CDSCO is the Central Drugs Standard Control Organization, the national regulator for drugs and medical devices in India.

What is the SUGAM portal?

SUGAM is the online platform used by CDSCO to manage registrations, licenses, and clinical trial approvals.

Is registration mandatory for all medical devices?

Yes, as of 2023, almost all medical devices in India are under mandatory regulation and require CDSCO registration.

Who can be an 'Authorized Agent'?

For foreign manufacturers, an Authorized Agent must be an Indian entity with a valid Wholesale Drug License.

What is Class A and Class B?

Class A (Low Risk) and Class B (Low-Moderate Risk) devices are typically regulated by the State Licensing Authority (SLA).

What is Class C and Class D?

Class C (Moderate-High Risk) and Class D (High Risk) devices are directly regulated by the Central Licensing Authority (CLA/CDSCO).

It is the international standard for Quality Management Systems specific to the medical device industry.

How long does registration take?

Depending on the device class and data readiness, it usually takes 3 to 9 months.

Service

CDSCO Registration Online

Expert assistance for CDSCO registration. We help with SUGAM portal filing, medical device classification (Class A-D), and manufacturing licenses.

The National Standard for Medical Safety

Expert assistance for CDSCO registration. We help with SUGAM portal filing, medical device classification (Class A-D), and manufacturing licenses.

Obtain mandatory registration from the Central Drugs Standard Control Organization (CDSCO) for importing and manufacturing medical devices and drugs in India.

The national gate for medical products. Register with the CDSCO to legally manufacture or import drugs, medical devices, and diagnostics in India.

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Similar to the FDA in the US, the CDSCO is responsible for the approval of new drugs, conduct of clinical trials, and setting the standards for drugs and medical devices across the country.

Under the Medical Devices Rules, 2017, the regulation of medical devices has been significantly tightened. Devices are now classified based on their risk level, and manufacturers/importers must obtain the relevant CDSCO registration to operate legally. The entire process is managed online through the SUGAM portal.

QuickTaxperts provides specialized regulatory consulting for medical device companies, helping them classify their products correctly and managing the complex technical filing process with the central and state drug controllers.

Category: Health & Medical
Registration is mandatory for both domestic manufacturers and foreign importers.
Covers specialized items like Stents, Orthopedic Implants, and IVD kits.
Requires high-quality documentation including Site Master Files and Device Master Files.
Mandatory adherence to ISO 13485 (Quality Management System for Medical Devices).
Mandatory for all medical devices, drugs, and cosmetics
Registration via the SUGAM online portal
Covers Import Licenses, Manufacturing Licenses, and Clinical Trials
Regulated under the Medical Devices Rules, 2017

Medical Device Classification

Identifying the risk level of your product.

Class A: Low Risk (e.g., Bandages, Tongue Depressors).
Class B: Low to Moderate Risk (e.g., Hypodermic Needles, Suction Equipment).
Class C: Moderate to High Risk (e.g., Lung Ventilators, Bone Fixation wires).
Class D: High Risk (e.g., Heart Valves, Implantable Defibrillators).

Documents required

Document requirements vary by entity type, state, premises, and authority. These are the usual groups we verify before submission.

CDSCO Checklist: ISO 13485 Certificate (Quality Management System).; Plant Master File and Site Master File.; Device Master File (Technical specifications and testing data).; Free Sale Certificate (for imported devices).; Full list of ingredients/materials used.; Clinical investigation data (for high-risk devices).; Undertaking regarding post-market surveillance.

Process and timeline

Classification: Determining the correct class (A, B, C, or D) for the medical device.
SUGAM Registration: Creating a corporate account on the CDSCO SUGAM portal.
Application Filing: Submitting the application for an Import License or Manufacturing License.
Review & Query: Responding to technical clarifications raised by the CDSCO reviewers.
Audit/Inspection: Coordinating the physical inspection of the manufacturing site (if required).
Grant of License: Receiving the final CDSCO registration certificate or license.

Expert review

CDSCO Registration Online content is reviewed by QuickTaxperts Medical Regulatory Team, CDSCO Compliance Specialists.

Checklist-led review
Document pre-verification
Authority-specific next steps

Frequently asked questions

These quick answers cover common planning questions before you request a checklist or quote.

What is CDSCO?: CDSCO is the Central Drugs Standard Control Organization, the national regulator for drugs and medical devices in India.
What is the SUGAM portal?: SUGAM is the online platform used by CDSCO to manage registrations, licenses, and clinical trial approvals.
Is registration mandatory for all medical devices?: Yes, as of 2023, almost all medical devices in India are under mandatory regulation and require CDSCO registration.
Who can be an 'Authorized Agent'?: For foreign manufacturers, an Authorized Agent must be an Indian entity with a valid Wholesale Drug License.
What is Class A and Class B?: Class A (Low Risk) and Class B (Low-Moderate Risk) devices are typically regulated by the State Licensing Authority (SLA).
What is Class C and Class D?: Class C (Moderate-High Risk) and Class D (High Risk) devices are directly regulated by the Central Licensing Authority (CLA/CDSCO).
What is ISO 13485?: It is the international standard for Quality Management Systems specific to the medical device industry.
How long does registration take?: Depending on the device class and data readiness, it usually takes 3 to 9 months.