How to Register IVD Products with CDSCO in India | Complete 2026 Guide

Planning to sell diagnostic kits in India? Then you need to know how to register IVD products with CDSCO in India before you ship a single box. In short, you classify your device, appoint an Indian authorised agent, build a technical file, file Form MD-14, and receive an import licence in Form MD-15.

That sounds simple, yet many foreign manufacturers lose months to wrong classification, missing notarised papers, or weak evaluation data. All IVD medical devices in India fall under the Medical Devices Rules, 2017, and the Central Drugs Standard Control Organisation (CDSCO) reviews every import application.

This guide walks you through each stage in plain English. You will see the forms, documents, fees, timelines, and mistakes to avoid. By the end, you will know what to prepare and when to ask for expert help.

Quick Answer: How to Register IVD Products with CDSCO in India in 8 Steps

Here is the short version for readers who want the roadmap first.

1. Confirm your product is an IVD and find its risk class (A, B, C or D) in the CDSCO list.
2. Appoint an Indian authorised agent who holds a valid wholesale licence.
3. Check whether your kit needs a performance evaluation in India.
4. Compile the device master file, plant master file, ISO 13485 certificate, and labels.
5. Create an account on the CDSCO online portal and submit Form MD-14.
6. Pay the site fee and the product fee.
7. Answer CDSCO queries within the deadline.
8. Receive the import licence in Form MD-15, then keep it alive with retention fees.

Rules and fees change, so confirm the latest details on the CDSCO In-Vitro Diagnostics page before you file.

What Is an IVD, and Why Does CDSCO Regulate It?

An in vitro diagnostic (IVD) device tests samples such as blood, urine, or tissue outside the human body. Glucose strips, pregnancy tests, HIV screening kits, and laboratory analyzers all count.

CDSCO states that IVD kits and reagents are regulated under the Medical Devices Rules, 2017. Its In-Vitro Diagnostics Division in New Delhi reviews them, according to the CDSCO IVD FAQ document. Analyzers, instruments, and qualifying software also fall inside the rules, and CDSCO publishes their classification.

The scope is wide. Before 2017, only a small group of notified kits needed full registration. Today, far more products need a licence, so a kit that sold freely in the past may now need approval.

Some products are banned outright. For example, CDSCO lists serodiagnostic kits for tuberculosis as prohibited for import, manufacture, and sale. Check the prohibited list before you invest in a dossier.

Who Needs to Register IVD Products with CDSCO?

Your route depends on what you plan to do in India. CDSCO's own IVD page sets out the main pathways:

• Import of any IVD class: apply in Form MD-14 and receive an import licence (MD-15).
• Manufacture of Class C or D IVDs in India: apply in Form MD-7 or MD-8 and receive Form MD-9 or MD-10 from the Central Licensing Authority.
• Manufacture of Class A or B IVDs in India: apply in Form MD-3 and receive Form MD-5 (the state authority handles most of these).
• Import for testing or evaluation: apply in Form MD-16 and receive a test licence in Form MD-17.
• Brand-new IVDs with no equivalent in India: apply for clinical performance evaluation in Form MD-24 first.

This guide focuses on the import route, because most overseas brands use it. If you plan to manufacture locally, read our guide on CDSCO manufacturing licences.

Step 1: Classify Your Device Before You Register IVD Products with CDSCO

Classification drives everything: the form, the fee, the review depth, and the timeline. Get it wrong, and the whole file stalls.

India uses four risk classes. Class A is low risk. Class B is low to moderate. Class C is moderate to high. Class D is high risk, such as blood-screening tests for serious infections.

CDSCO publishes IVD classification lists for reagents, kits, analyzers, instruments, and software. Search your product name there first. The lists were last consolidated in an October 2023 update.

What if your product is missing? In early 2026, CDSCO added a risk classification module for IVDs to its online system. You can now request an official ruling instead of guessing.

Borderline products need extra care. For example, a software tool that interprets lab results may or may not count as an IVD. Our article on borderline product classification explains how to separate qualification from risk class.

Step 2: Appoint an Indian Authorised Agent

A foreign manufacturer cannot file an import application alone. You need an Indian company that holds a valid wholesale licence (Form MD-42, or the older Form 20B/21B) to act as your Indian authorised agent.

The agent files the application, talks to CDSCO, and handles queries. You give the agent a Power of Attorney, usually notarised and legalised in your home country.

Choose this partner with care. Ask these questions:

• Does the agent have regulatory staff who know IVD files?
• Does the agent reply to CDSCO queries within days?
• What happens to the licence if you change agents later?

