CDSCO Medical Device Regulatory Services

CDSCO regulatory support for medical devices in India including registration and clinical requirements.

CDSCO Regulatory Support for Medical Devices

Bioexcel supports manufacturers with India medical device regulatory requirements under CDSCO, ensuring compliant submissions and approvals.

India CDSCO Regulatory Strategy & Market Authorization
Strategic regulatory planning and end-to-end licensing support under the Medical Devices Rules (MDR), 2017.
From classification to license grant — structured for compliant, defensible, and audit-ready submissions.

Our approach integrates device classification, documentation architecture, clinical evidence alignment, and regulatory query management — ensuring structured submissions under the Medical Devices Rules, 2017.

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Regulatory Query & Review Management

Bioexcel supports domestic and international manufacturers in securing market authorization in India under CDSCO.

Regulatory Query & Review Management

CDSCO query response strategy

Technical deficiency resolution

Coordination with Subject Expert Committees (SEC)

Pre-submission advisory support

Lifecycle compliance & post-approval change management

REGULATORY FRAMEWORK ALIGNMENT

Our submissions align with:

Medical Devices Rules (MDR), 2017

CDSCO guidance documents

BIS standards where applicable

Indian Pharmacopoeia (for IVDs where relevant)

GCP guidelines (India)

Schedule M III (Quality Management Systems)

We structure documentation anticipating CDSCO technical review expectations.

Beyond Licensing Support

We design India regulatory submissions with:

Structured technical documentation architecture

Clinical evidence defensibility

Import strategy optimization

Pre-emptive deficiency mitigation

Integrated global evidence leverage (EU / FDA to India alignment)

Our objective: reduce approval delays and strengthen regulatory defensibility in India.

Capabilities

Capabilities – Device classification (India) – Registration & import license support – Clinical evidence review -Regulatory query responses

India Regulatory Capabilities
Regulatory Pathway & Classification

Device classification (Class A, B, C, D)
Predicate assessment & intended use positioning
Regulatory pathway mapping (Import / Manufacturing / Loan License)
Determination of clinical investigation requirements
Risk-based strategy planning

Plan Your CDSCO Submission

Licensing & Registration Support

Import License (Form MD-14 / MD-15)
Manufacturing License (Form MD-7 / MD-9)
Registration for Notified Devices
Authorized Indian Agent support
Site documentation & Plant Master File review
Device Master File (DMF) structuring

Clinical & Technical Documentation

Clinical evidence review & justification
Bridging study strategy (if required)
Performance evaluation alignment
Essential Principles / Safety & Performance compliance
Risk management documentation alignment (ISO 14971)
IFU & labeling review per India MDR

Frequently Asked Questions (FAQ)

Does Bioexcel guarantee regulatory approval?Bioexcelife2026-02-10T09:22:59+00:00

Does Bioexcel guarantee regulatory approval?

No. Bioexcel supports compliant preparation and strategy; final approval decisions rest with regulatory
authorities.

Can the same clinical evidence be used across regions?Bioexcelife2026-02-10T09:24:10+00:00

Can the same clinical evidence be used across regions?

Often yes, with region-specific adaptations based on regulatory requirements.