How to Get CDSCO License in India: Complete Guide for Medical Devices and Drugs
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How to Get CDSCO License in India: Complete Guide for Medical Devices and Drugs
Introduction: Why a CDSCO License is Crucial
If you’re planning to manufacture or import drugs or medical devices in India, obtaining a CDSCO license is a legal necessity. Issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, this license ensures that your product complies with Indian safety, efficacy, and quality standards.
Whether you’re a domestic manufacturer or a foreign exporter, this guide outlines the exact steps on how to get a CDSCO license in India, including costs, documentation, types of licenses, and applicable regulatory bodies.
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The CDSCO license in India authorizes companies to import, manufacture, or distribute pharmaceuticals and medical devices. The licensing framework is governed by:
Drugs and Cosmetics Act, 1940
Medical Devices Rules, 2017
The CDSCO regulates all Notified Medical Devices, New Drugs, and Biological Products to ensure public health and safety
Types of CDSCO Licenses
1. Drug Manufacturing & Import License
If you deal in pharmaceuticals, the following forms may apply:
Form 25: License to manufacture drugs for sale.
Form 28: For manufacturing drugs specified in Schedule C & C(1) (e.g., biological products).
Form 10: For importing drugs into India.
To get a CDSCO drug license, applicants must comply with Good Manufacturing Practices (GMP) and submit stability data and product details.
2. Medical Device License
Since the Medical Devices Rules 2017, devices are classified into four categories (Class A to D) based on risk.
Form MD-5 / MD-9: For manufacturing medical devices in India.
Form MD-15: For importing medical devices into India.
Foreign manufacturers must appoint an Indian Authorized Agent with a valid wholesale/manufacturing license.
How to Get CDSCO License: Step-by-Step Process
The CDSCO license application process depends on whether you’re importing or manufacturing:
Step 1: Product Classification
Use the CDSCO portal or consult an expert to determine:
Drug or Device?
Risk classification (Class A–D)
Step 2: Register on SUGAM Portal
All applications must be made via the SUGAM portal. Create a login under the appropriate category.
Step 3: Documentation Preparation
Typical documents include:
Covering Letter
Product Label & Specification Sheet
Power of Attorney
Indian Authorized Agent Agreement
Testing Protocols
Step 4: Fee Payment
Fees vary based on product type and quantity. Details are in the next section.
Step 5: CDSCO Review & Approval
CDSCO will review the application and may request clarifications. Once approved, the license is valid for 3–5 years, depending on type.
CDSCO Medical Device License Fees (Indicative)
Note: Fees are indicative and subject to change. Always verify on the official CDSCO or SUGAM portal.
| License Type | Approximate Fee (INR) |
|---|---|
| Form MD-15 (Import License) | ₹50,000–₹1,50,000 |
| Form MD-9 (Manufacturing License) | ₹5,000–₹25,000 |
| Form 10 (Drug Import License) | ₹1,000–₹10,000 |
| Form 25 (Manufacturing License) | ₹6,000–₹15,000 |
Why Choose a Consultant for CDSCO Licensing?
The process is regulatory-heavy and time-sensitive. Minor errors in documentation can cause months of delay. A qualified consultant helps:
Identify correct license type
Classify devices
Ensure ISO/GMP compliance
Navigate the SUGAM portal
Coordinate with CDSCO or SLA (State Licensing Authority)
Conclusion: Unlock Indian Market Compliance Today
Navigating CDSCO license India requirements is vital for any pharmaceutical or medical device business eyeing the Indian market. Whether you need a drug manufacturing license, medical device import license, or just consultation on forms and classification, professional help can reduce costs, save time, and avoid rejections.
