CDSCO (Central Drugs Standard Control Organisation) registration is a mandatory
requirement for manufacturing, importing, and selling medical devices, cosmetics,
and pharmaceuticals in India.
Types of CDSCO Registration
Manufacturing License: Required for manufacturing medical devices, cosmetics, and
pharmaceuticals in India.
Import License: Required for importing medical devices, cosmetics, and
pharmaceuticals into India.
Clinical Trial Registration: Required for conducting clinical trials in India.
Eligibility Criteria for CDSCO Registration
Manufacturers: Having a registered office in India.
Authorized Agents: Of manufacturers.
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.
