How to Register a Medical Device with CDSCO in India | The 2026 Step-by-Step Guide
how to register a medical device with CDSCO in India
Table of Contents
23 sections in this regulatory guidance
Do you plan to sell a medical device in the Indian market? Then you need to know how to register a medical device with CDSCO in India before your first shipment or production batch. The Central Drugs Standard Control Organisation (CDSCO) controls every device that enters Indian hospitals, clinics, and pharmacies. Without the right approval, your product cannot legally reach buyers.
The opportunity is large. According to IBEF's medical devices industry report, India's device market could reach about US$ 50 billion by 2030, and imports still supply most of it. However, many companies lose months to wrong forms, missing files, and avoidable queries.
This guide fixes that. You will learn how CDSCO medical device registration works, which licence route fits your product, what documents you need, what it costs, and what changed in 2026.
How to Register a Medical Device with CDSCO in India: Quick Answer
Here is the short version of the process. Each step gets a full section below.
Confirm your product is a notified medical device and classify it as Class A, B, C, or D.
Choose your route: manufacturing licence, loan licence, import licence, or simple Class A registration.
Appoint an Indian authorised agent if you are a foreign manufacturer.
Prepare the Device Master File, Plant Master File, ISO 13485 certificate, and labels.
Create an account on the CDSCO MD Online portal and file the correct form with fees.
Answer queries and complete the audit or inspection that your class requires.
Receive your licence and pay the retention fee every five years to keep it active.
What Does It Mean to Register a Medical Device with CDSCO?
Registering a device with CDSCO means getting written permission from the regulator to make, import, sell, or distribute it in India. The legal base is the Medical Devices Rules 2017, which sit under the Drugs and Cosmetics Act, 1940.
The word "registration" often confuses people. In daily use, it covers several approvals. For example, a manufacturer gets a manufacturing licence on Form MD-5 or MD-9. An importer gets an import licence Form MD-15. A low-risk Class A non-sterile, non-measuring device only needs an online registration number.
So, when someone asks how to register a medical device with CDSCO in India, the honest answer starts with a question: who are you, and what is your device? A foreign brand, an Indian factory, and a distributor each follow a different path.
If you want a deeper look at how CDSCO defines the applicant, product, and route, read our guide on CDSCO medical device registration guidelines in India.
Why CDSCO Medical Device Registration Matters in 2026
CDSCO now regulates all medical devices, not just a short notified list. The phased licensing regime covered Class A and B devices from October 2022 and Class C and D devices from October 2023. As a result, every device on the Indian market must carry valid approval.
Selling without a medical device licence in India carries real risk. CDSCO and state regulators can seize stock, cancel licences, and start prosecution. Hospitals and government tenders also ask for licence copies before they place orders.
The table below shows the practical difference.
Table 1: Registered vs unregistered medical devices in India
| Factor | With CDSCO Approval | Without CDSCO Approval |
|---|---|---|
Legal sale | Allowed across India | Illegal; stock can be seized |
Hospital and tender access | Eligible to bid and supply | Rejected at vendor screening |
Customs clearance | Smooth with MD-15 or registration number | Consignment held at port |
Distributor trust | Easier to sign partners | Partners avoid legal exposure |
Brand reputation | Signals safety and quality | Risk of public enforcement action |
Three types of businesses usually need approval. Each one uses a different form and licensing authority.
Indian Manufacturers
If you make devices in India, you need a manufacturing licence. The State Licensing Authority handles Class A and B devices. The Central Licensing Authority, led by the Drugs Controller General of India (DCGI), handles Class C and D devices.
Foreign Manufacturers and Importers
A foreign company cannot apply directly. Instead, it appoints an Indian authorised agent. This agent must hold a valid manufacturing licence or a wholesale licence. The agent files the import application and takes legal responsibility for the product in India.
Distributors and Sellers
People who stock, sell, or distribute devices also need a registration certificate from their state. Our team explains this in the MD-42 medical device registration certificate service page.
