Medical Device Regulatory Solutions for Importers in India
Foreign medical device manufacturers seeking market authorization in India require an independent Authorized Indian Representative (AIR), meticulous Device Master File compilation, and online SUGAM submission to obtain CDSCO Form MD-15 import licenses.
5-Stage Medical Device Import Authorization Process
Device Classification & Predicate Review
Identify whether your device falls into Class A, B, C, or D under MDR 2017 and establish substantial equivalence with CDSCO notified predicate devices.
Appointment of Authorized Indian Representative (AIR)
Execute Power of Attorney (PoA) and Form 9 appointing NKB Regovanta as your in-country legal representative holding valid wholesale Form 20B/21B licenses.
Dossier Compilation (Plant Master File & Device Master File)
Compile ISO 13485 QMS certificates, Free Sale Certificates (FSC) from reference countries, clinical evaluation reports, risk management files, and bilingual labeling.
SUGAM Portal Submission & MD-14 Filing
Digital submission through CDSCO's SUGAM portal, statutory treasury challan fee remittance, and active liaison during technical scrutiny.
Grant of Import License (Form MD-15)
CDSCO Central Licensing Authority grants the perpetual import license, enabling seamless customs clearance and nationwide distribution.
Independent AIR Model
Retain full ownership of your Indian regulatory licenses without giving commercial distribution exclusivity to single local distributors.
Full Dossier Compilation
We structure your technical files, CE MDR / FDA 510(k) evidence, risk management files, and ISO 13485 QMS into CDSCO formats.
Post-Market Vigilance
Continuous compliance with Materiovigilance Programme of India (MvPI), managing adverse event reporting and periodic safety update reports.
Consult Our Medical Device Importer Desk
Get an initial regulatory classification review, fee roadmap, and timeline estimate for your medical device import.