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CDSCO LICENCE

The CDSCO licence is a mandatory requirement for manufacturing, importing, and selling medical devices, cosmetics, and pharmaceuticals in India. The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority responsible for granting these licenses.

Types of CDSCO Licences:

  • Manufacturing Licence: Required for manufacturing medical devices, cosmetics, and pharmaceuticals in India ¹.
  • Import Licence: Required for importing medical devices, cosmetics, and pharmaceuticals into India ¹.
  • Clinical Trial Licence: Required for conducting clinical trials in India.

Eligibility Criteria for CDSCO Registration

  • Manufacturers having a registered office in India
  • Authorized agents of manufacturers
  • Foreign enterprises holding Indian subsidiaries
  • Corporates: Engaged in manufacturing, importing, or selling medical devices, cosmetics, and pharmaceuticals.
  • Importers: Importing medical devices, cosmetics, and pharmaceuticals into India.

Documents Required for CDSCO Registration

  • Form MD 1: Application form for CDSCO registration.
  • Identity and Address Proof: Of the applicant.
  • Covering Letter: Explaining the purpose of registration.
  • Product Description: Detailed description of the product.
  • Test Protocol: Protocol for testing the product.
  • Quality Certificates: Certificates ensuring the quality of the product.
  • Instructions for Use: Instructions for using the product.
  • Undertaking: From the government authority.

Fees for CDSCO Registration

  • Government Fees: Vary depending on the type of registration and device class.
  • Professional Fees: Vary depending on the type of registration and complexity of the application.

Benefits of CDSCO Registration

  • Ensures Quality and Safety: Of medical devices, cosmetics, and pharmaceuticals.
  • Compliance with Regulatory Requirements: Ensures compliance with Indian regulations.
  • Increased Reliability and Market Access: Enhances market access and reliability.
  • Protection of Public Health: Ensures protection of public health.

CDSCO Registration Process

  • Application Submission: Submit the application with required documents.
  • Scrutiny: CDSCO scrutinizes the application.
  • Inspection: CDSCO conducts an inspection of the manufacturing facility.
  • Grant of Registration: CDSCO grants registration upon successful inspection.

Timeline for CDSCO Registration

  • Application Processing: 3-6 months.
  • Inspection: 1-3 months.
  • Grant of Registration: 1-2 months.