CDSCO

What is CDSCO ?

ARKCA Corporate provides expert consultation to secure CDSCO Registration Certificate for importers, exporters, and manufacturers of medical devices, drugs, and cosmetics. This service ensures compliance with CDSCO regulations under the Drugs and Cosmetics Act, 1940. We guide clients through errorless documentation, regulatory approvals, and online submission, enabling faster customs clearance and clinical trial authorization. With CDSCO Certification, businesses gain trust, legal recognition, and streamlined operations for domestic and international medical trade.

Why CDSCO is needed ?

  1. Legal Market Access
     CDSCO Registration provides legal authorization to sell imported or domestically manufactured medical products in India.
  2. Product Safety Assurance
     Certification ensures products comply with quality standards, enhancing consumer trust and credibility in the market.
  3. Export-Import Facilitation
     Simplifies customs clearance and regulatory compliance for seamless import-export operations of drugs, medical devices, and cosmetics.
  4. Clinical Trial Authorization
     Enables conducting CDSCO-approved clinical trials before launching medical products for distribution or marketing purposes.
  5. Regulatory Compliance Assurance
     Helps businesses adhere to Drugs and Cosmetics Act, 1940, minimizing the risk of penalties, fines, or legal issues.
  6. Business Efficiency Boost
     Streamlines documentation, approvals, and distribution processes, reducing delays and operational bottlenecks in medical trade.

What documents are needed for CDSCO ?

  1. Applicant ID Proof
     Valid identification documents of the applicant, such as PAN card, Aadhar, or Passport, required for verification.
  2. Applicant Address Proof
     Documents confirming the applicant’s registered address, like utility bills or rental agreements.
  3. Undertaking Form
     A government-issued undertaking form confirming adherence to CDSCO regulations and compliance obligations.
  4. Form MD-1
     Completed Form MD-1 required for CDSCO registration application for manufacturers or importers of medical devices and drugs.
  5. Product Description
     Detailed documentation outlining the specifications, composition, and usage of the medical product for regulatory evaluation.
  6. Manufacturing/Wholesale License
     Copy of manufacturing license, wholesale license, or BA/BE approved site registration, depending on the business activity.

Our Clients

Businesses that believe in us

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POLARIS
Ducati
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HAMMER
PURE Source (India)
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Zuventus HealthCare Limited
Hamilton Houseware P. Ltd.
CLEARFAST Air Cargo Agencies Pvt. Ltd.
Ultratech Cement

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