The CDSCO certification process is the licensing route under India’s Medical Devices Rules, 2017. You classify your device (Class A, B, C, or D), prepare a technical dossier, apply on the CDSCO online portal, go through scrutiny and inspection, and receive a manufacturing or import license. Low-risk devices (Class A and B) are largely handled by State Licensing Authorities for manufacturing, while Class C and D go to the central authority.
If you’re planning to make or bring a medical device into India, CDSCO is the name you’ll hear first. At UMSPCS, most first-time clients arrive with the same worry: “I don’t know where to begin.” So let’s begin at the start.
What is CDSCO?
CDSCO stands for the Central Drugs Standard Control Organisation. It works under the Ministry of Health and Family Welfare and is headed by the Drugs Controller General of India (DCGI). It regulates drugs, medical devices, cosmetics, and clinical trials in the country. When people say CDSCO certification process, they usually mean a CDSCO license or registration, because the regulator issues approvals under specific forms rather than a single certificate.
Is CDSCO registration mandatory for medical devices?
Yes. Under the Medical Devices Rules, 2017, every medical device sold in India needs a license. This was rolled out in phases. Class A and B devices came under mandatory licensing from 1 October 2022, and Class C and D followed on 1 October 2023. Manufacturing or importing without the correct license is an offence under the Drugs and Cosmetics Act, 1940.
Step 1: Know your device class
Everything depends on classification, so get this right first.
- Class A: low risk (for example, thermometers, bandages)
- Class B: low to moderate risk (for example, certain infusion sets)
- Class C: moderate to high risk (for example, ventilators)
- Class D: high risk (for example, heart valves)
CDSCO has published lists of classified devices. If yours isn’t on the list, you can seek classification guidance from the authority. Misclassifying a device is one of the most common reasons applications stall.
Step 2: Identify the route
- Indian manufacturer, Class A or B: apply to the State Licensing Authority. The application is on Form MD-3, and the license comes on Form MD-5.
- Indian manufacturer, Class C or D: apply to the Central Licensing Authority on Form MD-7. The license is issued on Form MD-9.
- Importer or overseas manufacturer: apply on Form MD-14. The registration/import license is issued on Form MD-15. Foreign manufacturers need an authorised Indian agent holding a valid wholesale license.
Read more: Drug license price
Step 3: Prepare the documents
A weak dossier causes more delays than anything else. Typically you’ll need:
- Company constitution documents and premises proof
- Device Master File and Plant Master File
- Quality Management System details (ISO 13485 is commonly expected, especially for importers)
- Risk management file and test reports
- Free Sale Certificate and approvals from reference countries (for imports)
- Labelling and Instructions for Use
- Power of attorney for the Indian agent, where applicable
Step 4: Apply online and pay fees
Applications are filed on the CDSCO medical device online portal. Fees depend on device class and whether you’re manufacturing or importing, so check the current fee schedule instead of relying on old blog posts, ours included.
Step 5: Scrutiny and queries
Officials review the file and often raise queries. You respond with clarifications or additional documents. A clear, complete reply the first time keeps the clock moving. Vague replies send you back to the start of the queue.
Step 6: Inspection and audit
For manufacturing licenses, an inspection of your facility is carried out, sometimes with a notified body. For Class C and D, the Central Licensing Authority is involved directly. Inspectors look at your quality system, production controls, testing capability, and records.
Step 7: License grant
Once everything is satisfactory, the license is issued. Import licenses are valid perpetually, provided you pay the retention fee at the required interval. After approval, you must keep up with post-market obligations such as reporting adverse events, handling complaints, and managing recalls when needed.
How long does it take?
There’s no honest fixed answer. Class A and B applications can move relatively quickly if the file is clean, while Class C and D often take several months because of deeper review and inspection. Delays almost always trace back to incomplete documents or unanswered queries.
Read more: FMCS Registration Process
Mistakes we see often
- Guessing the device class instead of confirming it
- Submitting inconsistent information across forms and technical files
- Ignoring the need for an Indian authorised agent for imports
- Treating the license as a one-time task and neglecting post-market duties
How UMSPCS can help
UMSPCS supports manufacturers and importers through classification, dossier preparation, portal filing, query handling, and inspection readiness. We’d rather spend extra time upfront than watch a client lose months to a rejected application.
Frequently Asked Questions
- What is the CDSCO certification process in simple terms?
Classify the device, compile documents, apply online, respond to queries, pass inspection where required, and receive your license. - Is CDSCO approval required to import medical devices?
Yes. Importers need a valid registration and import license (Forms MD-14 and MD-15) before bringing devices into India. - Who issues licenses for Class A and B devices?
For manufacturing, the State Licensing Authority. For import, the Central Licensing Authority. - Does an FDA or CE approval replace CDSCO approval?
No. Those approvals can support your application, but a CDSCO license is still needed. - Do I need ISO 13485?
It’s widely expected, particularly for overseas manufacturers, and it helps demonstrate a working quality system. - Can a foreign manufacturer apply directly?
They apply through an authorised agent in India, who also holds the necessary license. - Does the license expire?
Import licenses are generally perpetual with periodic retention fees. Always confirm the current validity terms for your license type.
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