Step 1: Classify Your Device Under the Medical Devices Rules 2017
Device risk classification is the first real decision in how to register a medical device with CDSCO in India. It decides everything that follows. It sets your form, fee, authority, audit type, and timeline. The Medical Devices Rules 2017 use four classes based on risk to the patient.
CDSCO publishes classification lists for many device categories. Always check these lists first. If your product is not listed, apply the rules in the First Schedule, which look at invasiveness, duration of use, and whether the device is active.
Table 2: CDSCO medical device risk classes with examples
| Class | Risk Level | Common Examples | Licensing Authority (Manufacture) |
|---|---|---|---|
Class A | Low | Surgical dressings, alcohol swabs, tongue depressors | State Licensing Authority |
Class B | Low to moderate | Hypodermic needles, suction equipment, thermometers | State Licensing Authority |
Class C | Moderate to high | Ventilators, bone fixation plates, infusion pumps | Central Licensing Authority |
Class D | High | Heart valves, implantable pacemakers, stents | Central Licensing Authority |
Some products sit on the line between a device, a drug, or a general product. In those cases, settle qualification first and class second. Our article on borderline medical device classification strategy walks through that decision.
Step 2: Choose the Right Licence Route to Register a Medical Device with CDSCO in India
Once you know the class, you can pick the right form. Using the wrong form is one of the most common reasons for rejection. The table below maps each route.
Table 3: CDSCO application forms and licences by route
| Route | Application Form | Licence Issued | Who Decides |
|---|---|---|---|
Manufacture, Class A and B | MD-3 | MD-5 | State Licensing Authority |
Loan licence, Class A and B | MD-4 | MD-6 | State Licensing Authority |
Manufacture, Class C and D | MD-7 | MD-9 | Central Licensing Authority |
Loan licence, Class C and D | MD-8 | MD-10 | Central Licensing Authority |
Import, all classes | MD-14 | MD-15 | Central Licensing Authority |
Test licence for manufacture | MD-12 | MD-13 | Central Licensing Authority |
Class A non-sterile, non-measuring | Online registration | Registration number | CDSCO portal |
For manufacturing, a manufacturing licence Form MD-5 covers lower-risk devices. Our Class A and B manufacturing forms MD-3 and MD-5 page covers that route. Higher-risk devices use the Class C and D manufacturing forms MD-7 and MD-9.
For imports, see our import licence for medical devices (Forms MD-14 and MD-15) service. If your device has no predicate in India, a separate permission route applies, and clinical data may be needed.
Step 3: Prepare Documents to Register a Medical Device with CDSCO in India
Strong documents shorten review time. Weak documents invite long query cycles. CDSCO expects a clear, traceable file for every device.
Device Master File
The Device Master File (DMF) describes your product in detail. It covers design, materials, manufacturing steps, performance tests, biocompatibility, sterilisation, and risk management. Appendix II of the Fourth Schedule sets its format. For biocompatibility planning, see our guide on ISO 10993 biological evaluation.
Plant Master File
The Plant Master File (PMF) describes your factory. It lists premises, equipment, staff, quality control, and environmental controls.
Quality System Proof
CDSCO expects a quality system that meets the Fifth Schedule, which follows ISO 13485. An ISO 13485 certification from an accredited body strengthens your file. The ISO 13485 standard sets these quality management rules, and ISO 14971 guides your risk file. Learn how to build usable records in our post on ISO 13485 documentation.
Import-Specific Papers
Importers also need a Free Sale Certificate from the country of origin, a power of attorney for the Indian agent, and the agent's licence. Our Free Sale Certificate (FSC) page explains the requirements.
Step 4: How to Register a Medical Device with CDSCO in India Online
CDSCO runs all device applications through the CDSCO MD Online portal. Paper filing is no longer the norm. Here is how the online process works.
Create and Verify Your Account
First, register the company on the portal. Upload proof of identity, address proof, and the authorised signatory's details. CDSCO or the state authority verifies the account before you can file.
