OPERON ELEVATEPLUS | CDSCO REGISTRATION IN INDIA
CDSCO Medical Device Registration & Licensing Services in Oman
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Operon ElevatePlus
CDSCO Registration for Medical Devices in India
CDSCO Medical Device Registration
Risk-based device classification (Class A–D)
Regulatory strategy under Medical Device Rules (MDR) 2017
Dossier & technical documentation preparation
Online submission via MD Online / NSWS portal
CDSCO query handling & approval support
CDSCO Import License for Medical Devices (MD-14 / MD-15)
Eligibility assessment for foreign manufacturers & Indian authorized agents
Device classification & import pathway evaluation
Preparation of Device Master File (DMF) & Plant Master File (PMF)
Submission of import license applications on CDSCO portal
Coordination with CDSCO for queries, clarifications & approvals
Post-approval support for license validity, amendments & renewals
CDSCO Manufacturing License for Medical Devices (MD-3 / MD-5 / MD-9)
Licensing strategy for Indian manufacturers (Class A–D)
Facility & QMS readiness assessment
Preparation of technical files, SOPs & compliance documentation
Support for State Licensing Authority & CDSCO inspections
Audit preparation and deficiency closure
License grant, renewal & variation support
CDSCO Registration for Software as a Medical Device (SaMD)
SaMD classification as per CDSCO guidelines and MDR 2017
Regulatory strategy for standalone software & software-driven devices
Preparation of SaMD technical documentation, including intended use & risk classification
Clinical evaluation, performance validation & cybersecurity documentation support
Submission through CDSCO / NSWS portal
Regulatory query handling and approval follow-up
Regulatory Communication & Compliance Support
CDSCO liaison and regulatory correspondence
Response to deficiency letters & portal queries
Guidance on post-market surveillance requirements
Post-Approval & Lifecycle Support
License renewals & amendments
Product additions & change management
Ongoing regulatory compliance support
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
200+ CDSCO Registrations & Licenses Completed
12+ Years of CDSCO Regulatory Experience
Expertise Across Class A, B, C & D Devices
Clients Supported Across 30+ Countries
CDSCO medical device import and manufacturing license approval for – we support manufacturers in securing CDSCO approvals through a structured regulatory and licensing strategy. Our services include device classification, regulatory pathway planning, and execution of both import and manufacturing license applications. With strong documentation and regulatory alignment, we help achieve timely approvals with minimal observations, enabling compliant market entry and launch in India.
Operon CDSCO Regitstration Advantage
End-to-end regulatory support for CDSCO registration, import licensing, and manufacturing licensing helping medical device companies enter and operate in the Indian market with full compliance
Complete CDSCO Regulatory Lifecycle Support
Expertise in MD Online & NSWS Portals
Strong Query-Handling & Approval Success Rate
In-House Regulatory & Technical Documentation Team
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Planning to Register, Import, or Manufacture Medical Devices in India
Get expert CDSCO regulatory guidance