CDSCO MDR Approval

Streamlining CDSCO MDR Approval for Medical Devices in India

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info About this service

What is CDSCO MDR Approval?

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route Process

How We Work

1

Device Classification Assessment

We classify your device (Class A–D) per Rule 19 of MDR 2017, tailoring the approval strategy.

2

Comprehensive Document Compilation

We prepare Device Master File (DMF), Plant Master File (PMF) and technical dossiers, per CDSCO guidelines.

3

Online Application Submission

We file your application on the CDSCO portal, ensuring accuracy and timely submission.

4

Regulatory Liaison Management

We handle CDSCO queries and coordinate inspections (if required), expediting approvals.

5

Application Status Monitoring

We track progress, resolve issues and keep you informed until approval is granted.

6

Approval with Optional Paid Support

We deliver your CDSCO certificate, with optional paid support for renewals or compliance, billed separately as an add-on service.

checklist Prerequisites

Information Required

Comprehensive preparation of Device Master File (DMF), Plant Master File (PMF), and technical dossiers.
Seamless filing of your application on the CDSCO portal, ensuring accuracy and timeliness.
Expert handling of all communications, queries, and coordination with CDSCO on your behalf.
Continuous tracking of your application status and proactive issue resolution until approval.

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Key Benefits

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What You Receive

map Detailed Regulatory Roadmap — A customized step-by-step plan outlining the CDSCO approval process tailored to your specific medical device and business needs.
description Complete Application Dossier — Preparation and submission of a full, CDSCO-compliant application dossier including Device Master File (DMF), Plant Master File (PMF) and all technical documents.
web_asset Online Application Filing — Handling of the entire online application process on the CDSCO portal, ensuring accurate and timely submission without client hassle.
handshake Liaison & Communication Management — Acting as your official liaison with CDSCO, managing all correspondence, clarifications and responses to regulator queries on your behalf.
quiz FAQ

Frequently Asked Questions

A regulatory certification under MDR 2017 for medical devices to ensure safety and quality for sale in India.
It ensures legal compliance, patient safety and market access for medical devices, per Drugs and Cosmetics Act, 1940.
All notified medical devices (Class A–D), including diagnostics, implants and surgical tools, per MDR 2017.
Manufacturers and importers of notified medical devices, per Rule 20 of MDR 2017.
Non-compliance may lead to fines or bans under Section 27 of the Drugs and Cosmetics Act, 1940.
30–60 days for Class A/B (non-regulatory), 90–120 days for Class C/D, depending on complexity, per CDSCO processes.
Mandatory for Class C/D and some Class A/B if novel; predicate device data may suffice, per Rule 21.
Yes, with an Authorized Indian Agent to liaise with CDSCO, per Rule 20 of MDR 2017.
DMF, PMF, ISO 13485 certificate, clinical data (if applicable) and labeling details, per CDSCO guidelines.
We provide end-to-end support, from classification to certification, ensuring compliance and speed.
Five years, renewable with compliance audits, per MDR 2017, Rule 29.
No, support for renewals or compliance is an optional paid service, billed separately.
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