Medical Device Manufacturing & Loan Licensing in India
Establish world-class medical device manufacturing facilities in India with full regulatory compliance under Medical Device Rules, 2017. We guide manufacturers through State FDA (Form MD-5) and Central CDSCO (Form MD-9) licensing.
5-Stage Medical Device Manufacturing Authorization Pathway
Manufacturing Site Layout & Architectural Validation
Design plant architecture, cleanroom zoning (ISO Class 7/8), HVAC air handling systems, and water treatment loops compliant with Schedule M-III and ISO 13485.
QMS Implementation (ISO 13485:2016 & MDR 2017)
Develop Standard Operating Procedures (SOPs), Quality Manuals, Design Controls, and Risk Management frameworks (ISO 14971).
Test License Application (Form MD-12)
Obtain statutory test license from CDSCO/SLA for batch trial production, equipment qualification (IQ/OQ/PQ), and prototype testing.
Commercial Manufacturing Application Filing (MD-3 / MD-7)
Submit Plant Master File (PMF) and Device Master File (DMF) on SUGAM to State FDA (Class A/B) or Central CDSCO (Class C/D).
Statutory Inspection & License Grant (MD-5 / MD-9)
Coordinate Notified Body and Drug Inspector on-site audits to resolve observations and secure the commercial manufacturing license.
State FDA vs CLA Direct
Complete support for Class A & B devices with State Drug Authorities, and Class C & D devices with CDSCO New Delhi.
ISO 13485 QMS Alignment
Preparation of full quality manual, DMR, DHF, CAPA workflows, and supplier audit criteria for Notified Body audit readiness.
Loan Licensing (MD-6 / MD-10)
Manufacture your branded medical devices using existing licensed contract manufacturing facilities across India.
Speak with Our Manufacturing Regulatory Team
Connect with our senior technical consultants for plant audit readiness, dossier drafting, and license grant.