CDSCO Application

CDSCO Registration refers to the applicable registration, License, permission or approval process administered by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India. CDSCO regulates various categories of products and activities, including drugs, medical devices, in-vitro diagnostic devices, cosmetics and certain related activities. The exact approval required depends on the product category, its risk classification and the activity being undertake.

• Drug manufacturers
• Drug importers
• Medical device manufacturers
• Medical device importers
• In-vitro diagnostic (IVD) device manufacturers
• IVD device importers
• Foreign manufacturers supplying regulated products to India
• Authorized Indian agents of foreign manufacturers
• Businesses dealing with products covered under applicable CDSCO regulations

• 1. Drug Import Registration and License CDSCO processes applicable registration and import License applications for drugs imported into India through the prescribed regulatory process.
• 2. Medical Device Import License Applicants importing medical devices may need to apply for the appropriate import License. Under the Medical Devices Rules framework, an application for import License is made through the SUGAM portal under the applicable form and procedure.
• 3. Medical Device Manufacturing License Manufacturers of medical devices may require a License from the appropriate licensing authority, depending on the device classification and applicable regulatory requirements.
• 4. In-Vitro Diagnostic Device Approval Manufacturing or importing specified IVD devices may require applicable CDSCO approval, License or registration.
• 5. Test License and Clinical Investigation Permissions CDSCO also provides regulatory pathways for importing or manufacturing certain products for testing, evaluation, clinical investigation, examination, demonstration or training purposes.

• 1. Regulatory Compliance Obtaining the applicable CDSCO approval helps businesses comply with relevant Indian regulatory requirements.
• 2. Legal Market Access For products requiring mandatory approval, the appropriate CDSCO License or registration can be necessary before the product is legally manufactured or imported.
• 3. Builds Market Credibility Regulatory compliance can help demonstrate that the business is following applicable quality, safety and regulatory requirements.
• 4. Supports Product Import The appropriate CDSCO approval can facilitate the lawful import of regulated products into India.
• 5. Supports Business Expansion CDSCO approval can help eligible manufacturers and importers access the Indian healthcare and medical products market.
• 6. Improved Consumer Confidence Compliance with applicable regulatory requirements can contribute to greater confidence in regulated products.

1. Step 1: Identify the Product Category Determine whether the product is regulated as a drug, medical device, IVD or another product category.
2. Step 2: Determine the Applicable Regulatory Requirement Identify the appropriate License, registration, permission or approval required for the product and proposed activity.
3. Step 3: Identify Product Classification For medical devices and IVDs, determine the applicable risk classification where required.
4. Step 4: Prepare Required Documents Collect the necessary business, product, manufacturing, technical and quality-related documents.
5. Step 5: Create an Account on the Applicable Online Portal Many CDSCO regulatory services are processed through the SUGAM online portal, including relevant import registration and licensing services.
6. Step 6: Submit the Application Submit the application in the prescribed form along with the required documents and applicable fees.
7. Step 7: Regulatory Review The application may be reviewed by the relevant authority, and additional information or clarification may be requested where necessary.
8. Step 8: Inspection or Verification Depending on the product category and approval type, an inspection, audit or verification may be required.
9. Step 9: Grant of License or Approval Once all applicable requirements are fulfilled and the application is successfully verified, the concerned authority grants the registration, licence or approval. The certificate is then issued to the applicant and can be downloaded for official business use.

• PAN Card of the applicant or business
• GST Registration Certificate, where applicable
• Certificate of Incorporation or business registration documents
• Manufacturing License, where applicable
• Wholesale License, where applicable
• Product details and specifications
• Product labels and packaging details
• Product technical documents
• Manufacturing site details
• Quality management system documents
• Product test reports
• Free Sale Certificate or certificate from the country of origin, where applicable
• Authorization letter
• Details of the Indian authorized agent, where applicable
• Details of the manufacturing facility
• Other product-specific documents required under the applicable CDSCO framework