CDSCO Sugam Portal: Complete Guide to the CDSCO Registration Process

Bringing medical devices into the Indian market demands strict adherence to the regulatory system managed by the Central Drugs Standard Control Organization. The Medical Devices Rules, 2017 form the core legal framework, and the SUGAM online system acts as the single digital gateway for nearly all related filings. This guide explains the full process in clear, practical terms so manufacturers, importers, and Indian agents can move forward with confidence.

What the SUGAM Portal Actually Is?

SUGAM (System for Unmanned Gateways Approval of Manufacturers) is CDSCO’s official e-governance platform. It is available at cdscoonline.gov.in, with a dedicated medical-device section at cdscomdonline.gov.in. Every application for manufacturing licences, import licences, test licences, and related permissions under the 2017 Rules must be filed electronically through this system. Physical paper files are no longer accepted for the standard pathways.

The portal lets applicants create accounts, upload dossiers, pay fees, track status in real time, answer queries, and download the final licences once granted.

Risk Classification Under the Medical Devices Rules, 2017

Before any form is opened, the device must be correctly classified. The Rules place every medical device and IVD into one of four risk classes:

• Class A – lowest risk
• Class B – low-to-moderate risk
• Class C – moderate-to-high risk
• Class D – highest risk

Classification follows the rules set out in the First Schedule. The class decides both the licensing authority and the exact form that must be used. State Licensing Authorities issue manufacturing licences for Class A and Class B devices. The Central Licensing Authority (CDSCO) issues manufacturing licences for Class C and Class D devices and issues all import licences regardless of class.

Foreign manufacturers are not permitted to file applications themselves. They must appoint an Indian Authorised Agent who holds a valid wholesale licence and who submits every application on their behalf.

Creating an Account on the SUGAM Portal

1. Open https://cdscoonline.gov.in.
2. Choose “Sign Up Here.”
3. Select the correct applicant category (Importer, Indian Agent, Foreign Enterprise with Indian Subsidiary, or Corporate/Manufacturer).
4. Enter the organisation’s full legal name, authorised person’s details, official email address, mobile number, and complete address.
5. Upload identity proof, address proof, authorisation letter or Power of Attorney (where required), and the signed undertaking.
6. Submit the form and confirm the email verification link.

After email confirmation, hard copies of the same documents must be delivered to the concerned CDSCO office for physical verification. Once verification is complete, login credentials are sent to the registered email. Units that already fall under a registered corporate entity can obtain credentials from that corporate user instead of creating a separate account. Users may hold several roles under one login and switch between them as needed.

Selecting the Correct Application Form

Using the wrong form is one of the most common reasons for delay. The principal forms under the 2017 Rules are:

• MD-3 → manufacturing licence for Class A or B devices (licence issued as MD-5 by the State Authority)
• MD-7 → manufacturing licence for Class C or D devices (licence issued as MD-9 by the Central Authority)
• MD-14 → import licence for any class (licence issued as MD-15 by the Central Authority)
• MD-12 / MD-16 → test licences for clinical investigation, evaluation, demonstration or training
• MD-41 / MD-42 → registration for sale, stock or distribution

Corresponding loan-licence forms (MD-4/MD-6 and MD-8/MD-10) exist for loan manufacturing arrangements. All of these are submitted exclusively through the medical-device portal.

Building the Technical Dossier

The Fourth Schedule of the Medical Devices Rules, 2017 sets out the documentary requirements. A complete submission normally contains:

• Covering letter and the filled application form
• Proof of fee payment
• Firm constitution documents and evidence of site ownership or tenancy
• Plant Master File prepared according to Appendix I
• Device Master File prepared according to Appendix II (or Appendix III for IVDs)
• Valid ISO 13485 certificate
• Free-sale certificate or evidence of marketing approval in a reference country (when applicable)
• Authenticated Power of Attorney for foreign manufacturers
• Label artwork, Instructions for Use, and demonstration of conformity with the Essential Principles of Safety and Performance
• Clinical or performance evaluation data appropriate to the risk class
• Any additional documents listed in the official checklists published by CDSCO

All files must be clear PDFs and the information inside them must match the data entered on the portal exactly. Incomplete or inconsistent dossiers almost always generate queries.

Filing the Application and Paying Fees

After logging in, choose the correct division and form, complete every field carefully, and upload the full dossier. Fees are paid online through the portal’s payment gateway and are non-refundable.

The Second Schedule of the Rules sets the amounts:

• Class A or B manufacturing licence: ₹5,000 per manufacturing site plus ₹500 for each distinct device
• Class C or D manufacturing licence: ₹50,000 per site plus ₹1,000 for each distinct device
• Import-licence fees are denominated in US dollars and increase with risk class

A separate fee is charged for every distinct device or brand. Payment must be completed before the application can be finally submitted.

Review, Queries, Inspection and Grant of Licence

CDSCO or the State Authority examines the file. If clarification is required, a query appears in the portal status. The applicant must reply by uploading the requested material within the time allowed (commonly 45 days in current practice).

For Class B manufacturing sites a Notified Body may perform an audit. Class C and D applications may involve inspection or detailed technical review by the Central Authority. Once the authority is satisfied, the licence is generated electronically and becomes available for download. Licences remain valid for five years provided the prescribed retention fee is paid on time.

Applicants can check status at any moment under the “Submitted Applications” section. The same portal is also used for post-approval variations, retention applications and adverse-event reporting.

Practical Points That Reduce Delays

• Confirm classification before opening any form.
• Appoint a competent Indian Authorised Agent early if the manufacturer is located outside India.
• Keep every document current, legible and consistent with the portal entries.
• Answer queries completely and on time.
• Remember that certain non-sterile, non-measuring Class A devices have simplified registration routes under later notifications.

Support from MDR Consultants

MDR Consultants specialises in guiding companies through every stage of the CDSCO process under the Medical Devices Rules, 2017. From accurate classification and dossier preparation to portal registration, application filing, query management and post-licence support, the team works strictly according to current CDSCO guidelines. Whether the goal is an MD-5 or MD-9 manufacturing licence or an MD-15 import licence, professional assistance helps ensure the submission meets regulatory expectations and moves forward without unnecessary delay.

The SUGAM system has made the Indian regulatory pathway transparent and fully digital. When the steps described above are followed carefully and the documentation is prepared in line with the 2017 Rules, applicants can obtain the required licences efficiently and bring safe medical devices to the Indian market. Always cross-check the latest circulars and user manuals published on the official CDSCO websites, because requirements continue to be refined over time.

Last Updated : 29 Aug 2026