CDSCO Medical Device Registration
Medical devices sold in India must be registered with the Central Drugs Standard Control Organisation under the Medical Devices Rules. Earth Bond Solutions supports domestic manufacturers and importers with technical documentation, application filing, and regulatory query management across all device classes.
Estimated timeline: 30-180 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. Device technical file
Required document
- 2. ISO 13485 certificate
Required document
- 3. Free Sale Certificate from country of origin
Required document
- 4. Clinical or performance data if applicable
Required document
- 5. Importer or authorised agent details
Required document
Step-by-step process
Step 1: Classify device under Medical Devices Rules
Determine Class A, B, C, or D based on risk.Step 2: Prepare technical documentation file
Compile all required technical and safety documents.Step 3: Apply on SUGAM CDSCO portal
File application on the official CDSCO registration portal.Step 4: Respond to technical queries
Address information requests from CDSCO.Step 5: Facilitate audit or inspection if required
Prepare for CDSCO site or document review.Step 6: Receive registration or import licence
Collect approval and proceed to market.
Business and compliance benefits
• Legal compliance to sell medical devices — Mandatory for all medical devices under Medical Devices Rules.
• Import licence for foreign devices — Formal approval to import and distribute in India.
• Structured technical documentation — Guidance on preparing the required technical file.
• Experienced regulatory guidance — Support through CDSCO queries and inspections.
Expected completion window
30-180 days
CDSCO Medical Device Registration questions
Yes. All medical devices listed under the Medical Devices Rules require CDSCO registration before sale or import.
Class A devices are low risk and Class D are the highest risk. Higher classes require more rigorous documentation and review.