Fill the Right Form
Next, select the correct form from Step 2. Enter device details, such as generic name, brand name, model numbers, intended use, class, and manufacturing site. Group devices carefully, since fees apply per site and per distinct device.
Upload Documents and Pay Fees
Then, upload the DMF, PMF, certificates, labels, and instructions for use. Pay the government fee through the Bharatkosh payment link inside the portal. Keep the challan, because the portal ties the payment to your application.
Track the Status
Finally, track progress on your dashboard. Queries appear there, and you reply through the same system. Assign one owner to check it daily.
Our guide on how to register a medical device in India adds more screen-level tips for first-time filers.
Step 5: Audits, Inspections, and CDSCO Queries
After filing, CDSCO checks both the paperwork and the site. This stage tests how well you prepared, and it is where learning how to register a medical device with CDSCO in India pays off. The type of check depends on the class.
For Class A manufacturing, the state authority can grant the licence first. A notified body audit then follows to confirm the site meets the rules. For Class B, a notified body registered with CDSCO audits the site before the licence decision.
For Class C and D, the Central Licensing Authority inspects the site with its own team and experts. The inspection usually takes place within 60 days of the application. After a positive report, the authority decides on the licence.
Import applications do not always need a site visit. However, CDSCO can inspect an overseas plant, and the applicant pays for that inspection.
Queries are normal. Answer each point directly, attach proof, and avoid long cover letters. A focused reply often closes the matter in one round. Our CAPA guide shows how to present corrective actions in a way auditors accept.
Step 6: Licence Grant, Retention, and Changes After Approval
Once CDSCO is satisfied, it issues the licence on the matching form. Under the Medical Devices Rules, a licence stays valid as long as you pay the licence retention fee every five years. Miss that fee, and the licence can lapse.
Approval is not the end of your duties. You must report serious adverse events, keep complaint records, and run post-market surveillance. You also need approval for major changes, such as a new site, new material, or new sterilisation method. Minor changes usually need only a notice.
Label rules also matter. Rule 44 lists what each label must show, including the licence number, batch number, and dates. Check labels before every new batch or import consignment.
A Simpler Path for Class A Non-Sterile, Non-Measuring Devices
Not every device needs a full licence. Through notification G.S.R. 777(E), the government exempted Class A non-sterile, non-measuring devices from the full manufacturing and import licence process.
Instead, these products need an online registration on the CDSCO portal. You enter basic product data, such as generic name, brand name, model, intended use, material, and shelf life. You do not submit a full Device Master File or Plant Master File for this route.
For many low-risk importers, this is the quickest answer to how to register a medical device with CDSCO in India. This route saves time and money. However, you must still follow labelling rules and quality obligations. The registration also does not cover sterile products or products with a measuring function, such as a thermometer.
For support with this route, see our Class A import registration as per GSR 777(E) and Class A manufacturing registration pages.
CDSCO Registration Fees and Timelines
Budget planning is a practical part of how to register a medical device with CDSCO in India, and it starts with the official fee schedule. The CDSCO registration fees below come from the Second Schedule of the Medical Devices Rules. Consultant charges, testing, and ISO certification costs are extra.
Table 4: Government fees and typical timelines for CDSCO approval
| Route | Fee Per Site | Fee Per Distinct Device | Typical Timeline |
|---|---|---|---|
Manufacture, Class A and B | ₹5,000 | ₹500 | 3 to 6 months |
Manufacture, Class C and D | ₹50,000 | ₹1,000 | 6 to 12 months |
Import, Class A (licensed) | US$ 1,000 | US$ 50 | 6 to 9 months |
Import, Class B | US$ 2,000 | US$ 1,000 | 6 to 9 months |
Import, Class C and D | US$ 3,000 | US$ 1,500 | 9 to 12 months |
Class A non-sterile, non-measuring | Minimal | Minimal | A few weeks |
Timelines depend heavily on file quality. A clean dossier with fast query replies can beat these ranges. A thin file can double them. You can confirm current rules in the CDSCO medical devices FAQ.
