Consultation & Requirement Analysis
We learn the product, the entity that will sell it, and which Indian approvals actually apply.
Medical Devices & Healthcare
How this approval works
A device’s risk class decides the licence: some products need registration, others an import or manufacturing licence, and many need an authorised Indian agent when the manufacturer is overseas.
We confirm classification, list the technical documents the class requires, and keep the device description, intended use, and labelling consistent across the file.
Who it is for
- Importers of notified medical devices
- Overseas manufacturers who need an Indian authorised agent
- Domestic brands preparing a manufacturing or registration file
What we handle
- Risk-class and pathway check
- Technical file outline for the class
- Authorised-agent documentation where required
- Application support through queries
Papers usually required
- Device description and intended use
- Labels, IFU, and quality certificates
- Predicate or classification rationale
- Manufacturing site and free-sale or ISO evidence as applicable
The same four steps
Documentation & Application Support
We prepare, check, and manage the forms, authorisations, and technical papers the authority expects.
Testing & Regulatory Coordination
We coordinate laboratories where a test is required and stay on the file while the authority reviews it.
Approval & Market Readiness
You receive the registration, licence, or clearance, with the label and model details aligned to it.