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Hisho & Kanri
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CDSCO Registration

Get your drug, device, or cosmetic cleared to enter the Indian market.

CDSCO Registration is the approval process administered by the Central Drugs Standard Control Organisation — India's national regulator for drugs, medical devices, cosmetics, and clinical trials. It's what confirms your product meets India's safety, quality, and efficacy standards before it can be imported, manufactured, sold, or trialled anywhere in the country.

Skip it, and shipments get held at customs, hospitals and distributors won't stock your product, and you risk penalties under the Drugs and Cosmetics Act. Get it right — the correct classification, the right licence form, a complete Device or Drug Master File — and your product moves from paperwork to prescription without the back-and-forth that usually stalls first-time applicants.

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0Products Registered
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Central Drugs Standard Control Organisation

Certificate of Registration

Issued under the Drugs & Cosmetics Act, 1940
Reg. No.MD/2026/XXXX
CategoryMedical Device
Risk ClassClass B
PortalSUGAM
StatusActive
Filed ByHisho & Kanri
Product cleared for the Indian market
At a Glance

From classification to certificate, in one continuous flow

CDSCO registration moves through four checkpoints. Each one has to clear before the next can begin — here's the whole journey in one view.

1

Classification

Product mapped to the right category & risk class

2

Dossier Compilation

Device/Drug Master File built & reviewed

3

SUGAM Portal Filing

Application submitted & queries resolved

4

CDSCO Certificate

Registration or licence issued

Registration Types

Which CDSCO registration does your product need?

The category and risk class you fall under decide your licence form, documentation depth, and review timeline. Here's the full lineup we handle.

Medical Device Registration

Covers Class A, B, C, and D devices under the Medical Device Rules, 2017 — from thermometers to implantables.

Most Popular

Import Licence for Drugs

Authorisation to import formulations or bulk drugs into India, filed by a registered Indian agent on behalf of the manufacturer.

Manufacturing Licence

Site and product-specific approval to manufacture drugs or devices within India, tied to GMP compliance.

Cosmetics Import Registration

Mandatory registration for cosmetic products imported into India, covering formulation and labelling review.

Clinical Trial Approval

Permission to conduct clinical investigations for new drugs or investigational devices at approved trial sites.

New Drug Application

Approval for a new chemical entity, fixed-dose combination, or new indication before it can be marketed in India.

Blood Bank & Biological Licence

Licensing for blood banks, blood products, and biological drugs under specialised CDSCO oversight.

Device Manufacturing Licence

Site licence for domestic manufacturers of medical devices, benchmarked against ISO 13485 quality systems.

The Process

From classification to certificate, in eight steps

Here's exactly what happens between identifying your product's regulatory category and holding a CDSCO registration certificate or licence.

1

Regulatory Classification

We determine whether your product is a drug, cosmetic, or medical device, and assign the correct risk class where applicable.

2

Gap Assessment

Existing certifications, test reports, and quality documents are reviewed against CDSCO's requirements to flag missing pieces early.

3

Dossier Compilation

The Device Master File or Drug Master File is compiled — technical data, labelling, GMP/ISO certificates, and free sale certificates included.

4

Test Licence (If Required)

Where testing or clinical evaluation is needed before full registration, a test licence is obtained first.

5

SUGAM Portal Application

The complete application and dossier are filed electronically through CDSCO's SUGAM online licensing portal.

6

Query Response & Technical Review

We respond to evaluator queries and clarifications, keeping the review moving without avoidable delays.

7

Inspection or Audit

For manufacturing licences, a facility inspection confirms GMP or ISO 13485 compliance before approval.

8

Registration Certificate Issued

On approval, CDSCO issues your registration certificate or licence, clearing your product for the Indian market.

Eligibility

Who can apply for CDSCO Registration?

Requirements vary by product category and risk class, but every application is checked against the same baseline conditions.

Compliant Manufacturing Site

A facility certified to GMP, ISO 13485, or the applicable quality standard for your product category.

Authorised Indian Agent

Foreign manufacturers must appoint an Indian agent holding a valid wholesale licence to file on their behalf.

Complete Master File

A Device Master File or Drug Master File with technical, clinical, and quality data ready for submission.