What Changed in 2026 for Registering Medical Devices with CDSCO
Several updates affect how you register a medical device with CDSCO in India this year.
EU Approvals Gain Recognition Under Rule 63
India already gave some relief to devices approved in the US, UK, Japan, Australia, and Canada. A 2026 amendment extends this recognition under Rule 63 to devices approved in the European Union. As a result, some EU-approved devices may avoid repeating local clinical investigation. Read our full breakdown of India MDR 2026 and Rule 63.
Clearer Rules for Software
CDSCO released draft guidance in late 2025 on software as a medical device. It separates standalone software from software built into hardware and applies the same A to D risk classes.
Tighter Quality Expectations
Quality system expectations now reach lower-risk Class A products too. Therefore, even small makers should keep a working quality manual, supplier controls, and complaint records.
Common Mistakes When You Register a Medical Device with CDSCO in India
Most delays come from a handful of repeat errors. Avoid these, and your file moves faster.
The first mistake is wrong classification. If you place a device in a lower class, CDSCO rejects it, and you lose the fee and the time. Always check the CDSCO lists and document your reasoning.
The second mistake is grouping devices poorly. Fees apply per distinct device, so poor grouping raises cost. It also creates confusion during review.
The third mistake is a weak Device Master File. Copying an EU or US file without mapping it to Indian formats leaves gaps. Our post on medical device documentation as regulatory evidence shows how to build a file that reviewers can follow.
The fourth mistake is ignoring other approvals. Wireless devices may need WPC approval, and imaging devices may fall under PC-PNDT rules. Check our WPC approval for wireless medical devices page if your device uses Bluetooth or Wi-Fi.
The fifth mistake is slow query replies, since every day you wait adds a day to your timeline.
Should You Use a Consultant to Register a Medical Device with CDSCO?
You can file on your own. Many small Indian makers with one Class A or B device do. However, a consultant helps when the stakes or the complexity rise.
Consider expert help if you are a foreign brand without an Indian office, if your device is Class C or D, or if you plan to launch many models at once. It also helps when your product is software, a combination product, or an in vitro diagnostic. For diagnostics, see our in vitro diagnostic regulatory services.
A good partner does more than fill forms. It checks your class, maps your existing files to Indian formats, prepares audit readiness, and handles queries. Our article on choosing a CDSCO consultant for medical devices lists the questions you should ask before you sign.
If India is one of several target markets, plan your evidence once and reuse it. Our global MedTech regulatory strategy guide explains how to sequence markets.
What Founders and Regulatory Teams Discuss on Reddit
Questions about how to register a medical device with CDSCO in India show up often in online communities. Founders ask about agent costs, timelines, and Class A registration. Regulatory professionals share tips on DMF formats and query replies.
You can follow these discussions in the r/RegulatoryAffairs community and the r/MedicalDevices community. Indian founders also compare notes in r/StartUpIndia. To see the latest posts and comments, use this Reddit search for CDSCO medical device threads.
Always confirm community advice against official CDSCO sources before you file.
Frequently Asked Questions About How to Register a Medical Device with CDSCO in India
What is CDSCO medical device registration?
CDSCO medical device registration is the approval a company needs to make, import, or sell a medical device in India. The Central Drugs Standard Control Organisation grants it under the Medical Devices Rules 2017. Depending on the device and the applicant, the approval can be a manufacturing licence, an import licence, a loan licence, or an online registration for low-risk products. Anyone learning how to register a medical device with CDSCO in India should first confirm the device class, because class decides the form, authority, fee, and audit type.
How long does it take to register a medical device with CDSCO?
The timeline depends on the device class and route. Class A and B manufacturing licences usually take three to six months, including the notified body audit. Class C and D licences often take six to twelve months, because the Central Licensing Authority inspects the site. Import licences generally take six to twelve months. When you plan how to register a medical device with CDSCO in India, remember that clean documents and quick query replies cut these timelines. See our CDSCO manufacturing licence guide for site-readiness tips.
