CDSCO vs FDA: Key Differences Between Indian and US Medical Regulatory

For medical device manufacturers, pharmaceutical companies & importers, understanding regulatory requirements in different countries is essential. Two of the most important global agencies are India’s Central Drugs Standard Control Organization (CDSCO) and the United States Food and Drug Administration (FDA). Both bodies oversee safety, efficacy & quality compliance, but they differ in scope, classification, submission protocols & enforcement.

What is CDSCO Registration?

CDSCO Registration is the process of registering medical devices, drugs, and cosmetics with the Central Drugs Standard Control Organization under India’s Ministry of Health & Family Welfare. It is mandatory for manufacturers and importers planning to market notified products in India.

CDSCO issues licenses for:

• Class A to D medical devices

• Notified drugs & vaccines

• In-vitro diagnostic kits

• Cosmetic formulations

All foreign manufacturers must appoint an Indian Authorized Agent to obtain CDSCO Certification.

What is FDA Approval?

The US Food and Drug Administration (FDA) regulates food, pharmaceuticals, biologics, medical devices & radiation-emitting products. FDA approval is required to commercialize regulated items in the US market.

FDA approval may involve:

• Pre-market Notification [510(k)]

• Pre-market Approval (PMA)

• De Novo Classification

• Drug Master File (DMF) submission

Unlike CDSCO Registration, FDA has a more extensive post-market surveillance & audit mechanism.

Key Steps in CDSCO Registration

1. Identify product classification (Class A, B, C, or D)

2. Appoint an Indian Authorized Representative (for foreign entities)

3. Prepare technical documents including Device Master File (DMF)

4. Apply online via CDSCO Sugam Portal

5. Submit fees, samples (if needed), and follow-up queries

6. Obtain Import License or Manufacturing License

Om Garuda Group assists manufacturers at every step of the CDSCO Registration process, including classification mapping & compliance documentation.

Key Steps in FDA Approval

1. Determine device classification (Class I, II, III)

2. Submit 510(k), PMA or De Novo request

3. Prepare Clinical Evaluation Reports & bench testing results

4. Register Establishment & list device on FDA portal

5. Respond to Information Requests (IRs)

6. Receive clearance or approval

FDA does not issue a physical certificate but provides electronic documentation of authorization.

Technical File Requirements: CDSCO vs FDA

Both agencies require:

• Product specifications & schematics

• Risk analysis (ISO 14971)

• Biocompatibility & clinical data

• Labelling compliance

Differences:

• CDSCO Certification mandates Indian market labeling, importer declaration, and local warehouse info

• FDA focuses on Unique Device Identifier (UDI), post-market monitoring & Good Manufacturing Practices (GMP)

Audit & Inspection

• CDSCO Registration does not always involve plant inspections, especially for low-risk Class A devices

• FDA routinely audits manufacturing facilities under 21 CFR Part 820 (QSR)

Om Garuda Group helps companies prepare for site audits & respond to non-conformance observations in both regimes.

Post-Market Surveillance

• CDSCO requires submission of Periodic Safety Update Reports (PSUR) & adverse event logs

• FDA mandates Medical Device Reporting (MDR), Field Safety Notices & CAPA documentation

Both systems enforce recalls, penalties & legal action in case of public safety violations.

Certification Validity & Renewal

• CDSCO Certification is valid for 3 years; renewal must be initiated 6 months before expiry

• FDA approvals do not expire but require annual establishment registration & listing renewals

Lapses in either system can block imports, distribution & trigger compliance enforcement.

Why Choose Om Garuda Group for CDSCO Registration?

• Dedicated regulatory experts for Indian & US markets

• CDSCO document drafting, portal filing & query handling

• Importer identification & license holding support

• BIS, WPC, EPR & cross-certification compliance

• Post-approval compliance maintenance & audit assistance

We ensure your CDSCO Registration efforts are error-free, timeline-aligned & audit-compliant.

CDSCO Registration is not a substitute for FDA approval, and vice versa. Each system has unique regulatory pathways, approval formats, and compliance expectations. Businesses planning global distribution must be prepared for parallel regulatory submissions.

Om Garuda Group bridges the compliance gap between Indian & US regulatory systems — helping you achieve both CDSCO Certification and FDA clearance through structured planning, expert document preparation & real-time submission support.