CDSCO INDIA

CDSCO INDIA

End-to-end regulatory approval — CDSCO, ICMR, NDHM, NABL. From docs to audits, we ensure full Indian compliance.

Test License (MD-13)
Import Test License (MD-17)
Clinical Investigation Permission (MD-23)
Manufacturing Licenses (MD-5 & MD-9)
Loan License (MD-10)
Import License (MD-15)
Wholesale License (MD-42)
Device Master File (DMF) construction
Plant Master File (PMF) construction
Risk Assessment of product (ISO 14971)
Usability Study (IEC 62366) assistance
Regulatory Risk Classification

Authorized Representative (AR) Service
MD online and NSWS account creation
Post Approval Change (PAC) submission
IEC 62304 (SDLC) documentation
MvPI (Materiovigilance program of India)
NPPA/DPCO communication and resolution
UCMPMD (Uniform Code for Marketing Practices in Medical Devices)
Free Sale Certificate (FSC)
Non-Conviction Certificate (NCC)
Market Standing Certificate (MSC)
NSQ (Not of Standard Quality) Resolution
FSCA (Field Safety Corrective Action) support

Services