CDSCO Registration Consultant in India — SUGAM Portal Experts
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority for drugs, medical devices, in-vitro diagnostics (IVDs), and cosmetics under the Ministry of Health and Family Welfare. CDSCO registration is mandatory for importing medical products into India, manufacturing new drugs or fixed-dose combinations, registering Class C/D medical devices, and establishing foreign manufacturer Indian Authorised Agency (IAA). DK Reg Compliance manages complete SUGAM portal filings, Device Master Files, and 30-day query turnarounds.
- Foreign medical device and drug manufacturers seeking import access into the Indian market
- Indian importers and distributors applying for MD-14 / MD-15 import registrations
- Domestic manufacturers of Class C and Class D medical devices requiring CDSCO Central Licensing approval
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Overview & Local Scope
Fast-Track CDSCO Registration Consultant in India | Drugs, Devices & Cosmetics in Mumbai
The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority for drugs, medical devices, in-vitro diagnostics (IVDs), and cosmetics under the Ministry of Health and Family Welfare. CDSCO registration is mandatory for importing medical products into India, manufacturing new drugs or fixed-dose combinations, registering Class C/D medical devices, and establishing foreign manufacturer Indian Authorised Agency (IAA). DK Reg Compliance manages complete SUGAM portal filings, Device Master Files, and 30-day query turnarounds.
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Contact UsForeign medical device and drug manufacturers seeking import access into the Indian market
Indian importers and distributors applying for MD-14 / MD-15 import registrations
Domestic manufacturers of Class C and Class D medical devices requiring CDSCO Central Licensing approval
Pharmaceutical companies applying for new drug approvals, clinical trials, or FDC permissions
Cosmetic brand owners and importers applying for Form CDSCO-Cosm-1 registration certificates
Step-by-step process
How our Mumbai registration works
Regulatory Pathway & Classification Determination: We analyze your product formulation or technical characteristics to determine exact CDSCO risk class (A, B, C, D or drug category).
Indian Authorised Agent (IAA) Setup: For foreign manufacturers, we act as or coordinate power of attorney with a licensed Indian Authorised Agent.
SUGAM Portal Setup & Digital Signature: We register your corporate profile on SUGAM using Class 3 Digital Signatures (DSC).
Dossier / Master File Preparation: We compile Plant Master Files (PMF), Device Master Files (DMF), Free Sale Certificates (FSC), and ISO 13485 proofs.
Submission & 30-Day Query Defense: We monitor SUGAM tracking daily and defend technical queries within CDSCO's mandatory 30-day window until registration grant.
Documents required
Filing checklist for Mumbai
- Power of Attorney (POA) from foreign manufacturer executed in favor of Indian Authorised Agent
- Free Sale Certificate (FSC) / Certificate to Foreign Government (CFG) issued by national health authority
- ISO 13485:2016 quality management system certification of the manufacturing facility
- Device Master File (DMF) / Site Master File containing design specifications and risk analysis
- Plant Master File (PMF) detailing manufacturing cleanrooms, sterilization, and QC methods
- Biocompatibility test reports, clinical evaluation reports, and stability data
- Copy of valid wholesale drug/device license of the Indian importer/applicant
Verified Support in Mumbai
Whether you are located in the business center of Mumbai or surrounding industrial corridors, our consultants manage state and zonal submissions directly.
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