Put the answers in a written agreement. A weak agent can slow your launch more than any technical gap.

Step 3: Prepare the Documents to Register IVD Products with CDSCO

Documents decide the speed of approval. CDSCO publishes a detailed checklist for MD-14, and you should follow it line by line. In practice, you need these core items:

• Covering letter and signed application details
• Power of Attorney for the Indian agent
• The agent's wholesale licence
• Valid ISO 13485 certificate for the manufacturing site
• Free Sale Certificate or approvals from your home market
• Device master file (IVD master file under the Fourth Schedule)
• Plant master file (site master file)
• Product specifications, stability data, and verification reports
• Labels and instructions for use that meet Indian labelling rules
• Performance evaluation data, where required
• Proof of approvals in other countries, such as CE or FDA

Keep every name and address identical across documents. A small mismatch between the legal manufacturer and the site name triggers a query.

Strong technical files also save time later. Our team supports this work through technical documentation consulting, and you can review related quality needs under ISO 13485 support.

Step 4: Plan the Performance Evaluation

Performance evaluation proves that your kit works in the Indian setting. Not every IVD needs it, but critical kits often do.

CDSCO's 2026 draft import guidance says high-risk kits, such as those for HIV, cancer, or malaria, need a Performance Evaluation Report from a CDSCO-registered laboratory. You can read the draft guidance for IVD imports on the CDSCO site.

CDSCO keeps a list of laboratories approved for this work. Pick a lab early, because sample shipment and testing take time.

How do you get kits into India for the study? Use the test licence route. Form MD-16 lets you import limited quantities for testing, evaluation, or training. Approval is much faster than the commercial licence.

Some consultants report that devices approved in reference markets, such as the USA, EU, Canada, Japan, or Australia, may avoid certain clinical study requirements. However, treat this as a point to confirm with CDSCO, not a guarantee.

Step 5: File Form MD-14 on the CDSCO Online Portal

Now you are ready to submit. The MD-14 application goes through CDSCO's online medical device portal, which many professionals still call the SUGAM portal. The portal accepts MD-14, while the 2026 draft guidance links MD-16 filings to the National Single Window System.

Follow this flow:

1. Register an account for your Indian agent with a valid mobile number and email.
2. Select the IVD import application and choose the device class.
3. Enter manufacturer, site, and product details.
4. Upload the documents in the order the checklist shows.
5. Pay the fees online.
6. Submit and save the application number.

Check every upload before you click submit. CDSCO's guidance highlights that technical errors are a leading cause of delay, so a second reviewer is worth the effort.

After submission, CDSCO may raise queries. Reply within the stated deadline, and answer each point with a document reference. Short, precise replies move files forward.

How Long Does It Take to Register IVD Products with CDSCO in India?

Timelines vary by class and by file quality. The CDSCO IVD FAQ addendum lists a 90-day timeline for Form MD-14. However, real-world projects often run longer once queries and evaluation steps enter the picture. Industry sources commonly quote six to nine months for import licences, and the 2026 draft guidance cites up to 270 days.

Fees follow the Second Schedule of the Medical Devices Rules. Commonly published figures look like this:

Class A IVDs that are non-sterile and non-measuring follow a simple online registration route instead of a full import licence.

CDSCO's 2026 FAQ addendum also discusses updated site fee figures, so check the current CDSCO addendum before budgeting. Remember to add agent fees, notarisation, laboratory costs, and testing samples.

Manufacturing in India and Registering New IVDs

Some readers do not import. They plan to make IVDs in India, or they have a new type of kit.

For local manufacturing, Class C and D products need a licence from the Central Licensing Authority after a site inspection. Class A and B products follow the state licensing route. In both cases, you must show a working quality system.

A "new IVD" has no comparable device on the Indian market. It needs permission first: Form MD-24 for clinical performance evaluation, then Form MD-28 for import or manufacture, with permission in Form MD-29. Only after that can you apply for the normal commercial licence.

Rule 63 also matters here. Recent changes may help devices already approved in the EU, as our summary of India's 2026 Rule 63 amendment explains. Always confirm how the amendment applies to your own IVD.

After You Get MD-15: Staying Compliant

Getting the licence is not the finish line. You must keep it healthy.

• Pay retention fees on time. CDSCO's addendum describes late-fee windows of 90 and 180 days, so missing the date is costly.
• Report changes. New sites, name changes, or new products need endorsements or fresh applications.
• Report adverse events. CDSCO has an adverse event reporting form for medical devices, and it has invited comments on an IVD-specific version.
• Control labels. Every pack sold in India must carry the required Indian labelling details.

