CDSCO CERTIFICATION
[ Table Of Content ]
- Introduction to CDSCO Certification
- Application / Licences for Medical Devices as per CDSCO
- Step-by-Step Registration Process
- Documents Required for CDSCO
- CDSCO License Registration Fees Based on Application
- Time Required for CDSCO Certification Approval
- Importance of a CDSCO Consultant
- Conclusion
- Frequently Asked Questions (FAQ)
Introduction to CDSCO Certification
CDSCO Certification is a mandatory regulatory certification granted by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, Government of India. It ensures that the production, importation, or sale of drugs, medical devices, and cosmetics meets Indian safety, quality, and technical standards.
Without CDSCO approval, products cannot be legally sold in the Indian market. Compliance prevents customs delays and ensures smooth market entry.
Application / Licences for Medical Devices as per CDSCO
Wholesale License
Registration for wholesale distribution of medical devices across India.
Import & Sale
Mandatory license for the import and commercial sale of medical devices.
Manufacturing (Class A & B)
License for manufacturing Class A and B (Low to Moderate Risk) devices.
Manufacturing (Class C & D)
License for manufacturing high-risk Class C and Class D medical devices.
Import for Demonstration
Special license to import devices for exhibition or training purposes.
Test License
For importing small quantities of devices for evaluation and analysis.
Registration Process
Documentation
Prepare all required documents including the device dossier, test protocols, and clinical investigation plans.
Portal Access
Create or verify your account on the CDSCO online SUGAM/NSWS portal to access the application system.
Submission
Fill out Application and upload all required supporting documents on the portal.
Fee Payment
Pay the applicable government fee through the integrated online payment gateway.
Review
The application is reviewed by the CDSCO Central Licensing Authority (CLA) for compliance and completeness.
Query Response
If the regulator raises any queries or clarification requests, submit the required responses and documents.
Grant License
After successful review and approval, the Licence is issued.
Documents Required for CDSCO Registration
To obtain CDSCO registration for medical devices, applicants must submit detailed documentation that allows regulatory authorities to evaluate the safety, quality, and intended use of the device.
Device Description & Specifications
Details about the medical device, including its design, materials, components, and intended use to define its functionality.
Test / Evaluation Protocol
Testing methods and evaluation procedures used to verify the safety, performance, and reliability according to applicable standards.
Clinical Investigation Plan
If required, an outline of objectives, methodology, and safety measures for conducting clinical studies.
Manufacturing Flowchart
A step-by-step production process overview, from raw materials to final inspection and packaging, ensuring quality control.
CDSCO License Registration Fees Based on Application
The cost of CDSCO registration depends on the type of product and the approval required. The Central Drugs Standard Control Organization has established different fee structures for various categories such as drugs, medical devices, and cosmetics.
In general, import registrations tend to have higher fees because they involve more detailed scrutiny and regulatory checks. On the other hand, manufacturing licenses have different fee slabs, which usually depend on the product type or the classification of the medical device.
The total registration cost may also increase if multiple products, product variants, or additional testing requirements are involved. Therefore, it is important for manufacturers and importers to correctly identify the applicable category and fee structure before starting the application process. Reviewing the latest CDSCO fee guidelines helps businesses plan their budget properly and ensures a smoother approval process.
Medical Devices
The registration fees for medical devices vary depending on the device classification (Class A, B, C, or D) and whether the application is for manufacturing or import. The following are approximate CDSCO fee structures.
Manufacturing License Fees (Class A & B Devices)
| Fee Type | Amount |
|---|---|
| License Fee | 5,000 INR |
| Device Fee | 500 INR per device |
Manufacturing License Fees (Class C & D Devices)
| Fee Type | Amount |
|---|---|
| License Fee | 50,000 INR |
| Device Fee | 1,000 INR per device |
Import License Fees
| Device Class | Site Fee | Product Fee |
|---|---|---|
| Class A (Sterile / Measuring) | 83,300 INR per site | 4,165 INR per product |
| Class B Devices | 1,66,600 INR per site | 83,300 INR per product |
| Class C & D Devices | 2,49,900 INR per site | 1,24,950 INR per product |
Drugs
| Fee Category | Amount |
|---|---|
| First Product | 10,000 INR |
| Each Additional Product | 1,000 INR |
Registration Certificate (Form 40)
| Category | Amount |
|---|---|
| Manufacturing Premises | 8,33,000 INR |
| Single Drug (Import & Indian Use) | 4,16,500 INR |
| Each Additional Drug | 4,16,500 INR |
Cosmetics
| Fee Category | Amount |
|---|---|
| Up to 10 Items per Category | 10,000 INR |
| Each Additional Item | 500 INR |
Cosmetics – Import Registration Certificate (Form COS-2)
| Category | Amount |
|---|---|
| First Category | 83,300 INR |
| Each Additional Category | 83,300 INR |
| Each Variant | 4,165 INR |
Manufacturing Site Registration for Imports
| Category | Amount |
|---|---|
| Per Manufacturing Site | 41,650 INR |
Time Required for CDSCO Certification Approval
The time required to obtain CDSCO certification in India depends on the product type, risk classification, and the accuracy of the submitted documents. In most cases, the approval process takes between 1 to 9 months.
Low-risk Class A and Class B medical devices are usually approved within 1–2 months because their regulatory process is simpler. However, Class C and Class D devices, which involve higher risk, require detailed technical and clinical evaluation and may take 3–4 months or sometimes up to 9 months.
For cosmetics, the registration process typically takes 4–6 months, while import licenses may require around 2–3 months. If the application is incomplete or requires additional clarification from authorities, the approval timeline may be extended.
Importance of a CDSCO Consultant
A highly skilled CDSCO consultant guarantees proper product categorisation, proper documentations and expedited approvals. Professional advice will lessen mistakes during the application, decrease the likelihood of rejection and guarantee compliance with regulations in the long run.
Conclusion
All businesses intending to manufacture, import or sell regulated products in India must have CDSCO Certification. It can assure adherence to Indian policies, reduce legal risks and create long-term market credibility.
The CDSCO consultants who handle the documentation, registration and approvals are experienced and hence the certification process is hassle free, accurate and without stress and hence market entry is smooth and long-term regulatory compliance is maintained.
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CDSCO
REGISTRATION
CDSCO Registration is an essential approval for businesses that manufacture, import, or sell medical devices, drugs, and cosmetics in India. Issued by the Central Drugs Standard Control Organization, this registration ensures that products meet the required safety, quality, and regulatory standards before they are introduced into the Indian market.
