Medical Device Import Licence (Form MD-15) in India
A medical device import licence is the CDSCO approval in Form MD-15 that lets an Indian agent bring a foreign-made device into India for sale. You apply in Form MD-14 on the Medical Devices Online portal, and the rules give CDSCO up to nine months to decide. We prepare the dossier with the overseas manufacturer and handle the filing to grant.
What it is
Under the Medical Devices Rules, 2017, nobody may import a medical device for sale or distribution without a licence from the Central Licensing Authority, the Drugs Controller General (India) at CDSCO. The application is Form MD-14 under Rule 34. The licence is Form MD-15. It names the overseas manufacturer, its manufacturing sites and each device you are allowed to import.
The licence covers devices of every risk class, from Class A to Class D, and in vitro diagnostic kits. The one exception is Class A devices that are non-sterile and non-measuring. Those get a free, system-generated registration number on the portal instead of a licence. Applications are filed on cdscomdonline.gov.in, the Medical Devices Online portal, and fees go through Bharatkosh.
Who it applies to
You are an overseas maker’s Indian agent
Rule 34 allows only an authorised agent to apply: a person or firm appointed by the overseas manufacturer through a power of attorney, holding a manufacturing licence or a wholesale licence for sale or distribution.
You are a foreign maker entering India
The overseas company does not apply itself. It appoints an Indian agent, or sets up an Indian private limited company to act as one, and supplies the technical dossier.
You want to import a brand someone else already imports
Importing the same product as another agent is allowed. CDSCO’s FAQ confirms that one product can have several authorised Indian agents, each holding its own licence.
Why it matters
Import within the law
A device imported without a licence is imported in breach of the Drugs and Cosmetics Act, 1940. The MD-15 is your proof that the import is lawful.
Sticker the pack in India
The import licence number, the importer’s name and address and the manufacturing site go on the pack. CDSCO allows importers to add these by sticker in India.
Keep it without renewals
Rule 37 keeps the licence valid in perpetuity. The only condition is a retention fee every five years from the date of issue.
When you need a fresh licence
The MD-15 is tied to a specific agent, manufacturer and site. Some changes need only an endorsement. Others need a new licence. Here is the catch: a partnership importer that converts into a company needs a fresh MD-15, so plan the conversion around it.
Your entity changes form
CDSCO’s FAQ says any change in the constitution of the licence holder needs a fresh import licence application.
The overseas site moves
A change in the location of the overseas manufacturer or its manufacturing site also calls for a fresh application.
You add a site or a device
An additional manufacturing site of the same legal manufacturer can be endorsed on the existing licence with documents and fee. New devices are added the same way.
Documents required
From you, the Indian agent
- Constitution documents, PAN and GST of your entity
- Importer Exporter Code from DGFT
- Your wholesale or manufacturing licence
- Undertaking from the authorised agent in the Fourth Schedule format
From the overseas manufacturer
- Power of attorney, authenticated by a First Class Magistrate in India, the Indian Embassy, or by apostille
- Free sale certificate naming both legal and actual manufacturer
- Plant Master File and quality certificates such as ISO 13485
- Regulatory approvals in other countries, where held
For each device
- Device Master File as per the Fourth Schedule
- Labels and instructions for use
- Test reports and the standards applied
How it works
Settle the Indian class
Classes abroad and in India do not always match. Where they differ, CDSCO may apply the higher class, so we settle this first.
Put the Indian agent in place
You need an Indian entity with an IEC and a manufacturing licence or wholesale drug licence. If you do not have one, we set it up before the import filing.
Collect the overseas dossier
The manufacturer sends the power of attorney, free sale certificate and master files. In practice, allow time here: documents travel, get signed and get authenticated abroad. We check every document against Parts I to III of the Fourth Schedule.
File Form MD-14 and pay
We file on the Medical Devices Online portal and pay the Second Schedule fee for each site and each distinct device.
Answer queries and receive the MD-15
CDSCO reviews the file, raises queries and may inspect the overseas site before or after grant. We draft the replies with you and track the application to the licence.
Timelines
Grant of the licence
Rule 36 gives CDSCO nine months from the date of application, if the documents are satisfactory.
Overseas inspection
Optional, at CDSCO’s choice, before or after grant. If it happens, an extra fee of $6,000 is payable.
