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Hisho & Kanri
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Medical Device Registration

Bring your medical device to market, compliantly and on schedule.

Medical Device Registration is the regulatory process of licensing a device with the Central Drugs Standard Control Organisation (CDSCO) under the Medical Device Rules, 2017 — before it can be manufactured, imported, sold, or distributed in the country. Every device is classified by risk (Class A, B, C, or D), and the registration route, documentation, and scrutiny depend entirely on where your product falls.

Done right, it gives your device legal market access, hospital-procurement eligibility, and buyer confidence. Done late or incorrectly, it can mean import holds, product recalls, or a blocked launch — which is why most manufacturers and importers bring in a regulatory specialist to manage classification, testing evidence, and CDSCO liaison.

Talk to a Regulatory Expert Compare Device Classes
0Devices Registered
0Risk Classes Covered
0Avg. Turnaround
0Approval Success Rate
Device Registration
CDSCO Risk-Based Classification & Licensing
ALow
BLow-Mod
CMod-High
DHigh
License FormMD-9 / MD-15
AuthorityCDSCO
StatusActive
Classifications

Which registration route fits your device?

CDSCO groups devices by risk class and business activity — each route carries a different documentation and review load. Here's the full lineup we handle, at a glance.

Class A — Low Risk

Covers low-risk devices like surgical dressings and thermometers, registered under a simplified self-certification-backed route.

Fastest Route

Class B — Low-Moderate Risk

Applies to devices such as syringes and infusion sets, needing a State Licensing Authority review with basic technical documentation.

Class C — Moderate-High Risk

Covers devices like ventilators and dialysis machines, requiring CDSCO-level review with clinical and testing evidence.

Class D — High Risk

Applies to implants and life-supporting devices, undergoing the most rigorous CDSCO scrutiny and clinical data review.

Import License (MD-15)

Authorizes an Indian entity to import a registered device for sale and distribution within the country.

Manufacturing License (MD-9)

Permits domestic manufacture of a device at a facility that meets ISO 13485 quality management standards.

Loan License

Lets a business manufacture devices at another licensed manufacturer's approved facility, without owning a plant.

In-Vitro Diagnostic (IVD) Registration

Covers diagnostic kits and reagents used outside the body, classified and licensed under their own risk-based IVD route.

The Process

From classification to license, in eight steps

Here's exactly what happens between deciding to register and holding an active CDSCO license in hand.

1

Device Risk Classification

We assess your device against Medical Device Rules criteria to confirm whether it falls under Class A, B, C, or D.

2

Testing & Evidence Compilation

Lab test reports, clinical evidence, and safety data are compiled to match your device's classification requirements.

3

Document Compilation

Device Master File, Plant Master File, and quality certifications are gathered and verified ahead of filing.

4

Authorized Agent Appointment

Foreign manufacturers appoint an Indian Authorized Agent to file and liaise with CDSCO on their behalf.

5

Application Filing

The complete MD-3, MD-5, MD-9, or MD-15 application is filed electronically on the CDSCO SUGAM portal.

6

Technical Review & Site Audit

CDSCO reviews technical documentation and, for manufacturing licenses, conducts a facility audit against ISO 13485 standards.

7

Query Resolution

Any deficiency queries raised by the authority are addressed promptly to keep the approval timeline on track.

8

License Grant

Once approved, CDSCO issues your registration certificate — the legal proof your device can now be marketed in the country.

Eligibility

Who can register a medical device?

Requirements vary by risk class and whether you manufacture, import, or distribute, but most applications share the same baseline criteria under the Medical Device Rules.

Authorized Indian Agent

Foreign manufacturers must appoint an Indian Authorized Agent to file and correspond with CDSCO on their behalf.

ISO 13485 Quality System

Manufacturing sites must operate under a certified quality management system matching the device's risk class.

Qualified Technical Staff

A competent technical person overseeing quality, testing, and regulatory compliance at the manufacturing site.

Valid Test License

A test license where required, to legally manufacture limited quantities for trials or evaluation before full registration.

