OPERON ELEVATEPLUS | CDSCO REGISTRATION IN INDIA
CDSCO Registration for Medical Devices Entering the Indian Market
Operon Strategist simplifies CDSCO compliance by offering end-to-end regulatory consulting — covering registration, import licensing, and manufacturing licensing. Our structured approach ensures faster approvals, regulatory accuracy, and long-term compliance for medical device businesses across India.
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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
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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frequently asked questions
What is CDSCO and why is it relevant to medical devices in India?
CDSCO (Central Drugs Standard Control Organisation) is India’s national regulatory authority for medical devices, responsible for registration, import licensing, and manufacturing licensing under the Medical Device Rules (MDR) 2017.
How are medical devices classified under Indian MDR 2017?
Devices are classified into risk-based classes A, B, C, and D, with Class A being lowest risk and Class D being highest risk, determining the applicable licensing pathway and level of regulatory scrutiny.
What is the difference between a CDSCO import license and a manufacturing license?
An import license (MD-14/MD-15) is required for foreign manufacturers or their authorized agents to import devices into India, while a manufacturing license (MD-3/MD-5/MD-9) is required for companies producing medical devices within India.
What is CDSCO registration for medical devices in India?
CDSCO registration is the regulatory process for meeting the applicable requirements of the Central Drugs Standard Control Organisation (CDSCO) to manufacture, import, or market medical devices in India.
Planning to Register, Import, or Manufacture Medical Devices in India
Get expert CDSCO regulatory guidance