Build a small compliance calendar. Assign one person at your agent and one person on your team to own it.

Five Mistakes to Avoid When You Register IVD Products with CDSCO

Most delays come from the same few errors. Avoid these:

1. Guessing the class. Always confirm it in the CDSCO list or through a ruling request.
2. Using an unprepared agent. Check their IVD experience first.
3. Submitting inconsistent documents. Names, addresses, and dates must match everywhere.
4. Ignoring performance evaluation. Plan the lab early for critical kits.
5. Missing query deadlines. A late reply can stop the file.

Also, do not treat India as a copy of the EU file. Your CE-marked IVDR dossier helps, but India has its own forms and checklists. If you already work on EU files, our article on Class D IVD verification under IVDR shows how evidence can be reused, and our global MedTech strategy guide explains how to sequence markets.

Should You Hire a Consultant to Register IVD Products with CDSCO?

You can file the application yourself through your agent. However, many manufacturers choose expert help when the product is Class C or D, the file is large, or the launch date is tight.

A good consultant checks classification, reviews the dossier, coordinates the laboratory, and answers CDSCO queries. That support reduces rework.

NKB Regovanta has supported regulatory projects since 2018 and lists more than 350 completed projects on its website. You can explore the India CDSCO registration service, the dedicated IVD industry page, or the broader global medical device and IVD registration service.

For a wider view of the process, read our guides on medical device registration in India and how to register a medical device in India. Ready to start? Book a consultation.

What Regulatory Professionals Discuss on Reddit

Practitioners often swap practical notes about CDSCO filings in online communities. The r/regulatoryaffairs community covers filing and career questions across many markets. The r/MedicalDevices community also hosts posts and comments about global approvals.

Search those communities for terms like CDSCO, MD-14, or Indian authorised agent. You will find real stories about delays and agent choices.

Use these threads for ideas only. Reddit comments are opinions, not legal advice, so verify every point against official CDSCO documents.

Frequently Asked Questions

How do I register IVD products with CDSCO in India?

Classify your IVD, appoint an Indian authorised agent, prepare the device master file and supporting documents, and submit Form MD-14 on the CDSCO online portal. After review and replies to queries, CDSCO issues the import licence in Form MD-15.

Is CDSCO registration mandatory for IVD products in India?

Yes, in most cases. CDSCO states that import of all IVD classes needs a licence under the Medical Devices Rules, 2017. Only Class A non-sterile, non-measuring devices follow a simpler online registration route.

Which form do I need to import IVD devices into India?

Use Form MD-14 to apply and receive the import licence in Form MD-15. For testing, evaluation, or training samples, use Form MD-16, which leads to a test licence in Form MD-17.

How long does CDSCO IVD registration take?

The published timeline for MD-14 is 90 days, but real projects often take six to nine months or more. Query rounds, laboratory evaluation, and document quality all affect the final date.

How much does it cost to register an IVD with CDSCO?

Commonly published fees are US$1,000 per site plus US$10 per product for Class A and B, and US$3,000 per site plus US$500 per product for Class C and D. Check the latest CDSCO fee schedule before you pay.

Can a foreign manufacturer apply to CDSCO directly?

No. A foreign manufacturer works through an Indian authorised agent that holds a valid wholesale licence. The agent files the application and handles communication with CDSCO.

Do I need performance evaluation data for my IVD?

Often yes for high-risk kits. CDSCO guidance mentions a Performance Evaluation Report from a registered laboratory for critical kits, such as those for HIV, cancer, or malaria. Confirm your product's exact requirement before you file.

What if my IVD is not in the CDSCO classification list?

Submit a risk classification request through the CDSCO online system, which added an IVD module in early 2026. CDSCO then confirms the class so that you can pick the right route.

How long does an MD-15 import licence stay valid?

Under current rules, the licence stays in force as long as you pay the retention fee on time at the required interval. Check the latest CDSCO circular on retention, because older sources describe a fixed five-year term.

Final Thoughts: How to Register IVD Products with CDSCO in India

Now you know how to register IVD products with CDSCO in India: classify the device, choose a capable agent, build a clean dossier, plan performance evaluation, file Form MD-14, and manage the licence after approval.

Start with classification and documents today. Those two steps remove most delays. If you want a second pair of eyes, speak with the NKB Regovanta team and get a clear plan for your IVD range.