Free Sale Certificate

Proof that the product is freely sold and approved in its country of origin, for imported drugs and devices.

Qualified Regulatory Personnel

Access to regulatory affairs expertise capable of responding to technical queries during evaluation.

No Prior Regulatory Action

No active product recall, blacklisting, or licence cancellation against the applicant or manufacturer.

Paperwork

Documents you'll need to keep handy

Gathering these upfront is the single biggest thing you can do to speed up dossier review and reduce query cycles.

Device/Drug Master File

Complete technical & quality dossier

Plant Master File

Manufacturing site details & layout

ISO 13485 / WHO-GMP

Quality management certification

Free Sale Certificate

From the country of origin

Authorisation Letter

From manufacturer to Indian agent

Test Licence

Where testing or trials are required

Labelling & IFU

Product labels & instructions for use

Wholesale Drug Licence

Of the Indian agent, Form 20B/21B

Why It's Worth It

What CDSCO registration actually buys you

Beyond the legal formality, registration changes what your product can do in India and how fast it gets there.

Legal Market Access

Import, manufacture, and sell without regulatory risk

Patient Safety Assurance

Verified quality builds trust with prescribers and users

Faster Customs Clearance

Registered products move through import checks smoothly

Government Tender Eligibility

Access to public procurement and institutional supply

Distributor Credibility

Hospitals and distributors verify registration before stocking

Anti-Counterfeit Protection

A registered listing makes unauthorised copies easier to flag

Smoother Renewals

A clean filing history speeds up every future renewal

Multi-State Distribution

One central registration supports sales across India

After Registration

Staying compliant, cycle after cycle

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

Periodic Licence Renewal

Registration certificates and licences must be renewed before expiry to keep the product marketable.

Post-Market Surveillance

Ongoing monitoring of product performance once it's in active use or circulation.

Adverse Event Reporting

Pharmacovigilance or materiovigilance reporting for any adverse event linked to the registered product.

Manufacturing Site Change

Any change of manufacturing site or process must be intimated and, where needed, re-approved.

Labelling Compliance

Ongoing alignment of packaging and labelling with the latest CDSCO requirements.

Annual Data Submission

Periodic sales, import, or manufacturing data submitted as required by the licence category.

Why Hisho & Kanri

Registration handled by people who do this daily

We've filed enough CDSCO dossiers across drugs, devices, and cosmetics to know exactly where evaluators raise queries — and how to pre-empt them.

Regulatory Affairs Specialists

Consultants who work with CDSCO's SUGAM portal and licence forms every week.

Fewer Query Cycles

Dossiers built to pre-empt the objections that most commonly delay approval.

Transparent Pricing

Clear packages by category and risk class, with no hidden fee surprises.

Full Visibility

You see every filing and query response, not just a final certificate.

Dedicated Support

One point of contact from classification through certificate and renewals.

Secure Documentation

Your technical dossiers and quality certificates handled under strict confidentiality.

FAQ

Common questions about CDSCO Registration

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

The Central Drugs Standard Control Organisation is India's national regulator for drugs, medical devices, cosmetics, and clinical trials, functioning under the Ministry of Health & Family Welfare.

Yes, all notified medical devices must be registered under the Medical Device Rules, 2017 before they can be imported, manufactured, or sold.

Devices are graded Class A (low risk) through Class D (high risk), with documentation and review depth increasing at each level.

It ranges from a few weeks for low-risk devices to several months for new drugs or high-risk devices, depending on category and query cycles.

SUGAM is CDSCO's online platform for filing, tracking, and managing licence applications for drugs, devices, and cosmetics electronically.

An import licence authorises bringing a finished product into India, while a manufacturing licence authorises producing it at a facility within India.

Yes, imported cosmetics require registration before they can be sold in India, covering formulation safety and label compliance.

CDSCO requires a locally accountable point of contact holding a valid wholesale licence to file and correspond on the foreign manufacturer's behalf.

Validity depends on the licence category — most registrations run for a fixed term and must be renewed before expiry to stay active.

Because we handle classification, dossier compilation, and SUGAM filings every week, keep you informed at every query stage, and stay on for renewals and surveillance reporting after approval.