How much does it cost to register a medical device with CDSCO in India?
Government fees start at ₹5,000 per site and ₹500 per device for Class A and B manufacturing. Class C and D manufacturing costs ₹50,000 per site and ₹1,000 per device. Import licences range from US$ 1,000 per site for Class A to US$ 3,000 per site for Class C and D, plus per-device fees. The full cost of how to register a medical device with CDSCO in India also includes testing, ISO 13485 certification, notified body audit fees, and any consultant support.
What is the difference between Form MD-14 and Form MD-15?
Form MD-14 is the application an Indian authorised agent files to import a medical device. Form MD-15 is the import licence that CDSCO issues once it approves that application. In simple terms, MD-14 is the request and MD-15 is the permission. Both apply to Class A, B, C, and D devices, except Class A non-sterile, non-measuring devices that use online registration. This distinction is a core part of how to register a medical device with CDSCO in India as a foreign brand.
Do I need CDSCO registration if my device already has CE marking or FDA clearance?
Yes. Foreign approvals do not replace Indian approval. You still need an import licence or a registration before you sell in India. However, approvals from the US, UK, Japan, Australia, Canada, and now the EU can support your file and may reduce clinical data needs. They also help you get a Free Sale Certificate. So, when you work out how to register a medical device with CDSCO in India, treat your CE or FDA file as a strong starting point. Our EU MDR CE marking process guide explains how to reuse that evidence.
Can a foreign company apply to CDSCO directly?
No. A foreign manufacturer must appoint an Indian authorised agent. The agent needs a valid manufacturing or wholesale licence in India and a power of attorney from the manufacturer. The agent files the MD-14 application, pays fees, answers queries, and handles post-market duties. Picking a reliable agent is a key step in how to register a medical device with CDSCO in India from overseas. Our regulatory solutions for importers page covers agent services.
How do I register a medical device with CDSCO in India?
You learn how to register a medical device with CDSCO in India in four moves: classify the device, choose the right form, prepare the Device Master File and Plant Master File, and file online on the CDSCO MD Online portal. After fees, audits, and query replies, CDSCO issues your licence or registration number.
Which form do I need to import a medical device into India?
You need Form MD-14 to apply for an import licence. CDSCO then grants the licence on Form MD-15. An Indian authorised agent must file the application. Class A non-sterile, non-measuring devices skip this licence and use a simple online registration on the CDSCO portal instead.
Is ISO 13485 mandatory for CDSCO registration?
CDSCO requires a quality management system that meets the Fifth Schedule of the Medical Devices Rules, which follows ISO 13485. A certificate from an accredited body is the easiest way to prove this. In practice, most importers and manufacturers submit an ISO 13485 certificate with their application.
Who approves medical devices in India?
The Central Drugs Standard Control Organisation approves medical devices in India under the Drugs Controller General of India. State Licensing Authorities issue manufacturing licences for Class A and B devices. The Central Licensing Authority handles Class C and D manufacturing licences and all import licences.
Knowing how to register a medical device with CDSCO in India gives you a clear map, but every device brings its own questions about class, evidence, and timing. The fastest approvals come from teams that plan the file before they touch the portal. NKB Regovanta helps manufacturers and importers get this right the first time, from classification to licence grant and beyond. Explore our CDSCO India regulatory services to see every licence route we support, or review our medical device licensing and regulatory approvals in India offering. If you are ready to register a medical device with CDSCO in India this year, talk to our regulatory team and turn your Indian market plan into a licensed product on the shelf.
NKB Regulatory Experts
Verified Regulatory ExpertM.Pharm, RAC (Global Regulatory Affairs Certified)
Senior Regulatory Affairs & Quality Assurance Specialists at NKB Regovanta Solutions Pvt. Ltd., guiding MedTech manufacturers worldwide across CDSCO, US FDA, EU MDR, and ISO 13485 compliance.
Facing medical device compliance bottlenecks or Notified Body review findings?
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