IVD Import Registration in India: CDSCO IVD Import License for Diagnostic Kits, Reagents and Analysers

What Is IVD Import Registration?

IVD import registration is the CDSCO approval needed before in-vitro diagnostic devices made outside India can be imported for sale. In-vitro diagnostics, or IVDs, are reagents, kits, calibrators, control materials, specimen receptacles, software and instruments used to examine samples taken from the human body, such as blood, urine or swabs, to give information for diagnosis, screening or monitoring. Under the Medical Devices Rules, 2017, IVDs are medical devices, so their import follows the same licence: an application on Form MD-14 by the Indian authorised agent, and an import licence on Form MD-15 granted by CDSCO.

When people search for CDSCO IVD registration, IVD registration in India or in vitro diagnostic medical device registration India for an imported product, this MD-15 licence is what they need. It lists each approved IVD, its class and the overseas manufacturing site. For businesses in India, the licence is central and filed on ONDLS or your state drug licensing portal; the warehouse that stores and sells the kits needs its own state licence from the State Drug Licensing Authority. Together they make up a complete IVD import license India importers can trade under.

IVD import registration at a glance

In Vitro Diagnostic Regulation India: How IVDs Are Regulated

In vitro diagnostic regulation India has moved in stages. Before 2018, only a few critical diagnostic kits, such as those for HIV, hepatitis B, hepatitis C and blood grouping, were regulated as drugs. The Medical Devices Rules, 2017, in force from 1 January 2018, brought IVDs into a dedicated framework with their own risk classes, and licensing was then extended in phases until every class of IVD needed a licence from 1 October 2023. Today, all IVD medical devices CDSCO regulates need a licence to be imported, manufactured or sold, except where a specific exemption applies.

The main rules that apply to IVD imports are:

• Classification into Class A, B, C or D by the risk of a wrong result to the patient and to public health
• An MD-15 import licence for each IVD and overseas site, held by an Indian authorised agent
• Performance evaluation evidence in place of the clinical investigation used for other devices, with laboratory evaluation for some high-risk kits
• Labelling with the importer's details and licence number, storage conditions and expiry
• Post-market duties, including complaint handling, adverse event reporting and recalls
• A sale licence or MD-42 registration for every warehouse that stores and sells the IVDs

Who Needs an IVD Import License in India?

You need an IVD import license India requires if you bring in, for sale or distribution:

• Rapid diagnostic test kits for infections, pregnancy, drugs of abuse or cardiac markers
• ELISA, CLIA and other immunoassay kits for hospital and reference laboratories
• Clinical chemistry and haematology reagents, calibrators and controls
• Molecular diagnostic kits, such as PCR assays, and the reagents that go with them
• IVD analysers and instruments, along with their dedicated reagents and software
• Blood grouping reagents and blood bank screening kits
• Specimen collection devices that are classified as IVDs

Foreign manufacturer IVD registration India: the authorised agent

Foreign manufacturer IVD registration India works through an Indian authorised agent. The overseas manufacturer appoints an Indian company by an authenticated power of attorney; the agent files the MD-14, holds the MD-15 and is responsible to CDSCO for the imported IVDs. The agent must hold a wholesale drug licence or a sale registration for devices, or a manufacturing licence, and must be able to handle complaints, vigilance and recalls in India. Manufacturers that want flexibility often appoint a regulatory agent rather than tying the licence to a single distributor.

Choosing the Right Route for Your IVD

Not every IVD import goes straight to an MD-14. Choose the route by what you want to do with the product:

Most importers need two of these: the MD-15 for the product and a state licence for the warehouse. High-risk kits often need three, adding a test licence for evaluation samples. Mapping the route for each product at the start avoids filing an MD-14 that CDSCO cannot grant yet.

If you are not sure which route applies, start with the intended use written in one sentence: what the test detects, in which sample, for whom and by whom it is performed. That sentence decides the class, the predicate question and the route, and it should match the wording later used in the Device Master File, the labels and your marketing. Regovex drafts it with you before anything else is prepared.

