CDSCO Registration for Medical Devices and Cosmetics in India

 All health and beauty industries are booming in India. Such a boom brings along the need for even safer and more quality-compliant products. Registration of medical devices under CDSCO Medical Device Registration becomes highly significant in all these matters. CDSCO (Central Drugs Standard Control Organization) falls under the Ministry of Health and Family Welfare and governs the import, manufacture, and sale of medical devices and cosmetics within India. For marketing such products in the country, all manufacturers and importers require permission from CDSCO.

What is CDSCO and Why Is It Important to Know?

Just as the FDA was created to set up authority for medical devices and cosmetics in the U.S., CDSCO serves as the same in India. It is the national authority responsible for ensuring that the usage of medical devices and cosmetics in the country remains safe, effective, and of high quality.

In today’s era of healthcare modernization and consumer awareness, CDSCO for Medical Devices and cosmetics provides all the necessary safeguards to ensure product credibility and consumer protection.

Moreover, this broad regulation ensures that unsafe or substandard products do not reach the Indian public. Thus, CDSCO plays a vital role in preserving public health and fostering an environment of ethical and transparent trade.

Registration Procedure for CDSCO Medical Devices

The CDSCO Medical Device Registration procedure is crucial for listing medical devices in the Indian market, whether manufactured locally or imported. The registration process follows a step-by-step structure depending on the classification of the device — Class A, B, C, or D — based on the associated risk level.

1. Device Classification:

Medical devices are classified based on their risk and intended use.

  • Class A & B: Low to moderate-risk devices (for example, thermometers, surgical gloves).
  • Class C & D: High to very high-risk devices (for example, stents, implants, diagnostic kits).

2. Appointment of Authorized Indian Agent:

Foreign manufacturers must appoint an Authorized Indian Representative (AIR) as their local contact for all regulatory communications and submissions to CDSCO.

3. Application Requirements:

Applicants are required to submit Form MD-14 (for import) or Form MD-3 (for manufacturing) through the CDSCO online portal, along with supporting documents such as:

  • Device Master File (DMF)
  • Plant Master File (PMF)
  • ISO 13485 Certificate
  • Free Sale Certificate (FSC)
  • Test Reports and Technical Documentation

4. Evaluation and Grant of License:

The CDSCO evaluates the submitted documents and may request clarifications or conduct audits. Upon satisfactory review, a registration certificate (Form MD-15 or MD-5) is issued, granting legal approval to import or sell the medical device in India.

5. Follow-Up After Approval:

After registration, manufacturers must ensure continued compliance through post-market surveillance, regular product testing, labeling conformity, and periodic audits.

CDSCO Cosmetic Registration Process

The CDSCO Cosmetic Registration Process ensures that cosmetic products imported or manufactured in India meet quality and safety standards. This process is governed under the Drugs and Cosmetics Act, 1940, and the Rules, 1945, ensuring consumer safety and transparency.

Step-by-Step Procedure:

1. Identify Product Category:
Identify whether the product falls under skincare, haircare, oral care, or color cosmetics.

2. Appoint Authorized Indian Representative:
Foreign manufacturers must appoint an Authorized Indian Agent to represent them before CDSCO.

3. Filing Application Form (COS-1):
The applicant must submit Form COS-1 through the CDSCO portal along with the following documents:

  • List of ingredients and their concentrations
  • Product labels and specifications
  • Free Sale Certificate (FSC)
  • Manufacturing License from the country of origin
  • Power of Attorney (PoA)

4. Approval and COS-2 Certificate:
After successful evaluation, CDSCO issues the COS-2 Registration Certificate, allowing the company to import and market the cosmetic product legally in India.

Why Choose BR & Associates for CDSCO Registration?

BR & Associates is a trusted regulatory consulting firm specializing in both CDSCO Cosmetic Registration Process and CDSCO Medical Devices Registration. Our experienced team manages the complete registration process—ensuring accuracy, efficiency, and full compliance with Indian regulations.

We handle documentation, dossier preparation, online portal submissions, liaison with CDSCO authorities, and compliance audits. With years of experience in regulatory compliance, we’ve helped clients obtain CDSCO, BIS, EPR, and Legal Metrology registrations across various industries.

Our mission is to simplify complex certification procedures, save time, and ensure 100% compliance with all Indian regulatory norms.

Contact BR & Associates

Get expert guidance today for CDSCO for Medical Devices or Cosmetic Registration with our professional consultants.

📞 Phone: +91-6299905141, +91-9310420570
📧 Email: info@brassociates.co.in
📍 Address: U-44A, Upadhyay Block, Shakarpur, Near Laxmi Nagar Metro Station, New Delhi - 110092
🌐 Website: www.brandassociates.co.in

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