No Prior Disqualification

Applicants must have no history of license cancellation or pending regulatory action against the device or facility.

Conformity to Essential Principles

The device must meet the safety and performance essential principles laid down under the Medical Device Rules.

Paperwork

Documents you'll need to keep handy

Gathering these upfront is the single biggest thing you can do to speed up your CDSCO review and avoid deficiency queries.

Device Master File

Technical design and manufacturing details

Plant Master File

Facility layout and quality processes

ISO 13485 Certificate

Quality management system certification

Free Sale Certificate

For imported devices, from origin country

Test License

Where applicable, for trial manufacturing

Labeling & IFU

Product labels and instructions for use

Undertaking

Declaration of compliance with device rules

Class-Wise Checklist

Supporting evidence specific to risk class

Why It's Worth It

What device registration actually buys you

Beyond the legal formality, CDSCO registration changes what your device can do in the market and how protected your business is while selling it.

Legal Market Access

Sell, import, or manufacture without risk of seizure

Hospital Procurement Eligibility

Qualify for institutional and government tenders

Buyer Credibility

Distributors and clinicians trust a registered device faster

Cross-Border Trade

Registration supports export and import documentation

Traceability & Recall Systems

Structured records for faster response if issues arise

Reduced Liability Exposure

Documented compliance limits legal and financial risk

Brand Recognition

A licensed device builds long-term market trust

Quality Assurance

Ongoing conformity to safety and performance standards

After Registration

Staying compliant, year after year

Registration is the start, not the finish — here's what keeps your device license in good standing afterward.

License Renewal

Renewal application filed before expiry to keep the registration active and uninterrupted.

Adverse Event & Vigilance Reporting

Timely reporting of device-related incidents to CDSCO under the vigilance framework.

QMS Surveillance Audits

Periodic audits to confirm the manufacturing site continues to meet ISO 13485 standards.

Post-Market Surveillance

Ongoing monitoring of device performance and safety once it's in active use.

Labeling Updates

Labels and instructions for use kept current with any design or regulatory changes.

Change Notification to CDSCO

Material changes to the device, site, or manufacturer reported to the authority promptly.

Why Hisho & Kanri

Registration handled by people who do this daily

We've guided enough manufacturers and importers through CDSCO registration to know exactly where classification and audits usually go wrong — and how to avoid it.

Regulatory Specialists

Consultants who track CDSCO requirements and file device applications every week.

Fast Processing

Documents reviewed and filed without the back-and-forth delays.

Affordable Pricing

Transparent packages with no hidden government-fee surprises.

Audit Readiness

We prep your facility and files so the CDSCO site audit goes smoothly.

Dedicated Support

One point of contact from your first call through license issuance and renewal.

Secure Documentation

Your technical and business documents handled under strict confidentiality.

FAQ

Common questions about medical device registration

Can't find your question here? Use the form alongside this page and we'll answer it directly.

It's the CDSCO licensing process under the Medical Device Rules, 2017, that authorizes a device to be manufactured, imported, or sold legally.

Classification depends on intended use, duration of contact with the body, and invasiveness — our experts assess this against the official classification rules.

Yes, an Authorized Indian Agent must file the application and act as the point of contact with CDSCO on the manufacturer's behalf.

Typically around 30 working days once all documents are in order, though it can vary by device class and query cycles.

Device Master File, Plant Master File, ISO 13485 certification, and labeling are the core set — see the Documents section above for the full list.

For manufacturing licenses, yes — CDSCO conducts a facility audit to verify quality systems before granting approval.

Related devices from the same manufacturer can sometimes be grouped under one application — we can confirm whether your product range qualifies.

Most licenses remain valid indefinitely once granted, subject to periodic fee payment and continued compliance — we can confirm your class-specific rule.

Vigilance reporting, QMS surveillance audits, labeling updates, and change notifications to CDSCO — see the Compliance section above.

Because we handle classification and CDSCO filings daily, keep you informed at every review stage, and stay on for compliance long after approval is done.