IVD Classification CDSCO: IVD Class A, B, C and D in India

IVD classification CDSCO applies is set out in the First Schedule of the Medical Devices Rules, 2017. Unlike other devices, IVDs are not classed by contact with the body, because they never touch the patient. They are classed by the risk that a wrong result poses to the individual patient and to public health. The IVD class A B C D India system therefore puts blood-screening tests at the top and general laboratory products at the bottom.

These examples follow the general principles in the rules and CDSCO's published risk classification lists for IVDs. The exact class of your kit depends on its intended use: the same analyte can be Class B for professional monitoring and Class C for self-testing, or Class C for diagnosis and Class D when used to screen donated blood. CDSCO's IVD classification lists should be checked first, and where a kit is not listed, the classification rules are applied to its intended use.

Why the class matters for an IVD import

The class decides almost everything about your application:

• The fee: Class A and B IVDs cost USD 1,000 per site and USD 10 per IVD; Class C and D IVDs cost USD 3,000 per site and USD 500 per IVD
• The evidence: higher classes need fuller performance data and, for some kits, laboratory evaluation in India
• The review: Class C and D files are reviewed more closely and often draw more queries
• Grouping: IVDs can be grouped into one application only when they share the class, manufacturer, technology and intended use

Getting the class right before writing the Device Master File is the single most effective way to avoid delays. Regovex gives every client a written classification note for each IVD.

Grouping IVDs to save time and fees

CDSCO's grouping guidance allows related IVDs to be filed together when they come from the same manufacturer and share the class, technology and intended use. Common groups are a test kit with its matched calibrators and controls, a family of reagents run on one analyser, or the same assay in different pack sizes. Correct grouping reduces the number of Device Master Files and keeps the per-IVD fees predictable. Wrong grouping, such as combining a self-test with a professional test, or kits from two manufacturers, leads to queries and to being asked to split the file. Regovex plans the grouping before the Device Master File is written, so the file and the grouping match.

IVD Performance Evaluation India

IVD performance evaluation India requires replaces the clinical investigation used for other devices. Instead of trials on patients, the manufacturer shows that the kit detects what it claims to detect, accurately and consistently, using samples.

What performance data includes

• Analytical performance: sensitivity, specificity, limit of detection, precision (repeatability and reproducibility), interference and cross-reactivity, and the measuring range for quantitative tests
• Clinical performance: diagnostic sensitivity and specificity against a reference method, using an adequate number of positive and negative samples
• Stability: shelf-life and in-use stability under the labelled storage conditions
• Population relevance: evidence that the kit performs on samples representative of the Indian population, where relevant

Laboratory evaluation in India for high-risk kits

For certain high-risk IVDs, such as kits used to detect HIV, hepatitis B and hepatitis C, CDSCO requires the kit to be evaluated by a CDSCO-designated laboratory, such as the National Institute of Biologicals, before approval. This evaluation is often the longest step in the process, because samples have to be imported, tested and reported. Importers bring in the evaluation samples under an MD-17 test licence, applied for on MD-16.

New IVDs with no predicate

An IVD that has no predicate in India, for example a test for a new analyte or a new technology, may need a clinical performance evaluation in India before it can be licensed for import, under the rules for new IVDs. This takes longer and needs its own permission, so check whether your kit has a predicate before planning a launch date.

IVD Import Documents Required

The IVD import documents required with Form MD-14 fall into four groups.

IVD Device Master File CDSCO expects

The IVD Device Master File CDSCO reviews follows the format in the Medical Devices Rules for IVDs. For each IVD or group, it usually covers:

• Executive summary, intended use, intended user (professional or self-testing) and the specimen type
• Description of the kit, its components, principle of the test and the instruments it runs on
• Classification with the rule applied
• Design and manufacturing information, including critical raw materials such as antigens and antibodies
• Essential principles checklist and the standards applied
• Risk management file
• Analytical and clinical performance evaluation data
• Stability data supporting the shelf life and storage conditions
• Labels, instructions for use and the India-specific label
• Post-market surveillance data and vigilance history from other markets

Plant Master File

One Plant Master File describes the overseas manufacturing site: its organisation, premises, equipment, quality management system, production and quality control, and the products it makes. One PMF can support several IVDs made at the same site.

