Service Details

CDSCO Registration Services 👇

💊 CDSCO Registration Services

(Central Drugs Standard Control Organization – Ministry of Health & Family Welfare, Government of India)

🇮🇳 What is CDSCO Registration?

The CDSCO (Central Drugs Standard Control Organization) is India’s National Regulatory Authority for pharmaceuticals, cosmetics, and medical devices.
It operates under the Ministry of Health and Family Welfare, Government of India, and ensures that all drugs, cosmetics, and medical devices sold in India are safe, effective, and of standard quality.

The CDSCO Registration is mandatory for manufacturers, importers, and distributors of:

• Drugs & pharmaceuticals

• Medical devices

• Cosmetics

• Blood products

• Vaccines & biologics

🎯 Who Needs CDSCO Registration?

✅ Indian Manufacturers of Drugs / Devices
✅ Foreign Manufacturers exporting to India
✅ Importers, Distributors, or Authorized Indian Agents
✅ Cosmetic or Healthcare Product Companies
✅ Hospitals importing or using regulated medical equipment

🧾 Documents Required for CDSCO Registration

For Indian Manufacturers:

1. Manufacturing License (Form 25/28)

2. Product List and Composition Details

3. Test Reports / Technical Data Sheets

4. Plant Master File & Site Master File

5. GMP / ISO 13485 Certificate

6. Label and Artwork Samples

7. Authorization Letter (if applicable)

For Foreign Manufacturers / Importers:

1. Power of Attorney (POA) in favor of Indian Agent

2. Free Sale Certificate / Marketing Authorization

3. Manufacturing License from Country of Origin

4. Device Master File / Product Dossier

5. Plant Master File

6. ISO 13485 & CE Certificates

7. Undertaking of Product Compliance with BIS / Indian Standards

⚙️ Step-by-Step CDSCO Registration Process

1. Determine Product Classification

   • Check if the product falls under drug, cosmetic, or medical device category.

2. Prepare Documentation

   • Compile technical data, manufacturing details, and compliance certificates.

3. Online Application Submission

   • File the application through the SUGAM Portal (https://cdsco.gov.in).

4. CDSCO Review & Query Resolution

   • Authority reviews the documentation and raises clarifications (if any).

5. Grant of Registration Certificate / License

   • After successful verification, the CDSCO issues the registration approval.

⏳ Processing Time & Validity

🕒 Processing Time: 30–90 working days (depending on product type)
📅 Validity: 3 years (renewable)

💡 Benefits of CDSCO Registration

✅ Legal authorization to manufacture/import regulated products in India
✅ Builds credibility with healthcare institutions and buyers
✅ Ensures compliance with national and global safety standards
✅ Facilitates smooth import/export processes
✅ Required for e-commerce and government tender participation

💼 Our CDSCO Registration Services Include

• Product classification & compliance guidance

• Preparation of technical documentation (DMF / PMF)

• Application filing on SUGAM Portal

• Coordination with CDSCO officials for queries & approvals

• Post-registration renewals & modifications

• Import license and product approval assistance

💰 Fees

• Government Fees: Based on product category and license type

• Professional Fees: Affordable, transparent pricing

📞 Contact for CDSCO Registration Assistance

SAI KUMAR VARALA & CO
✅ CDSCO Registration | Medical Device & Drug License | Import & Manufacturing Approval | Compliance Documentation Support
📱 Mobile: 7337500748
📧 Email: saivarala33@gmail.com