Initial regulatory assessment
- Device and intended-use information review
- Classification and rule applicability assessment support
- Manufacturing / import model review
- Gap list and regulatory roadmap
India regulatory support
From site readiness to licensing dossier support.
Documentation and project coordination support for medical device manufacturers assessing applicable Indian regulatory requirements and preparing licensing submissions.
Potential engagement stages
The exact route, forms, licenses and evidence depend on the device category, risk class, manufacturing/import model, and current Indian regulatory requirements.
Manufacturing-site readiness
- QMS and document-control gap assessment
- Facility and process documentation checklist
- Equipment, calibration and maintenance records review
- Supplier, production and release-record readiness
Technical dossier preparation
- Device master / technical documentation compilation, as applicable
- Essential Principles checklist and evidence index
- Risk management and verification / validation records
- Labeling, IFU and packaging documentation
Application and query support
- Application document checklist and compilation
- Submission status and deficiency tracker
- Drafting support for responses to regulator queries
- Coordination with the applicant and authorized representatives
Inspection and audit preparation
- Mock documentation review
- Evidence index and record retrieval planning
- Finding / observation response support
- CAPA planning and follow-up tracker
Post-license maintenance
- Change assessment and variation planning
- License and compliance calendar
- Complaint, vigilance and post-market processes
- Periodic document review support
Important: Q Med can support planning, documentation, and coordination; it cannot itself issue a government license, guarantee approval, or replace inspections and decisions by CDSCO / the relevant State Licensing Authority. Verify the current applicable rules and application route before filing.