Certificates and legal documents

• ISO 13485 certificate for the overseas site
• Free sale certificate, or approvals in the reference markets where the IVD is sold
• Power of attorney appointing the Indian authorised agent, authenticated by apostille or embassy attestation
• The agent's wholesale licence, MD-42 registration or manufacturing licence
• Undertakings and declarations required by Form MD-14

Common gaps in IVD files

• Performance data based on too few positive samples, or on samples from a different population
• Stability data that does not support the labelled shelf life or storage temperature
• A kit grouped with controls or calibrators from a different manufacturer
• Labels missing the storage conditions, the importer's details or the licence number
• A power of attorney that does not list every IVD and site

MD 14 IVD Import License: Step-by-Step Process

The MD 14 IVD import license process runs in this order:

1. Classify each IVD and decide the grouping.
2. Appoint the Indian authorised agent and execute the power of attorney.
3. Check whether laboratory evaluation is needed and, if so, import samples under an MD-17 test licence.
4. Prepare the Device Master File and Plant Master File with the manufacturer.
5. Register on ONDLS or your state drug licensing portal and file Form MD-14 with the documents and fee.
6. Answer CDSCO's queries and complete any laboratory evaluation.
7. Receive the MD-15 import licence listing each approved IVD and site.
8. Arrange the warehouse licence and cold chain, then plan the first consignment.

IVD Import Fees CDSCO

The IVD import fees CDSCO charges are set in the Second Schedule of the Medical Devices Rules and paid in US dollars:

Worked example

An importer bringing in 20 Class B clinical chemistry reagents and 4 Class C infectious disease kits from one overseas site pays USD 1,000 + 20 × USD 10 = USD 1,200 for the Class B group, and USD 3,000 + 4 × USD 500 = USD 5,000 for the Class C group, if the two groups are filed separately. Laboratory evaluation charges, where required, are paid separately to the laboratory. Confirm current amounts on the portal before paying; Regovex gives a written estimate first.

Timelines for IVD Import Registration

The licence is valid in perpetuity once granted, provided the retention fee is paid before the end of every five-year period. Adding new IVDs or sites later needs an endorsement with its own fee.

Planning your first year as an IVD importer

A realistic first-year plan for a new IVD importer starts with a small, well-chosen portfolio: a few kits with strong performance data and a clear predicate, rather than a long list that stretches the manufacturer's documentation. File those first, set up the warehouse licence and cold chain while CDSCO reviews them, and add further kits by endorsement once the first MD-15 is granted. Budget for the government fees, the laboratory evaluation where needed, temperature-controlled freight and the professional fees, and keep a reserve for queries that ask for more data. Importers who plan this way usually reach the market sooner than those who file everything at once.

Diagnostic Kit Import License India: Kits, Reagents and Analysers

A diagnostic kit import license India requires is the same MD-15, but the way you plan the file depends on what you import.

IVD kit import India: rapid tests and immunoassays

For IVD kit import India, each kit with a distinct intended use is a separate IVD for fee and review purposes, even when several kits share a platform. Kits with matched controls and calibrators from the same manufacturer can often be grouped with them. Check the class of each kit first: an infectious disease kit can be Class C for diagnosis and Class D for blood screening, which changes the fee and the evidence.

Rapid test kit import license India

A rapid test kit import license India importers need is the MD-15 for each rapid test, with its own class and performance data. Rapid tests for infections such as HIV, hepatitis, malaria, dengue or syphilis are often higher class and may need laboratory evaluation before approval. Rapid tests sold for self-testing at home are treated more strictly than the same tests used by professionals, because the user interprets the result. Plan the labels in English and, where intended for home use, with clear instructions the lay user can follow.

