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CDSCO Registration for Medical Products in India

Ensure compliance for your medical products with Aone Filing’s expert CDSCO Registration services. Register with the Central Drugs Standard Control Organisation (CDSCO) to manufacture, import, or distribute medical devices and drugs in India. Contact our experts at +91-9211963599 for assistance.

Overview

The Central Drugs Standard Control Organisation (CDSCO) is India’s regulatory authority for pharmaceuticals and medical devices, ensuring safety, efficacy, and quality. CDSCO Registration is mandatory for businesses involved in manufacturing, importing, or distributing drugs and medical devices in India, enabling compliance with the Drugs and Cosmetics Act.

What is CDSCO?

The CDSCO, under the Ministry of Health and Family Welfare, regulates the import, manufacture, sale, and distribution of drugs and medical devices in India. It ensures compliance with regulatory standards, conducts inspections, and issues licenses for medical products.

CDSCO Registration

CDSCO Registration is required for manufacturers, importers, and distributors of drugs and medical devices to ensure compliance with Indian regulations. It involves obtaining licenses like Form 10 (import), Form 28 (manufacturing), or Form 20B/21B (distribution), depending on the business activity.

Benefits of CDSCO Registration

Regulatory Compliance

Meet legal requirements for manufacturing and distribution.

Market Access

Enable legal sale and import of medical products in India.

Consumer Safety

Ensure products meet safety and quality standards.

Global Credibility

Enhance trust with international partners and regulators.

Trade Facilitation

Simplify import and export processes with CDSCO licenses.

Categories of Products Requiring CDSCO Registration

  • Drugs (pharmaceuticals, vaccines, etc.)
  • Medical devices (Class A, B, C, D)
  • In-vitro diagnostic kits
  • Cosmetics (as per Drugs and Cosmetics Act)
  • Blood and blood products

Eligibility for CDSCO Registration

  • Manufacturers, importers, or distributors of drugs or medical devices.
  • Businesses with a valid Import Export Code (IEC) for import activities.
  • Compliance with the Drugs and Cosmetics Act and Medical Device Rules.

Documents Required

  • Duly filled and signed application form (Form 40 for devices, Form 8 for drugs).
  • Copy of Import Export Code (IEC) for importers.
  • Manufacturing license or WHO-GMP certificate (if applicable).
  • PAN Card of the business entity.
  • GST Registration Certificate.
  • Product details and technical specifications.
  • Proof of premises (rent agreement or ownership documents).
  • Power of Attorney (for authorized agents).

Contact our advisors at +91-9211963599 for a detailed document checklist.

Procedure for CDSCO Registration

  1. Consult with our experts to understand eligibility and requirements.
  2. Submit required documents for verification.
  3. Application filing through CDSCO’s online portal (SUGAM).
  4. Receive CDSCO license or registration upon approval.

Why Choose Aone Filing?

Aone Filing provides expert guidance from Chartered Accountants, Lawyers, and Company Secretaries to streamline your CDSCO Registration process. With extensive experience, we ensure compliance with CDSCO regulations, enabling you to manufacture, import, or distribute medical products seamlessly. Contact us at +91-9211963599 or info@aonefiling.com for expert support.

Frequently Asked Questions (FAQ)

Manufacturers, importers, and distributors of drugs and medical devices require CDSCO Registration.

Yes, CDSCO Registration is mandatory for all medical devices under the Medical Device Rules, 2017.

CDSCO licenses are typically valid for three years, subject to renewal.

Yes, CDSCO Registration can be applied for online through the SUGAM portal. Contact our experts at +91-9211963599 for assistance.