CDSCO Registration Consultant in India
Expert CDSCO registration support for medical devices, drugs, IVDs, and cosmetics. DK Reg Compliance handles classification, SUGAM filing, and query responses — free assessment call.
- Fast-track application drafting & authority liaisoning
- Guaranteed compliance with CDSCO/FSSAI/State guidelines
- 100% turnkey documentation support from start to approval
Connect with our senior regulatory experts in 15 mins.
What Is CDSCO and When Do You Need Registration?
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority for drugs, medical devices, in-vitro diagnostics (IVDs), and cosmetics, operating under the Directorate General of Health Services, Ministry of Health and Family Welfare.
CDSCO registration is mandatory for:
- Importing drugs, cosmetics, or medical devices into India
- Manufacturing new drugs or fixed-dose combinations
- Registering Class C and D medical devices
- Online pharmaceutical platforms
- Foreign manufacturers seeking Indian market access
CDSCO Services DK Reg Handles
Drug Registration
New drug approvals, subsequent new drug applications, and fixed-dose combination (FDC) approvals through the SUGAM portal.
Medical Device Registration
Class C and D device registration, MD-14/MD-15 import licenses, IVD registration, and Class A NSNM self-notification.
Cosmetic Registration
Import registration for cosmetic products under the Drugs and Cosmetics Act (Form CDSCO-Cosm-1).
Indian Authorised Agent (IAA)
Foreign manufacturers must appoint an Indian Authorised Agent before filing with CDSCO. DK Reg acts as IAA or supports IAA appointment.
CDSCO Registration Process (SUGAM Portal)
- Product classification determination (drug / device / cosmetic / IVD)
- License type and fee determination
- Digital signature (DSC) setup for SUGAM portal
- Dossier / Device Master File (DMF) / Plant Master File (PMF) preparation
- SUGAM portal filing
- Query and deficiency response management (30-day CDSCO deadline)
- License / Registration Certificate issuance
Why CDSCO Query Response Is Critical
CDSCO allows a 30-day window to respond to deficiency notices. Missed deadlines result in automatic application closure, losing the filing fees paid. DK Reg monitors all active applications and responds within 48 hours of query receipt — protecting both timeline and investment.
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Other Services
Get your drug license for retail, wholesale, or manufacturing with DK Reg Compliance — India’s trusted drug license consultant. Expert guidance, fast approvals, pan-India service.
Get your wholesale drug license for pharmaceutical distribution — stockists, C&F agents, and distributors. DK Reg Compliance handles documentation, state FDA submissions, and approvals.
Open your pharmacy legally with a retail drug license. DK Reg Compliance handles Form 20 & 21 applications, pharmacist documentation, state FDA submissions, and fast approvals.
Get your drug manufacturing license for tablets, capsules, injectables, or Ayurvedic formulations. DK Reg Compliance handles GMP compliance, Form 25 filing, and state FDA coordination.
Medical device registration in India — Class A, B, C, D classification, CDSCO filing, MD-14/MD-15 import licenses, and IVD registration. Expert support from DK Reg Compliance.
Get your medical device import license (MD-14/MD-15) from CDSCO. DK Reg Compliance prepares Device Master Files, Plant Master Files, and manages full SUGAM submission.
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