Import of IVD reagents India license

The import of IVD reagents India license covers reagents, calibrators and controls sold for diagnostic use. Reagents meant only for a specific closed analyser are usually filed together with that system, while open-system reagents are filed on their own. General laboratory reagents with no specific diagnostic claim are usually Class A. Research-use-only reagents that are not sold for diagnosis are outside IVD licensing, but they must be labelled for research use only and must not be marketed for diagnosis.

Analysers and instruments

IVD analysers, readers and their software are IVDs too. The analyser is usually filed with its dedicated reagents and calibrators, and the Device Master File must cover the instrument's design, software validation and electrical safety as well as the assays.

Laboratories, hospitals and point-of-care brands

Different buyers bring different requirements. Reference laboratories and hospital chains usually buy closed-system analysers with their reagents, so the MD-15 must list both the instrument and every reagent used on it. Blood banks need blood-grouping and screening reagents that are Class D and closely reviewed. Point-of-care and home-testing brands sell rapid tests and meters, often through pharmacies and online, where the label and instructions must suit a lay user. Ask your key customers early which documents they will need from you, such as the MD-15, the certificate of analysis for each lot and the cold-chain records, so you can provide them from the first order.

Self-tests and home-use IVDs

Self-tests, such as home pregnancy tests, blood glucose meters and some infectious disease tests, get special attention under in vitro diagnostic regulation India applies. Because a lay person collects the sample, performs the test and reads the result, the IVD classification CDSCO gives a self-test is often higher than for the same test used by a professional, and the file must show that ordinary users can get a correct result. Expect CDSCO to look closely at usability data, the clarity of the instructions and the warnings about what to do after a positive or negative result. If you plan to sell the same kit to laboratories and to consumers, treat them as two products with two intended uses, and plan the diagnostic kit import license India filing for each accordingly. Labels and instructions for self-tests should be written in plain English, and many importers add a regional-language leaflet to reduce user error.

Cold Chain and Storage for Imported IVDs

Many IVD kits and reagents must be stored at 2 to 8 °C, and some frozen. CDSCO and the port officer check that the labelled storage conditions are met, and a kit stored outside them can lose its performance. Plan the cold chain from the manufacturer's dock to your customer: temperature-controlled freight, prompt customs clearance, data loggers in each shipment, a validated cold room or refrigerators at the warehouse, and temperature records that the State Licensing Authority can inspect. The warehouse licence from the State Drug Licensing Authority will look at these arrangements.

Labelling imported IVDs for India

Every imported IVD must carry the particulars the Medical Devices Rules require, including the name of the IVD and its intended use, the manufacturer's name and address, the importer's name and address, the import licence number, the lot number, the date of manufacture and expiry date, storage conditions, and any warnings. Instructions for use must describe the test procedure, interpretation of results and performance characteristics. Many importers add an India sticker with the importer details and licence number before release; make sure the sticker does not cover the manufacturer's storage symbols or expiry. For self-tests, the instructions must be clear enough for a lay user to perform and read the test correctly.

Port clearance for IVD consignments

Registered IVDs are cleared at ports with a CDSCO port office. The officer checks the consignment against the MD-15, the labels, the lot numbers and the expiry dates, and can draw samples. Because many IVDs are temperature-sensitive, any hold at the port is a risk to the product: keep the MD-15, invoices, packing lists, certificates of analysis and temperature data ready before the shipment lands, and use a customs broker who handles cold-chain cargo. A kit or pack size that is not on the licence is the most common reason for a consignment to be held.

Importing IVDs from China, Korea, Europe and the USA

The MD-14 route is the same whatever the country of origin, but the documents behave differently. Manufacturers in the European Union usually support their files with CE marking under the EU IVD Regulation and notified body certificates; manufacturers in the USA with FDA clearance or approval; manufacturers in Korea, Japan and Australia with approvals from their own regulators. Chinese manufacturers, who supply a large share of rapid tests and reagents imported into India, usually provide NMPA registration certificates and export documents, and since China joined the Hague Apostille Convention in November 2023, their power of attorney and certificates can be apostilled. Whatever the source, CDSCO looks for the same things: a clear intended use, strong performance data, a certified quality system and documents that match each other exactly. Approvals in reference markets support the file but do not replace the Indian review.

