Who this is for
Indian manufacturers, importers and overseas manufacturers preparing an India medical-device route.
Medical Devices
CDSCO Medical Device Licensing & Market-Entry Support
Identify the applicable India market-entry route before preparing an application. ConformArc coordinates classification review, document planning and specialist application support. The pathway depends on the product, risk class, manufacturing location and intended activity; licence or registration decisions remain with the competent authority.
Typical scope
- Route and classification input review
- Manufacturer-versus-importer responsibility map
- Dossier and evidence checklist
- Testing and QMS evidence mapping
- Application-readiness and deficiency-response coordination within the agreed scope
Useful inputs for an initial review
- Device description and intended use
- Manufacturer and manufacturing-site details
- India business model: manufacture/import/other
- Known classification and existing approvals if any
- Existing technical and QMS evidence
Accuracy note. Do not treat registration as the route for every device. Current classification, licensing authority, forms, fees, exemptions and notifications must be checked for the actual device before publication or advice.
Role clarity. ConformArc provides project scoping, readiness support and coordination within an agreed service scope. Where independent testing, certification, verification or regulatory review is required, the relevant work and decisions remain with the appointed laboratory, assessment body, verifier or authority. Outcomes and timelines depend on the product, evidence and applicable requirements.
Frequently asked questions
Does every medical device follow the same India application route?
No. The route depends on the device, risk class, manufacturing location and activity.
What should be reviewed before preparing the dossier?
At minimum, intended use, classification, manufacturer/importer roles, QMS evidence, test evidence and the current regulatory route should be checked.
Who makes the licence decision?
The competent authority makes the regulatory decision. ConformArc's role is support and coordination within the agreed scope.
Need a clearer route before you commit to testing or certification?
Share the product, target market and current project stage. ConformArc will review the enquiry, identify the likely workstreams and confirm what information is needed next. Any specialist work, laboratory activity, certification assessment, regulatory submission or verification scope is agreed separately.