CDSCO Licence (Drug & Medical Device)

LICENCE/CERTIFICATION

The Central Drugs Standard Control Organisation (CDSCO), functioning under the Ministry of Health & Family Welfare, is India's apex regulatory authority for drugs, cosmetics, diagnostics, and medical devices. Cosmetics imported into India require registration with the Central Licensing Authority under the Drugs and Cosmetics Act 1940 and the Cosmetics Rules 2020.Import licence applications are submitted through the Sugam online portal using Form COS-1, while domestic manufacturers apply using Form COS-5. CDSCO evaluates the application, issues Form 42 as the registration acknowledgement, and then conducts a detailed review. Manufacturer applicants (as opposed to importers) may be subject to a premises inspection before the licence is granted.Fee Schedule for Import RegistrationPer product category: USD 1,000Per manufacturing site: USD 500Per product variant: USD 50The cosmetics import registration is valid for five years and is renewable. Separate registrations are required for each distinct product category.Documents RequiredCertificate of Free Sale from the country of originGMP compliance certificate from the manufacturerProduct composition and safety assessment dataIndian-market compliant product labellingPower of attorney for the Indian authorised agent

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Our Process

Free Consultation

Our certification experts assess your product or system and determine the exact scope of certification required.

Gap Analysis & Documentation

We perform a thorough gap analysis against the applicable standard and prepare all required technical documentation.

Audit / Testing Coordination

We coordinate with accredited testing labs or CB auditors to schedule product testing or management system audits.

Application Submission

We compile and submit the complete application to the relevant certification body (BIS, TUV, SGS, etc.) on your behalf.

Authority Follow-up

We actively follow up with the authority to resolve queries, provide clarifications, and track application progress.

Certificate Issuance

Once approved, the certificate is issued and delivered. We also support surveillance audits and renewal cycles.

Documents Required

The following documents are generally required. Exact requirements may vary based on your product, entity type, and applicable standard. Our team provides a precise checklist after consultation.

Company Registration Certificate (GST / Incorporation)

Product brochure / technical specifications

Testing reports from accredited laboratories

Quality manual and relevant SOPs (for management systems)

Factory layout and process flow diagrams (for product certifications)

Authorisation letter appointing FGMS as consultant

Previous audit reports / certificates (if any)

Frequently Asked Questions

The timeline depends on document completeness and authority workload. Typically processes range from 4–16 weeks. Our team provides a specific timeline during consultation based on your product and category.

Fees vary based on product category, scope, number of models, and applicable standard. We offer competitive professional fees with complete transparency — no hidden charges. Contact us for a detailed quote.

Yes. FGMS offers a fully managed end-to-end service. We handle documentation, application submission, testing coordination, and follow-up — you only need to provide the required information and documents.

Whether mandatory or voluntary depends on the product category and applicable Quality Control Orders. We advise clients on regulatory obligations and help achieve compliance before product launch.

Our experience greatly reduces rejection risk. However, if queries are raised, we handle all correspondence and provide the required clarifications to the relevant authority promptly.

Why Choose FGMS?

15+ Years Experience

Deep domain expertise spanning BIS, ISO, WPC, EPR, and 50+ certification schemes

Pan-India & Global Reach

Offices across India and liaison in 50+ countries for overseas market certifications

Fast Turnaround

Dedicated case managers accelerate every step to save you critical market time

Transparent Pricing

Fixed professional fees with no hidden costs — clear cost breakdowns from day one

Expert Team

Chartered engineers, legal experts, and ex-government consultants on your case

High Success Rate

99%+ certification success record built on thorough preparation and rigorous quality checks

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Accreditations

BIS Approved Consultant

ISO 17021 Compliant Process

MoMSME Registered

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D&B Verified Company

CDSCO Licence (Drug & Medical Device)