After the MD-15: Staying Compliant

• Import only what is licensed: every IVD, pack size and site must be on the MD-15 or an endorsement
• Label correctly with the importer's name and address, the licence number, storage conditions, expiry and lot number
• Keep import and sale records by lot, so any kit can be traced and recalled
• Report adverse events and complaints, such as false results, as the rules require
• Pay the retention fee before each five-year period ends
• Apply for endorsements before importing new IVDs, new sites or changed products
• Keep the warehouse licence current, with cold-chain records

Common Mistakes in IVD Import Registration

• Classifying a kit by its technology instead of its intended use
• Filing a self-test as if it were for professional use
• Weak performance data, or data that does not cover the claimed sample types
• Forgetting that high-risk kits may need laboratory evaluation in India
• Grouping unrelated kits or kits from different manufacturers in one file
• Shipping before the MD-15 is granted, or importing new kits before endorsement
• No cold-chain plan for temperature-sensitive reagents

Checklist Before You File the MD-14 for IVDs

• Class confirmed for each IVD against CDSCO's IVD lists and its intended use
• Grouping planned, with self-tests and professional tests kept apart
• Need for laboratory evaluation checked, and MD-17 test licence planned if required
• Predicate in India confirmed, or new-IVD permission planned
• Indian authorised agent appointed with an authenticated power of attorney
• Device Master File complete with analytical and clinical performance and stability data
• Plant Master File, ISO 13485 certificate and free sale certificate current
• Labels and instructions for use prepared with India-specific details
• Warehouse licence and cold chain arranged
• Fees calculated per site and per IVD

Working through this list keeps your IVD import registration well inside the nine-month review period.

How Regovex Handles Your IVD Import Registration in India

1. Free classification check for every kit, reagent and analyser, with a written note on class and grouping.
2. Route plan: whether laboratory evaluation, a test licence or a new-IVD permission is needed before the MD-14.
3. Authorised agent set-up and power of attorney, with the authentication route for the manufacturer's country.
4. Device Master File and Plant Master File review with your manufacturer, focused on performance and stability data.
5. MD-14 filing on ONDLS or your state drug licensing portal and fee payment.
6. Query replies within 24–48 hours and coordination of any laboratory evaluation.
7. Warehouse licence, cold-chain records and label checks before the first consignment.

Why Importers Choose Regovex as Their IVD Regulatory Consultant India

• IVD-specific experience. As an IVD regulatory consultant India importers rely on, we read performance data, not just paperwork.
• All device routes together: MD-14, MD-15, MD-16, MD-17, MD-42 and manufacturing licences, as a CDSCO registration consultant and drug regulatory consultant in India.
• Manufacturer coordination across time zones, with clear document lists.
• Clear pricing, with government and professional fees shown separately in writing.
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback.
• One point of contact from the first call to retention fees and endorsements.

IVD Import Registration Services in India and Nearby Areas

Regovex files IVD import registrations for diagnostic distributors, laboratory suppliers, hospital suppliers and overseas IVD manufacturers in India. Documents are collected digitally, and applications are filed on ONDLS or your state drug licensing portal. Our office is in Aligarh, and we work with clients across Delhi NCR, Uttar Pradesh and the rest of India.

We also serve importers in .

Related services:

• Medical Device Import License (MD-14 / MD-15)
• CDSCO Registration in India
• Medical Device Test License
• MD-42 Wholesale Registration
• Class A Medical Device Registration

What Our Clients Say

I had great experience working with Regovex Consulting on the regulatory side of my product. Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations. — Parichit Dhawan, Director, Feorah Wellness & Cosmetics

Medical device import clients include Access 2 Healthcare.