Chat on WhatsApp Call Us

CDSCO Registration
Your Trusted Partner for Hassle-Free CDSCO Registration


The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority responsible for approving and regulating the import, manufacture, distribution, and sale of medical devices, cosmetics, pharmaceuticals, and certain healthcare products. Businesses dealing with regulated products must obtain the necessary CDSCO approvals before entering the Indian market.

CDSCO Registration ensures that your products comply with the quality, safety, and performance standards prescribed by the Government of India. It is mandatory for manufacturers, importers, and authorized agents dealing with products notified under the Medical Devices Rules, 2017 and other applicable regulations.

At Realgreno LLP, we provide end-to-end assistance with CDSCO Registration, helping businesses navigate regulatory requirements, prepare documentation, and obtain approvals quickly and efficiently.

Why is CDSCO Registration Important?

  • Mandatory for regulated medical devices and healthcare products.
  • Ensures compliance with Indian regulatory standards.
  • Enables legal import, manufacture, and sale of products in India.
  • Enhances product credibility and customer confidence.
  • Facilitates faster market entry and business expansion.
  • Reduces the risk of regulatory penalties and non-compliance.

Who Should Apply?

CDSCO Registration is required for:

  • Medical Device Manufacturers
  • Medical Device Importers
  • Cosmetic Importers
  • Pharmaceutical Companies
  • Authorized Indian Representatives (AIR)
  • Healthcare Product Suppliers
  • Foreign Manufacturers Entering the Indian Market

Documents Required

The required documents may vary depending on the product category and applicant. Generally, the following are required:

  • Company Incorporation Certificate
  • PAN Card
  • GST Registration Certificate
  • Manufacturing License (if applicable)
  • Product Details and Technical Specifications
  • ISO 13485 Certificate (where applicable)
  • Free Sale Certificate (for Imported Products)
  • Power of Attorney / Authorized Indian Representative (AIR) Letter
  • Product Labels and Packaging Details
  • Test Reports and Quality Documents

CDSCO Registration Process

  • Product Classification & Eligibility Assessment
  • Documentation Preparation
  • Application Filing with CDSCO
  • Technical Review & Regulatory Evaluation
  • Clarification or Additional Information (if required)
  • Approval & Issuance of Registration/License

Benefits of CDSCO Registration

  • Legal authorization to market products in India.
  • Compliance with Indian medical device regulations.
  • Improved brand reputation and customer trust.
  • Smooth import and distribution process.
  • Increased business opportunities in the healthcare sector.
  • Faster access to the Indian market.

Get Your CDSCO Registration Today

Expand your healthcare business with confidence by obtaining CDSCO Registration. Our experts ensure a smooth, transparent, and hassle-free registration process, helping you bring your products to the Indian market without unnecessary delays.

How Realgreno LLP Can Help

Our experienced team provides complete assistance throughout the CDSCO registration process, including:

  • Product Classification Support
  • Regulatory Consultation
  • Documentation Preparation
  • Application Filing
  • Coordination with CDSCO Authorities
  • Compliance Review
  • Import License Assistance
  • Ongoing Regulatory Support

At Realgreno LLP, we simplify the CDSCO registration process by managing every stage with accuracy and professionalism. From document preparation to final approval, we help you achieve regulatory compliance while saving time, reducing complexity, and ensuring a seamless market entry.