unlicensed devices can also attract penalties under Section 27, which Article 1’s penalty discussion covers. CDSCO and customs authorities also have powers to detain shipments, seize non-compliant stock, and refer serious cases for prosecution.
Most importers feel the practical consequences first. Customs commonly asks for the license number tied to the device, and unlicensed shipments risk detention. Distributors increasingly ask for it before carrying a product, and hospital procurement teams often require it for tenders. We’ve seen deals stall because the importer held a registration and assumed it covered an import license. It didn’t.
Why Choose EXIM ADVISORY
We don’t treat this as a form-filing exercise separate from the rest of your compliance picture. We handle establishment registration & device listing alongside import licensing, plus the customs and DGFT work around a medical device import. Your registration, license, and port clearance are managed as one continuous compliance thread.
We’ve worked with manufacturers who assumed registration was the only CDSCO step they needed, and learned at the tender stage that they also needed an import license. We tell clients up front which steps their device requires, and we start the technical file early so it doesn’t become the reason a launch or tender slips.
Frequently Asked Questions
What is a CDSCO medical device import license?
It’s the formal authorization, granted on Form MD-15 after an application on Form MD-14, that permits a regulated medical device to be imported into and sold or distributed within India.
What’s the difference between a CDSCO import license and establishment registration & device listing?
Establishment registration & device listing is the Chapter IIIA registration for previously non-notified devices, and it generates a registration number. The import license is a separate, later requirement. Registration alone does not authorise import.
Is CDSCO import registration the same as an import license?
No. “CDSCO import registration” is a loose term that can mean the Chapter IIIA registration or the license. Only the license on Form MD-15 authorises import.
What is Form MD 14?
Form MD 14 (Form MD-14) is the application for a CDSCO import license. It is filed with supporting technical documentation and the fee challan, and it is also used for endorsement applications to add devices.
What is Form MD 15?
Form MD 15 (Form MD-15) is the import license itself, issued once the Form MD-14 application is reviewed and approved. It carries a unique license number.
Who needs to appoint an Authorised Agent?
Foreign manufacturers without a registered office in India. The agent must hold a valid wholesale license, manufacturing license, or Form MD-42 registration certificate.
How long is a CDSCO import license valid?
It is issued in perpetuity, provided the retention fee is paid every five years and license conditions are met.
Can I import a medical device into India without a CDSCO license?
No. Importing without a valid license risks shipment detention, penalties under the Drugs and Cosmetics Act, and a stalled distributor or procurement relationship.
How long does it take to get a CDSCO import license?
It depends mainly on how complete your first submission is. An incomplete Free Sale Certificate or a labeling inconsistency is the most common cause of delay.
Get Your Medical Device Import License Sorted With EXIM ADVISORY
A device approved everywhere else in the world still can’t move through Indian customs without the right CDSCO paperwork, and a registration alone won’t fix that at the distributor stage or the port. Talk to EXIM ADVISORY before your next shipment leaves origin. We’ll confirm which steps your device needs, take on the Authorised Agent role where required, and get your Form MD-14 filing moving before a stalled deal forces the issue.