OPERON ELEVATEPLUS | CDSCO REGISTRATION IN INDIA
CDSCO Medical Device Registration for US Manufacturers Exporting to India
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
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 medical device registration, and do US manufacturers need it?
CDSCO (Central Drugs Standard Control Organisation) registration is the regulatory approval required to import, sell, or distribute medical devices in India. Any US manufacturer exporting devices to India — regardless of device class — must obtain either a registration certificate or an import license (MD-14/MD-15) before their product can legally enter the Indian market.
Does a US company need an Indian Authorized Agent for CDSCO registration?
Yes. Foreign manufacturers, including those based in the US, must appoint an Indian Authorized Agent to submit and manage the CDSCO import license application on their behalf, since applications are filed through India’s MD Online/NSWS portal.
How are medical devices classified under CDSCO?
CDSCO classifies medical devices into four risk-based categories — Class A (low risk) to Class D (high risk) — under the Medical Device Rules (MDR) 2017. The classification determines the registration pathway, required documentation, and approval timeline.
CDSCO classifies medical devices into four risk-based categories — Class A (low risk) to Class D (high risk) — under the Medical Device Rules (MDR) 2017. The classification determines the registration pathway, required documentation, and approval timeline.
Typical requirements include a Device Master File (DMF), Plant Master File (PMF), US FDA clearance/approval (if applicable), free sale certificate, ISO 13485 certification, and product technical documentation. Requirements vary by device class and product category.
Planning to Register, Import, or Manufacture Medical Devices in India
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