Demystifying Medical Device Rules (IMDR, 2017) — The Right Way

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Understanding CDSCO Licensing

Class A

Low-Moderate Risk

High Risk

Low Risk

Moderate-High Risk

Class C

Class D

Class B

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Risk-based Device Classification

Our role is to simplify this process — guiding you through classification, documentation, testing requirements, and regulatory submissions — ensuring your device meets all applicable regulatory expectations without delays.

In India, all medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017 (IMDR 2017).

Depending on the risk class and whether the product is for domestic manufacturing or import, new device or existing device, manufacturers must obtain appropriate CDSCO licenses.

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How We Can Help?

We offer structured, hands-on support across every stage of the licensing journey.

Gap Assessment & Readiness Check

Review existing QMS, technical documents, and testing status
Assess compliance with IMDR 2017 and CDSCO requirements
Identify gaps in processes, files, or infrastructure
Recommend corrective actions and timelines
Provide a structured roadmap to licensing

QMS & Technical Documentation Support

Prepare or upgrade Device Master File (DMF) & Plant Master File (PMF)
Develop risk management files as per ISO 14971
Draft Instructions for Use (IFU), labels
Compile declarations, undertakings, and product info
Align all documentation to Fifth Schedule and form-specific needs

Determine correct risk class (A, B, C, or D) under IMDR 2017
Recommend suitable regulatory route: manufacture, import, test, etc.
Advise on correct CDSCO forms and submission routes
Clarify requirements based on class and device type
Guide on transition from voluntary registration, if applicable

Device Classification & Regulatory Strategy

Identify relevant test types: performance, biocompatibility, electrical, etc.
Recommend types of labs (NABL-accredited, notified) based on requirements
Provide documentation for lab submission (sample info, formats, etc.)
Review test protocols and integrate test results into the technical file

Type Testing & Lab Coordination

CDSCO Forms & Online Submission Support

Identify correct application forms based on use case
Compile and format documents as per form-specific checklists
Provide portal-ready versions of annexures and declarations
Guide you through the Sugam/NSWS portal submission steps
Support in responding to document-related queries (if any)

Audit Preparation & Post-Approval Documentation

Organize technical files and QMS records for audit readiness
Provide document checklists based on device class and form
Support preparation for document-based reviews or inspections
Assist in updating documentation after design, label, or site changes
Prepare forms and annexures for post-approval amendments

Key Deliverables

Device Master File (DMF) and Plant Master File (PMF)
Clinical Evaluation/Evidence Report, if applicable
Risk Management File (RMF)
Instructions for Use (IFU) and Labelling Documentation support
QMS Documentation Support (as per IMDR 2017, Fifth Schedule)
Essential Principles Checklist
Declarations and Undertakings
NABL accredited Test lab assistance

End-to-end Compliance Support

Audit-Ready Technical Documentation

Notified Body Approval Support

Post-market Surveillance setup

Ongoing Regulatory Support

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Who We Help?

First-Time Applicants

Manufacturers Without In-House Regulatory Teams

Whether you're a Startup, SME, or an established manufacturer, we tailor our support to meet your specific product, process, and team needs.

OEMs & Contract Manufacturer

Companies applying for government tenders or GEM portal listings

Startups & Innovation-Driven Enterprises

Exporters & Importers Requiring CDSCO Compliance

Ready for CDSCO Approval?

Let’s talk about your device, timelines, and goals. Whether you're just beginning or need support for a specific module—risk, CER, PMS—we’re here to help

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Our Workflow

1

Understand Your Product & Goals

Map the Regulatory Pathway

Support You Beyond Approval

Execute with Precision

Communicate Transparently

Maintain Ethics & Confidentiality

2

3

6

5

4

Why Choose VIDHA?

Expertise You Can Trust

Hands-on experience, backed by a strong understanding of global and Indian regulatory frameworks.

Personalized Solutions

We tailor every document, process, and support plan to your specific device class, regulatory pathway, and business goals.

Reliable & Confidential Support

We prioritize confidentiality, integrity, and compliance — ensuring your data and submissions are handled with care and professionalism.

Our services are focused, efficient, and aligned with your timelines and budgets.

Timely & Cost-Effective Delivery

Frequently asked questions

Is ISO 13485 certification mandatory to apply for a CDSCO license?

No, it is not mandatory. CDSCO does not require ISO 13485 certification to obtain a manufacturing or import license under IMDR 2017. However, your Quality Management System must meet the requirements outlined in Schedule V of the Medical Device Rules. Having ISO 13485 can strengthen your application and ease future global approvals, but it’s not a prerequisite for CDSCO license.

What is the validity period of a CDSCO manufacturing or import license?

CDSCO licenses issued under IMDR 2017 (such as MD‑5, MD‑9, MD‑15) are valid indefinitely. However, licensees must pay a retention fee every five years. If the fee is not paid — even within the extended 180-day grace period — the license is automatically cancelled.

Can CDSCO accept foreign clinical data or test reports?

Yes, CDSCO may accept foreign clinical data or test reports, especially when generated from recognized, accredited labs. However, the acceptability depends on the device class and intended use. We help assess whether your existing international data is sufficient or if additional testing is needed for India.

What happens if I update my device design after getting CDSCO approval?

You may need to file an endorsement seeking post-approval change with updated documents. We can help assess whether the change is major or minor and prepare the necessary amendment documentation accordingly.

FAQs

Still got Questions? Let's talk!