OPERON ELEVATEPLUS | CDSCO MEDICAL DEVICE REGISTRATION

CDSCO Medical Device and IVD Registration Consultant in 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.

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Operon ElevatePlus
CDSCO Registration for Medical Devices in India

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

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

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

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

CDSCO liaison and regulatory correspondence

Response to deficiency letters & portal queries

Guidance on post-market surveillance requirements

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 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.

Operon CDSCO Registration 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

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.

A CDSCO 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.

Medical devices and IVDs placed on the Indian market are regulated under the applicable Indian medical device regulations, with requirements depending on the product type, classification, and whether it is manufactured or imported.

Medical devices are classified according to their risk level, with different regulatory requirements applying to different classes. The classification helps determine the applicable licensing and approval pathway.

The timeline varies depending on the device or IVD classification, type of application, completeness of documentation, testing requirements, and the applicable regulatory approval pathway.

 
 
 

Planning to Register, Import, or Manufacture Medical Devices in India

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