IVD Import Licence (CDSCO Form MD-15)
Before you import in vitro diagnostic kits, reagents or analysers into India, you need an import licence in Form MD-15 from the Central Licensing Authority at CDSCO. You apply in Form MD-14 on the CDSCO online portal, and the rules give the authority up to nine months to decide. We prepare the dossier, file it and handle queries until the licence is issued.
What it is
An in vitro diagnostic (IVD) device is anything used to test samples taken from the human body, such as blood, urine or swabs, outside the body. Rapid test cards, ELISA kits, reagents, calibrators and controls are IVDs, and so are the analysers that run them. In India they are regulated as medical devices. Bring them in from abroad, and you need an import licence first.
The law is the Medical Devices Rules, 2017, made under the Drugs and Cosmetics Act, 1940. Under Rule 34 the manufacturer’s authorised agent in India applies in Form MD-14. Under Rule 36 the Central Licensing Authority (the Drugs Controller General of India, at CDSCO) grants the licence in Form MD-15. Applications are filed online on the CDSCO medical devices portal (cdscomdonline.gov.in), which is also reachable through the National Single Window System.
Who it applies to
Distributors of diagnostic kits
Indian companies, LLPs or firms that buy IVD kits and reagents from a foreign manufacturer and sell them to labs, hospitals and pharmacies. Think of a Faridabad trader who supplies pathology labs across NCR and wants to add a European ELISA range.
Indian arms of foreign manufacturers
A subsidiary or liaison set-up that acts as the authorised agent for its overseas parent and holds the licence on its behalf.
Analyser and reagent suppliers
Businesses that place instruments in labs and supply the matching reagents, controls and calibrators, each of which needs to be covered.
Why it matters
Customs will not release the goods
IVDs can only be imported through ports notified under the Drugs Rules, 1945, where CDSCO port officers check the licence before clearance.
Hospitals and tenders ask for it
Hospital buyers and government tenders ask for a copy of the MD-15 that covers the exact product and manufacturing site.
The licence does not lapse
Under Rule 37 the licence stays valid until it is suspended or cancelled, as long as the retention fee is paid after every five years.
Documents required
From the Indian importer
- Wholesale licence, manufacturing licence or registration certificate in Form MD-42
- Company or firm constitution documents and GST registration
- Import Export Code from DGFT
- Details of storage premises
From the foreign manufacturer
- Power of attorney appointing the Indian agent, authenticated by a magistrate, the Indian embassy or apostille
- Free Sale Certificate naming the legal and the actual manufacturer
- Quality management system certificate for the site
Product dossier
- Plant Master File and Device Master File as per the Fourth Schedule
- Labels and instructions for use
- Performance evaluation data, where the class of the kit requires it
- Risk class of each product as per CDSCO’s IVD classification list
How it works
Classify every kit against CDSCO’s list
We match each product to CDSCO’s published IVD classification list and confirm whether it is Class A, B, C or D. The class decides the fee. It also decides how closely the file is reviewed.
Get your Indian licences in place
The applicant must already hold a wholesale licence, a manufacturing licence or an MD-42 registration. If you have none, we start with your wholesale drug licence and your Import Export Code.
Build the dossier with the manufacturer
We send the manufacturer a checklist for the power of attorney, Free Sale Certificate, Plant Master File and Device Master File. Here is the catch: most delays start with one missing line, such as the actual manufacturer’s address on the Free Sale Certificate. So we review each document before it is uploaded.
File Form MD-14 and pay the fee
We register you on the portal, file MD-14 and pay the Second Schedule fee online.
Answer queries until MD-15 is issued
CDSCO reviewers often raise queries. We draft replies with the manufacturer’s regulatory team and track the file until the licence is granted.
Government fee by risk class
| IVD class | Per manufacturing site | Per product |
|---|---|---|
| Class A | USD 1,000 | USD 10 |
| Class B | USD 1,000 | USD 10 |
| Class C | USD 3,000 | USD 500 |
| Class D | USD 3,000 | USD 500 |
These are the Second Schedule fees as stated in CDSCO’s IVD FAQ, payable in the rupee equivalent. In practice, the site fee is a one-time cost per site: adding a product from the same site later costs only the product fee. Say a Gurugram distributor already imports Class B rapid tests from one plant and wants two more Class B kits from that plant. It pays USD 10 per kit, not a fresh site fee.