Retention fee
Every five years from the date of issue of the licence, under Rule 37.
What happens if you import without a licence
Offence under the Act
Importing a device in breach of Chapter III of the Drugs and Cosmetics Act, 1940 is an offence under Section 13.
Stuck shipments
Without an MD-15 on record, the consignment cannot be lawfully cleared for sale.
Trouble down the chain
Selling an unlicensed device is a separate offence under Section 27, with prison terms and fines.
Frequently asked questions
Who can apply for a medical device import licence?
Only an authorised agent in India can apply. Under Rule 34 of the Medical Devices Rules, 2017, the agent must hold a manufacturing licence or a wholesale licence for sale or distribution, and must be appointed by the overseas manufacturer through a power of attorney. The overseas company cannot apply directly. If you do not yet have a wholesale licence, we can arrange it before the import application.
How long does CDSCO take to grant Form MD-15?
Rule 36 gives CDSCO up to nine months from the date of application, provided the documents are satisfactory. Each query adds a round of replies and more weeks. CDSCO may also inspect the overseas site, before or after grant. We aim to file a complete dossier the first time so queries stay few.
What is the government fee for a Class C device import licence?
For Class C or Class D devices other than IVDs, the Second Schedule fee is $3,000 for each overseas manufacturing site and $1,500 for each distinct device. So one site with two devices costs $6,000. Class C or D IVDs cost $3,000 per site and $500 per kit. We prepare an exact fee sheet before you pay.
Does a Class A device need an import licence?
It depends on the device. A Class A device that is non-sterile and non-measuring does not need an import licence; it gets a free, system-generated registration number on the Medical Devices Online portal. A Class A device that is sterile or has a measuring function does need Form MD-15, at $1,000 per site and $50 per device. We confirm which group your device falls into.
Is a free sale certificate mandatory?
Yes. CDSCO’s FAQ treats the free sale certificate from the country of origin as a required document, and it should name both the legal manufacturer and the actual manufacturer. A certificate of exportability is not accepted in its place. If the device is not sold in its home country, tell us early.
How must the power of attorney be authenticated?
The power of attorney, along with the authorised agent’s undertaking in the Fourth Schedule format, must be authenticated in India by a First Class Magistrate, or by the Indian Embassy in the country of origin, or through apostille. We send the overseas manufacturer the format first, so it is signed and authenticated correctly in one go.
Can more than one Indian company import the same device?
Yes. Picture a Gurugram distributor that wants to import a monitor already brought in by another agent. CDSCO’s FAQ confirms that a manufacturer can appoint more than one authorised Indian agent for the same product. Each agent holds its own MD-15. A later agent files Form MD-14 with its own power of attorney, free sale certificate and fee, a copy of the earlier licence and the manufacturer’s undertaking that the master files have not changed.
What if my device has no predicate device in India?
Then CDSCO normally requires a clinical investigation. Its FAQ says this may be waived if the device is approved in the UK, USA, Australia, Canada or Japan, has been marketed there for at least two years, and CDSCO is satisfied with the safety, performance and vigilance data. The permission fee is ₹50,000 under Rule 63. We assess this before you commit to timelines.
How long is the import licence valid?
It is valid in perpetuity unless it is suspended or cancelled. Under Rule 37, you pay a retention fee every five years from the date of issue, at the same rates as the licence: per overseas site and per distinct device. If the constitution of your entity changes, a fresh licence is needed. We track both events in your compliance calendar.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fees under the Second Schedule of the Medical Devices Rules, 2017 (the same rates apply as the five-yearly retention fee):
| Device | Per overseas site | Per distinct device |
|---|---|---|
| Class A (sterile or measuring, non-IVD) | $1,000 | $50 |
| Class B (non-IVD) | $2,000 | $1,000 |
| Class C or D (non-IVD) | $3,000 | $1,500 |
| Class A or B IVD | $1,000 | $10 |
| Class C or D IVD | $3,000 | $500 |
| Overseas site inspection, if ordered | $6,000 | – |
| Import for test, evaluation, demonstration or training | – | $100 |
Ready to begin?
Share the manufacturer, the device list and its class. We will send the document checklist and the exact CDSCO fee before anything is filed.