OPERON ELEVATEPLUS | CDSCO MEDICAL DEVICE REGISTRATION
CDSCO Medical Device and IVD Registration Consultant in India
Operon Strategist simplifies CDSCO medical device registration by offering end-to-end regulatory consulting under the Medical Devices Rules, 2017, covering registration, import licensing, and manufacturing licensing for medical devices and IVDs. Our structured approach ensures faster CDSCO approval, regulatory accuracy, and long-term compliance for medical device businesses.
Take the next step
Operon ElevatePlus CDSCO Medical Device Registration & Licensing Services in India
Our medical device registration India service covers six areas, from classification and dossier preparation to MD-14/MD-15 import licences and MD-5 (Class A and B) and MD-9 (Class C and D) manufacturing licences. We prepare and file MD CDSCO forms through CDSCO’s online portals: MD Online, NSWS, and the CDSCO SUGAM portal where it applies. For Indian manufacturers, our CDSCO medical device manufacturing license support runs from facility and QMS readiness to inspection and licence grant. Our guide explains the CDSCO registration process step by step.
CDSCO Medical Device Registration
Risk-based device classification (Class A–D)
Regulatory strategy under Medical Devices Rules, 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-7 / 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 Medical Devices Rules, 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 as a CDSCO Registration Consultant
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 import and manufacturing license approval for medical devices – 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.
As a CDSCO consultant India companies can rely on, Operon prepares and files your application and handles agency queries until approval. Foreign manufacturers file through an Indian Authorized Agent that holds a wholesale licence (Forms 20B and 21B/21C) and a power of attorney, so we also coordinate that set-up and handle SUGAM registration for the agent where needed. As a medical device regulatory consultant India-wide, we also support licensing, QMS readiness, and post-market compliance. Our guides cover the Medical Devices Rules, 2017, CDSCO classification, the CDSCO import licence, and licensing timelines. For other markets, see global product registration.
Operon CDSCO Approval Advantage
End-to-end regulatory support for CDSCO approval, 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
You Might Also Be Interested in
Frequently Asked Questions About Medical Device Registration India
What is CDSCO registration for medical devices and IVDs in India?
CDSCO registration is the regulatory process for obtaining the required approvals and licenses to manufacture, import, or market applicable medical devices and in vitro diagnostic (IVD) products in India under the country’s medical device regulatory framework. CDSCO medical device registration covers two main routes: an import licence (Forms MD-14 and MD-15) and a manufacturing licence (MD-5 for Class A and B, MD-9 for Class C and D).
How can a CDSCO medical device and IVD registration consultant help?
A CDSCO registration consultant can assist with product classification, regulatory pathway assessment, documentation, application preparation, licensing requirements, and regulatory submissions to help manufacturers and importers comply with applicable CDSCO requirements.
Which medical devices and IVDs require CDSCO registration in India?
Medical device registration India applies to medical devices and IVDs placed on the Indian market, which are regulated under the Medical Devices Rules, 2017. The route depends on the product type, classification, and whether it is manufactured in India (manufacturing licence) or imported (import licence through an Indian Authorized Agent).
How are medical devices classified for CDSCO registration in India?
CDSCO classification sorts medical devices by risk level into Class A, B, C, and D, with different regulatory requirements for each class. The classification helps determine the licensing authority and pathway: the State Licensing Authority for Class A and B manufacturing, and the Central Licensing Authority for Class C and D manufacturing and for imports.
How long does CDSCO medical device registration take?
Planning to Register, Import, or Manufacture Medical Devices in India
Talk to a CDSCO registration consultant