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Get complete assistance for CDSCO Test License approval in India for drugs and medical devices. From eligibility check to SUGAM portal submission and final approval, we ensure a smooth, compliant, and stress-free regulatory process under CDSCO guidelines for 2026.
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Imagine you have developed a new medical device or drug and want to test it in India before selling it commercially. You cannot simply import or manufacture it without permission, even in small quantities. This is where the CDSCO Test License comes in. Issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, this license gives manufacturers and importers the legal right to produce or bring in small quantities of drugs or medical devices for testing, evaluation, demonstration, clinical investigation, or training purposes only and not for sale.
Without this license, your product is considered illegally imported or manufactured under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. The CDSCO test license is your gateway to lawfully testing a product in India before you go through the longer, more expensive process of obtaining a full commercial license. Whether you are a pharma company testing a new molecule, a medical device startup evaluating a prototype, or a foreign company exploring the Indian market, this license is your first mandatory step. This guide breaks down everything you need to know, in plain, simple language.
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It functions under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, headquartered in New Delhi.
A CDSCO Test License is required by anyone who wants to manufacture or import drugs or medical devices in India for testing purposes only, not for sale. The following groups of people and organizations need this license :
There are two main categories, one for drugs and one for medical devices : each with sub-types for manufacturing and importing.
To apply for a CDSCO Test License, you must meet the following conditions :
Gather all required documents as listed above. Make sure the Form 12 is signed and stamped by the authorized signatory of your company.
Visit the official CDSCO SUGAM portal. Create a new account if you do not already have one. Complete your manufacturer or importer profile.
Pay the required government fees via TR-6 challan at the Bank of Baroda, KG Marg, New Delhi, or any notified branch. Attach the signed and bank-stamped challan to your application.
Fill out the application in Form 12 or Form CT-16 on the SUGAM portal. Upload all supporting documents.
CDSCO will review your application. If there are any missing documents or technical questions, a query letter will be issued. You must respond to all queries within the stipulated timeline.
Once CDSCO is satisfied with your application and documents, Form 11 or CT-17 will be issued electronically via the SUGAM portal.
Create and verify your account on the CDSCO SUGAM portal and complete your company profile.
Identify the correct risk class of your medical device : Class A (lowest risk), B, C, or D (highest risk) : under the Medical Devices Rules, 2017.
Prepare all required documents including device description, test protocol, QMS certificate, IFU, and quantity justification.
File the online application in Form MD-12 (for manufacturing) or Form MD-16 (for importing) through the SUGAM portal. Upload all documents and pay the applicable government fees.
CDSCO will review the application. Technical or regulatory queries may be raised. You must respond accurately and on time.
Upon satisfactory review, CDSCO will issue the test license : Form MD-13 (for manufacturing) or Form MD-17 (for importing) : electronically through the SUGAM portal.
Without this license, even importing one unit of a medical device or drug sample for testing is illegal. The test license gives you full legal protection.
You get a structured, legal framework to test whether your product is safe, effective, and performs as intended : before investing in full commercial manufacturing.
R&D teams and Contract Research Organizations (CROs) can conduct clinical trials, bioequivalence studies, and performance evaluations legally under this license.
Medical devices and drug samples imported under a valid CDSCO test license will not face customs issues or seizures at Indian ports.
Having this license shows that your company follows Indian regulatory laws. This builds trust with CDSCO, hospitals, testing labs, and future business partners.
After successful testing and evaluation, you can use the data gathered under the test license to apply for a full manufacturing or import license from CDSCO.
Before a commercial launch, you can demonstrate your product to distributors, hospitals, and healthcare professionals : legally and compliantly.
Since the product has been thoroughly tested before market entry, the risk of safety issues or regulatory action after the commercial launch is significantly reduced.
Manufacture small quantities of medical devices for testing, evaluation, demonstration, or training
Import small quantities of medical devices for testing, clinical investigation, or training
Go to the CDSCO SUGAM portal (https://cdscomdonline.gov.in), the official website for medical device and drug regulatory submissions in India.
Click on "New Registration" and fill in your company details, type (manufacturer or importer), and contact information.
Fill in your company's manufacturing or import profile, GST details, and authorized signatory information.
Upload all required documents in the prescribed format. Make sure file sizes and formats comply with the portal's requirements.
Pay the applicable government fees online through the portal.
Log in regularly to check your application status. Respond to any queries raised by CDSCO through the portal itself.
Once approved, your test license will be issued electronically and can be downloaded from the portal.
Get expert assistance with CDSCO Test License registration for drugs and medical devices in India. Our compliance specialists handle the entire process—from documentation preparation to SUGAM portal submission and approval tracking—so your business stays fully compliant with CDSCO requirements under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.
📞 Call: 8796104190📧 Email: support@psrcompliance.com
No. Drugs imported under Form 11 are exclusively for examination, testing, and analysis. Commercial sale is strictly prohibited.
Yes, but only with IAEC (Institutional Animal Ethics Committee) approval or CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) permission. A copy of the subject drug must also be provided.
No. Form 11 cannot be renewed. You must apply fresh with a new TR-6 challan and all required documents.
A maximum of 10 different drugs can be imported under a single Form 11 license.
Yes. Form MD-13 allows Indian manufacturers to produce small quantities of Class A, B, C, or D medical devices for testing and evaluation purposes only.
You must respond to the query letter with a point-by-point reply, attaching the original query letter, your application reference, and a covering letter with the file number.
Not directly. A foreign company must appoint an Indian Authorized Agent who can apply on its behalf.
The rule permits "small quantities." If you are importing a larger quantity, you must provide detailed justification through a notarized undertaking with specific test parameters, batch sizes, and number of batches.
You must submit a notarized agreement between your company and the testing facility.
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