Device status and classification
Intended-use assessment, applicable software category, First Schedule rule, published CDSCO entries and documented Class A, B, C or D rationale.
India CDSCO SaMD Approval
CDSCO licensing for medical device software in India.
We help Indian manufacturers and overseas companies define device status, risk class, licensing route and dossier requirements for SaMD under the Medical Devices Rules, 2017.
Selected clients
Healthcare teams we have supported
Scope and deliverables
CDSCO application work included in the service.
Requirements depend on class, activity, manufacturing sites, product origin and available evidence. “CDSCO approval” is not one universal application.
Route, authority and form
Manufacture versus import pathway, State or Central Licensing Authority, test-license or investigation needs and form-to-license map.
Applicant and grouping strategy
Indian legal entity or Authorized Agent readiness, site and product grouping, overseas manufacturer records and power-of-attorney inputs.
Device Master File
Device description, intended use, design, risk, verification and validation, software lifecycle, clinical evidence, labeling and Essential Principles evidence.
Quality and legal dossier
Plant/Site Master File inputs, QMS evidence, Free Sale or market-history records where applicable, undertakings and authenticated legal documents.
Portal and query support
Application data preparation, controlled upload set, completeness review and evidence-based support for licensing-authority questions.
Ways to work together
Choose the support your team needs.
Classification and route memo
A focused opinion on status, class, authority, forms, key evidence and unresolved questions.
Application dossier support
Coordinate Device Master File and agreed application records through filing readiness and review queries.
Existing dossier remediation
Assess a stalled application or deficiency and structure the technical and documentary response.
How it works
Our process.
- 1
Characterize
Confirm claims, software functions, sites, applicant and intended commercial activity.
- 2
Classify and scope
Document class, authority, application, grouping and evidence requirements.
- 3
Compile and check
Build technical, quality and legal records with controlled cross-references.
- 4
File and support
Prepare portal data and respond to authority questions within the agreed role.
Regulations, standards and guidance considered
Medical Devices Rules, 2017First ScheduleFourth ScheduleEssential PrinciplesISO 13485ISO 14971IEC 62304IEC 62366-1
Frequently asked questions
Questions teams ask before they begin.
Which forms apply to manufacture and import?+
The route depends on class and activity. Common commercial routes include MD-3 to MD-5 for Class A/B manufacture, MD-7 to MD-9 for Class C/D manufacture, and MD-14 to MD-15 for imports. Exemptions, loan licenses and current amendments must be checked.
Does software that controls another device have its own class?+
Software that drives or influences a device generally falls in the same class as that device under the First Schedule. Standalone software is classified on its own intended use and applicable rules and published classifications.
What applies to Class A non-sterile, non-measuring software?+
Such devices are exempt from licensing but remain subject to mandatory online registration and applicable quality, labeling and post-market obligations. The exemption should be supported by a documented classification.
Can an overseas manufacturer apply directly?+
Import applications are generally made through an Authorized Agent in India meeting MDR 2017 requirements. The overseas manufacturer, sites and agent provide the prescribed authenticated records.
Is foreign clearance enough for an Indian license?+
No. Foreign market authorization may support the application, but the Indian route and Fourth Schedule documentation still apply. The authority may require additional evidence or clarification based on class and product history.
Can you guarantee the license?+
No. The applicable licensing authority decides the application and may raise queries or require testing, inspection or additional evidence.
Start with the product you have