OPERON ELEVATEPLUS | CDSCO REGISTRATION IN INDIA

CDSCO Medical Devices Registration & Licensing Services for Brazil

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 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

CDSCO medical devices registration refers to the regulatory process required for applicable medical devices to be legally manufactured, imported, or marketed in India. The applicable pathway depends on the device classification, intended use, risk level, and whether the device is manufactured in India or imported. Medical devices are regulated under the Medical Devices Rules, 2017.

Medical device manufacturers and importers must follow the applicable CDSCO regulatory pathway before placing regulated medical devices on the Indian market. The requirements depend on the device classification and whether the product is manufactured domestically or imported

Yes. Brazilian manufacturers planning to export medical devices to India must meet the applicable CDSCO requirements for imported medical devices. Depending on the device and regulatory pathway, the manufacturer may need to appoint an authorised representative in India and submit the required regulatory documentation.

Medical devices are generally classified into four risk categories:

Class A: Low risk
Class B: Low-to-moderate risk
Class C: Moderate-to-high risk
Class D: High risk

The classification affects the applicable licensing authority, regulatory pathway, documentation requirements, and level of regulatory review

The documentation requirements depend on the device type and regulatory pathway. Common documents may include device information, intended use, classification details, technical documentation, manufacturing information, quality management system evidence, risk management documentation, clinical or performance evidence, labelling, Instructions for Use, and applicable certificates from the country of origin.

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

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