CDSCO Registration for Cosmetics and Medical Devices in India


India's growing healthcare and personal care sectors have made it essential for companies to obtain proper regulatory approvals before introducing their products in the Indian market. Whether you’re importing skincare products or manufacturing surgical equipment, approvals from the Central Drugs Standard Control Organization (CDSCO) are mandatory. Understanding the CDSCO cosmetic Registration process, as well as the procedure for CDSCO Medical Device Registration, is crucial to stay compliant and avoid legal issues.

This article outlines the regulatory process and explains how BR & Associates can help you obtain these registrations smoothly and efficiently.

Understanding CDSCO and Its Role

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is the national regulatory authority for drugs, cosmetics, and medical devices in India. It ensures that only safe and quality products are manufactured, imported, and sold in the Indian market.

For both cosmetics and medical devices, the CDSCO has laid out a defined procedure for registration that businesses must follow before product launch.

CDSCO Cosmetic Registration Process

The CDSCO cosmetic Registration process applies to all imported cosmetics entering the Indian market under the Drugs and Cosmetics Act, 1940. Without this registration, imported cosmetic products cannot be sold or distributed in India.

Step-by-Step Process:

  1. Appointment of Authorized Agent:
    Foreign manufacturers must appoint an Authorized Indian Representative (AIR) to handle regulatory communication with CDSCO.
  2. Document Preparation:
    Required documents include:
    • Application Form COS-1
    • Free Sale Certificate from the country of origin
    • Ingredient list and product label
    • Product specifications and test reports
    • Power of Attorney
  3. Online Submission:
    The complete application must be submitted through the SUGAM portal managed by CDSCO.
  4. Review and Approval:
    Upon successful verification, CDSCO issues the COS-2 registration certificate. The review process typically takes 3–6 months.

CDSCO Medical Device Registration

The CDSCO Medical Device Registration is regulated under the Medical Devices Rules, 2017. CDSCO classifies medical devices into four risk-based categories:
Class A (low risk), Class B (low-medium), Class C (medium-high), and Class D (high risk).

Steps for Registration:

  1. Device Classification:
    Identify the correct risk category of your medical device.
  2. Application Forms:
    • For imported devices: Use Form MD-14
    • For domestic manufacturing: Use Form MD-3
  3. Documentation:
    • Device Master File
    • ISO 13485 certification
    • Free Sale Certificate
    • Clinical performance data (for Class C and D devices)
  4. Review and Licensing:
    After review and inspection (if required), CDSCO grants approval via Form MD-15 or MD-5, depending on the application type.

Getting CDSCO approval for medical devices is essential for market entry, regulatory protection, and user safety.

Why CDSCO for Medical Device and Cosmetic Compliance Matters

Failure to obtain appropriate CDSCO approvals can result in:

  • Regulatory penalties
  • Customs clearance delays
  • Loss of market trust
  • Product recalls

Thus, following the proper registration procedure is vital for both imported and domestically produced items.

How BR & Associates Can Help

BR & Associates offers complete consulting support for CDSCO registration processes. Whether you're seeking assistance with the CDSCO cosmetic Registration process, CDSCO Medical Device Registration, or overall compliance with CDSCO for Medical Device, our team ensures that you meet all regulatory requirements efficiently.

Our Services Include:

  • CDSCO SUGAM portal registration
  • Technical documentation and application preparation
  • Indian Authorized Agent services
  • Communication with regulatory authorities
  • Post-approval renewals and compliance

Contact details

+91-6299905141
+91-9310420570
info@brassociates.co.in
U-44A, Upadhyay Block, Shakarpur, Near Laxmi Nagar Metro station, New Delhi-110092

Location: Metro Station Laxmi Nagar, Veer Savarkar Block, Delhi, 110092

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