Timelines
Decision within nine months
Rule 36(1) gives the Central Licensing Authority nine months from the date of application to grant or reject the licence.
Retention fee every five years
The licence remains valid in perpetuity, but Rule 37 requires the retention fee after completion of every five years.
Report changes on time
Major changes listed in the Sixth Schedule need prior approval. Minor changes are notified within 30 days of making them.
What happens if you import without a licence
Your shipment sits at the port
Without an MD-15 covering that product and that site, the port office will not clear the consignment. Demurrage keeps adding up every day it waits.
Action under the Act
Importing a regulated device without a licence is an offence under the Drugs and Cosmetics Act, 1940, and the goods can be seized.
Buyers can reject the supply
A lab chain or tender authority can reject kits that are not covered by a valid licence. A licence for a similar kit from a different site does not count.
Frequently asked questions
Who can apply for an IVD import licence?
Only an Indian entity acting as the authorised agent of the foreign manufacturer can apply. Under the Medical Devices Rules, 2017, that agent must hold a valid wholesale licence, a manufacturing licence, or a registration certificate in Form MD-42. A private limited company, LLP, partnership or proprietorship can all qualify if they hold one of these. More than one Indian agent can hold separate licences for the same manufacturer’s product.
How long does CDSCO take to issue Form MD-15?
The rules allow the Central Licensing Authority up to nine months from the date of application. That is the outer limit under Rule 36(1), not a fixed wait. A complete dossier and quick replies to queries decide how soon the licence comes through. We keep the manufacturer’s regulatory team on a shared checklist, so a query does not sit unanswered for weeks.
Is the IVD import licence valid for a fixed period?
No, the MD-15 licence stays valid until it is suspended or cancelled. Rule 37 makes it perpetual on one condition: the licence retention fee must be paid after completion of every five years. Keep a calendar entry for the five-year date, because the licence depends on that payment being made on time.
Which countries’ Free Sale Certificates does CDSCO accept for IVDs?
CDSCO’s IVD FAQ lists Free Sale Certificates from Australia, Canada, Japan, the European Union countries, the United Kingdom and the USA. The certificate must name both the legal manufacturer and the actual manufacturer with addresses. A certificate of exportability is not accepted in its place. If your manufacturer sits elsewhere, talk to us early so we can plan the documents.
Do I need a separate licence for every kit?
Not always. One MD-15 covers a manufacturing site and the products listed on it. More products from the same site can be added by endorsement, paying only the per-product fee of USD 10 for Class A or B and USD 500 for Class C or D. A new manufacturing site needs its own site fee.
Can I import a few kits for evaluation before the licence?
Yes, through a test licence. You apply in Form MD-16 and receive a licence in Form MD-17, which allows small quantities for clinical investigation, test, evaluation, demonstration or training. The fee is USD 100, the authority decides within 30 days under Rule 41, and the licence is valid for three years. These kits cannot be sold, so keep a record of where each one went.
Can Indian labelling be added after the kits land?
Yes. CDSCO allows the importer to add India-specific details by stickering, as long as the final label meets Chapter VI of the Medical Devices Rules, 2017. The label must show both the date of manufacture and the expiry date or shelf life. Plan the sticker content with us before the first shipment so the port check goes smoothly.
What if the foreign manufacturer changes its name or is acquired?
It depends on the size of the change. CDSCO treats a merger or acquisition that shifts more than 50% of voting capital as a change of constitution, which needs a fresh import licence. A plain change of name or address is notified within 45 days. We review each change and tell you which route applies.
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.
The government fee depends on the risk class and on how many products and sites you list (see the table above). The retention fee then falls due after every five years. Fees are paid online on the CDSCO portal.
Our role
We handle the regulatory side: the eligibility check, the dossier checklist, portal filing and fee payment, query replies, and later the retention fee and change notifications. Performance evaluation is carried out by laboratories recognised for the purpose, and technical files such as the Device Master File come from the manufacturer. We coordinate with both but do not run a testing lab ourselves.
Ready to begin?
Send us your product list and the manufacturer’s details, and we will tell you the class, the fee and the documents needed for your MD-15.