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HomeCompulsory RegistrationsCDSCO Registration in India 2025 A Complete Guide

CDSCO Registration in India 2025 A Complete Guide

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Compulsory Registrations

1. 📘 Introduction

The Central Drugs Standard Control Organization (CDSCO) is India’s apex drug regulatory authority under the Ministry of Health and Family Welfare. It governs the import, manufacturing, distribution, and sale of drugs, medical devices, and cosmetics across India.

🔄 2025 Update: CDSCO now mandates online e-Governance portal filing for registration applications under the Medical Device Rules, 2017 (updated in 2023).

Whether you’re an Indian pharma company or a foreign manufacturer, CDSCO registration is essential to legally market and distribute your products in India.

2. 🏷️ Types of Licenses Offered

License TypePurpose
Drug Import LicenseFor importing drugs into India
Medical Device RegistrationFor medical equipment (Class A, B, C & D)
Cosmetic Import RegistrationFor foreign cosmetic brands
Test LicenseFor clinical trial or testing purposes
Wholesale Drug LicenseFor wholesale distribution
Manufacturing LicenseFor local drug/cosmetic production
Registration Certificate (RC)For foreign manufacturers

3. 👤 Who Needs These Services?

  • Pharmaceutical manufacturers/importers
  • Medical device startups or distributors
  • Foreign cosmetic companies entering Indian market
  • Healthcare institutions or hospitals importing devices
  • E-commerce platforms selling medical/cosmetic goods

4. 🧑‍💼 Why Choose a License Registration Service Provider?

While CDSCO provides an online portal, navigating regulatory paperwork is complex. Hiring professionals like Opriya Trending Pvt Ltd offers benefits like:

  • End-to-end documentation support
  • Dossier preparation and review
  • Product classification guidance
  • Liaisoning with CDSCO & DCGI officials
  • Post-registration compliance help

⚠️ Mistakes in application can cause 6+ months delay or legal rejections.

5. 📝 CDSCO Registration Process

  1. Identify your product category (Drug, Device, Cosmetic)
  2. Classify device based on risk class (A to D)
  3. Create account
  4. Submit online application through SUGAM portal
  5. Upload documents + pay fee
  6. Product dossier is reviewed by CDSCO officials
  7. License issued digitally with QR verification

🧾 New Rule (2023): Class A & B devices can be self-certified, but Class C & D need inspection.

6. 📑 Required Documents

DocumentRequired
Duly filled application form✅
Covering letter & authority letter✅
Importer Exporter Code (IEC)✅
Manufacturing license (if applicable)✅
Free Sale Certificate (for imported goods)✅
Product labels, safety & efficacy data✅
Site Master File, Plant Master File✅
Clinical test reports (if required)✅

7. 💰 Cost Involved

ServiceFee (Approx.)
Medical Device Class A & B₹1,000–₹10,000
Class C & D Registration₹50,000+
Cosmetic Import License₹2,500 per product
Drug Import License₹10,000–₹25,000
Consultancy Charges (optional)₹5,000–₹20,000

8. ⏱ Time Taken

StageTimeline
Documentation Prep3–7 days
Application Filing1–2 days
CDSCO Review3–8 weeks (Class A/B)
High Risk Products (Class C/D)2–6 months

9. ❌ Common Mistakes to Avoid

  • Selecting wrong product category or device class
  • Incomplete dossier or missing test reports
  • Ignoring post-approval compliance (like annual returns)
  • Not updating manufacturer address or label changes
  • Using old formats not aligned with 2023 guidelines

10. 📞 Call-to-Action (CTA)

Want expert help with your CDSCO Registration or need faster approval?

📧 Email: opriyatrendingpvtltd@gmail.com
📱 WhatsApp: +91 7588756518
🌐 Website: www.opriyatrending.in

We also assist with FSSAI, AYUSH, FDA, Import Licenses, and clinical trial submissions.

11. ❓ Frequently Asked Questions (FAQs)

Q1. Is CDSCO registration mandatory for all medical devices?

Yes, as of 2023, all Class A-D medical devices need CDSCO approval.

Q2. Can I apply online for CDSCO registration?

Yes. Use the official portal for online applications.

Q3. How long is the CDSCO license valid?

Usually 3 years, but it varies based on license type.

Q4. Can I import cosmetics without CDSCO license?

No. All imported cosmetic products must have registration under CDSCO.

Q5. Are foreign manufacturers required to register?

Yes. They must appoint an Indian Authorized Agent and obtain a Registration Certificate (RC).

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