Device status
Does the software meet the notified medical-device definition based on its intended use and claims?
India CDSCO regulatory market
CDSCO approval for medical device software in India.
We help manufacturers and importers assess medical-device status, risk class, licensing authority, application route and technical evidence under India’s Medical Devices Rules, 2017.
Discuss your market plan →Pathways and services
Regulatory support for India CDSCO.
India market access
CDSCO SaMD approval
Status, classification, application strategy, Device Master File and portal-ready dossier support.
View service →EvidenceClinical evidence
Evidence-gap review and regulatory strategy for the product and proposed Indian route.
View service →Use safetyHuman factors and usability
Proportionate usability engineering and use-related risk documentation.
View service →LifecyclePost-market surveillance
Complaint, trend, vigilance and field-action process design for ongoing compliance.
View service →What we need to determine
The decisions that shape your application.
Risk class
Which First Schedule rule and CDSCO classification entry apply, including software that drives or influences another device?
Commercial route
Is the application for Indian manufacture, import, test license or an investigational device—and which authority and form apply?
Evidence and QMS
Which technical, quality, safety, performance and clinical documents are required for this device and pathway?
How we work
From classification to market entry.
- 1
Define
Confirm intended use, software boundaries, manufacturer, importing entity and commercial model.
- 2
Classify
Document classification, licensing authority, form, grouping and applicable exemptions.
- 3
Compile
Prepare the Device Master File, quality and legal records, evidence summaries and application data.
- 4
File and maintain
Support portal submission and questions, then establish license-condition and vigilance controls.
Core regulations, standards and guidance
Drugs and Cosmetics Act, 1940Medical Devices Rules, 2017First ScheduleFourth ScheduleEssential PrinciplesISO 13485ISO 14971IEC 62304
FAQ
Common questions about India CDSCO.
CDSCO classifications, forms, portal procedures and guidance are updated over time. Product-specific advice should be checked against the current Act, MDR 2017 amendments, notices and licensing-authority practice.
Is “CDSCO approval” one universal certificate?+
No. The legal outcome depends on the activity and device: manufacturing or import licenses, registrations, test licenses and permissions use different forms and authorities. “Approval” is common shorthand, but the precise route should be named in the project plan.
Who licenses Class A and B versus Class C and D manufacture?+
Under MDR 2017, manufacture of Class A and B devices is generally handled by the State Licensing Authority, while Class C and D manufacture is handled by the Central Licensing Authority. Import licensing is handled centrally. Specific exemptions and current portal procedures still need confirmation.
Does imported SaMD need an Indian Authorized Agent?+
An overseas manufacturer generally applies for an import license through an authorized agent in India that meets the applicable requirements. The agent relationship, device sites and supporting documents should be confirmed before preparing the application.
Is Class A software exempt from all regulation?+
No. Class A non-sterile, non-measuring devices are exempt from licensing, but registration and other applicable MDR 2017 obligations remain. Classification and eligibility for the exemption must be supported rather than assumed.
Can a license timeline or outcome be guaranteed?+
No. The licensing authority controls review, questions and the decision. Completeness, classification, overseas evidence and inspections or testing can affect the process.