CDSCO In Vitro Diagnostics Registration

Who Needs This Service

Manufacturers and importers of diagnostic test kits and reagents, rapid tests, blood glucose strips, HIV, HBV and HCV kits, molecular tests and IVD analysers, and their Indian authorised agents, need IVD registration.

Startups developing diagnostics should plan performance evaluation early.

Any new IVD needs clinical performance evaluation.

If your kit is for research use only, check status.

Key Benefits

• Route identified by class
• Performance evaluation planned
• Documents prepared
• Portal filing
• Import or manufacturing licence obtained

Next Steps & Related Services

After licensing, comply with post-market requirements. Related services: MDR registration, MD-15, MD-9 and GMP.

Common Mistakes

• Wrong class.
• Missing evaluation.
• Weak stability data.
• No MD-42 agent.
• Unpaid retention fee.

Timeline, Costs & Practical Tips

Timelines depend on evaluation.

Practical tip: schedule evaluation early.

Additional Information

MDR 2017 treats IVDs as devices with risk-based classification.

Practical Scenarios

Scenario 1:

A rapid test maker licenses.

Scenario 2:

An importer registers kits.

Scenario 3:

A startup plans evaluation.

Process & Planning

An IVD plan starts with risk classification using CDSCO's lists. Decide whether you will import (MD-14 and MD-15 with an MD-42 agent) or manufacture (MD-3 and MD-5 for Class A and B, MD-7 and MD-9 for Class C and D), and whether you need a test licence (MD-12, MD-13, MD-16, MD-17) or clinical performance evaluation (MD-24 and MD-25). Arrange performance evaluation at a listed lab such as NIB for notified kits, assemble the Device Master File, ISO 13485 certificate and stability and analytical data, then file. Planning checklist: book evaluation slots early, keep documents in English, plan the retention fee and track classification list updates.