CDSCO Medical Device Registration
CDSCO registration applies to medical devices, diagnostics, and healthcare products regulated in India. Requirements vary by device classification, risk level, manufacturer location, and import status. Earth Bond Solutions supports product classification, document gap review, application preparation, importer/manufacturer coordination, and regulatory follow-up for eligible medical device cases.
Estimated timeline: 30-120 working days
Who needs this service?
This service is suitable for manufacturers, importers, and product teams that need regulatory clearance before sale or launch.
Required documents
- 1. Company and license documents
Business registration, wholesale license where applicable, and applicant identity documents.
- 2. Device technical file
Device description, intended use, specifications, labels, and IFU/manual.
- 3. Quality certificates
ISO 13485, CE, free sale certificate, or other quality documents where applicable.
- 4. Manufacturer authorization
Required for importers or authorized Indian agents.
- 5. Test and safety documents
Performance, safety, biocompatibility, or clinical documents depending on device class.
Step-by-step process
Step 1: Device classification
We identify whether your product is regulated and map the applicable device class.Step 2: Document gap review
We review technical, quality, manufacturer, and importer documents.Step 3: Application preparation
We prepare the applicable CDSCO filing package.Step 4: Portal submission
We support online filing and department communication.Step 5: Approval and compliance guidance
We guide certificate use, post-approval obligations, and renewal tracking.
Business and compliance benefits
• Healthcare market readiness — Supports regulated sale or import of medical devices in India.
• Risk-class clarity — Avoids wrong route selection for device registration.
• Technical document structure — Organizes device files for authority review.
Expected completion window
30-120 working days
Pricing note: Fee depends on device class, applicant type, technical file complexity, and import/manufacturer role.
Government fee note: CDSCO government fees are separate and depend on application type and device category.
CDSCO Medical Device Registration questions
Many medical devices are regulated, and coverage continues to evolve. We confirm applicability before filing.
Yes, import registration often requires manufacturer authorization and technical or quality documents.
Timelines depend on device class, document completeness, and department review. Many cases take several weeks to months.