Form MD-15 (Import License)

Who Needs This Service

Importers and foreign manufacturers (through Indian authorised agents) of medical devices and IVD kits sold in India need MD-15.

Agents should first obtain MD-42.

Brands importing multiple devices should list all models.

If you import for testing only, use MD-16 or MD-17.

Key Benefits

• Legal import of medical devices
• MD-14 and documents prepared
• Agent and manufacturer documents aligned
• Portal filing
• Retention fee tracking

Next Steps & Related Services

After MD-15, import and distribute under conditions. Related services: MD-42, MDR registration and IVD registration.

Common Mistakes

• Applying without MD-42.
• Missing manufacturer approvals.
• Incomplete DMF.
• Unpaid retention fee.
• Importing before licence.

Timeline, Costs & Practical Tips

Timelines depend on CDSCO scrutiny.

Practical tip: keep ISO 13485 and approvals ready.

Additional Information

MDR 2017 requires import licences for devices to ensure quality and safety.

Practical Scenarios

Scenario 1:

A distributor imports implants.

Scenario 2:

An agent imports diagnostic devices.

Scenario 3:

A brand updates models.

Process & Planning

To obtain an MD-15 import licence, first confirm that your Indian entity holds a valid MD-42 wholesale licence and has authority from the foreign manufacturer. Prepare the manufacturer's regulatory approvals, ISO 13485 certificate, Device Master File, labelling and instructions for use, technical or clinical data and, for notified IVDs, performance evaluation reports. File Form MD-14 on the CDSCO portal with fees, respond to queries and receive MD-15. Planning checklist: list every model and manufacturing site, keep all documents in English, track the five-year retention fee and update the licence when products or sites change.