CDSCO Medical Device Registration in India

 The new healthcare and beauty markets created in India are completely dependent on the CDSCO Medical Device Registration pathway in relation to product safety and quality compliance. Under the Central Drugs Standard Control Organization (CDSCO), a regulatory body under the Ministry of Health and Family Welfare, drugs, cosmetics, and medical devices marketed in India are approved, regulated, and supervised. A manufacturer or importer is currently required to register a product with CDSCO to market it in India.

Defining and the Significance of CDSCO

Essentially, CDSCO works like the FDA in the USA, overseeing every import, manufacture, and sale of drugs and medical devices. With rising global health awareness and advances in medical technology pouring into the world, CDSCO has become more important than ever. It ensures safety concerning medical devices and cosmetics to meet the basic health standards of the health-conscious Indian user.

Registration Procedure by CDSCO for Medical Devices

For facilitating legal registration, the entire CDSCO for Medical Devices process is divided into several documented steps to be followed by manufacturers and importers. Depending on the classification of the medical device — Class A, B, C, or D — the registration process varies.

Classification of the Device:

Medical devices are classified according to their intended use and associated risk factors.

  • Class A and B: Low to moderate-risk devices (like surgical gloves, thermometers).
  • Class C and D: High to very high-risk devices (like cardiac stents, implants).

Important Indian Agent:

Foreign manufacturers are mandated to appoint a recognized Indian Authorized Representative to deal with all matters concerning the regulatory process, correspondence, and liaison with CDSCO.

Preparation and Submission of Application:

The applicant must file Import Application Form (MD-14) for import or MD-3 for manufacturing through the CDSCO online portal, along with supportive documents including:

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

Approval and Evaluation:

CDSCO reviews the documents and may seek clarification or conduct an audit in exceptional cases. After approval, the registration certificate is issued (Form MD-15 or MD-5), allowing legal manufacturing or importing of the device into the Indian market.

Post-Approval Compliance:

After registration, compliance must be maintained continually through periodic audits, post-market surveillance, and adherence to labeling and reporting requirements.

Registration Process for CDSCO Cosmetic Registration

The CDSCO Cosmetic Registration process is aimed at assuring the safety and quality of cosmetic goods imported or manufactured in India. This registration process is governed under the Drugs and Cosmetics Act, 1940 and Rules, 1945.

Step-wise Procedure:

Classification of Product:

Define the product category under cosmetics — for example, skincare, haircare, oral care, or color cosmetics.

Appointed Representative:

Foreign manufacturers must appoint an authorized Indian agent to represent them before CDSCO. The representative must submit Form COS-1, along with supporting documents such as:

  • List of ingredients with concentrations
  • Product label and specification
  • Manufacturing license from the country of origin
  • Free Sale Certificate
  • Power of Attorney (PoA)
Upon Evaluation & COS-2 Certificate:

After evaluation, CDSCO issues the COS-2 Registration Certificate, which authorizes a company to import and sell cosmetic products in India.

Why Trust BR & Associates?

BR & Associates specializes in facilitating CDSCO Cosmetic Registration and CDSCO Medical Device Registration for both Indian and foreign companies. Our experts guide clients through every step — from document preparation and application submission to final approval — ensuring that all requirements laid down by CDSCO are met.

With years of experience in regulatory consulting, we have successfully helped numerous clients obtain CDSCO certifications, BIS licenses, EPR authorizations, and Legal Metrology registrations. We believe that every company deserves a smooth and compliant entry into the Indian market.

Contact BR & Associates

Engage us now for professional consultation on CDSCO for Medical Devices or Cosmetic Registration.

📞 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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