IVD Registration and IVD Import License in India

In vitro diagnostic devices – reagents, kits, calibrators, analysers and software used to examine specimens from the human body – are regulated in India under the same Medical Devices Rules, 2017 as other devices, with their own classification rules. Medfins International is an IVD regulatory consultant helping manufacturers and importers secure IVD registration in India quickly and correctly.

How IVDs are regulated in India

CDSCO classifies IVDs as Class A, B, C or D using the IVD rules in Part II of the First Schedule. Classification depends on the intended use and the risk to the individual and to public health: tests that screen blood for transfusion-transmissible agents and key blood grouping markers fall in Class D, while general laboratory reagents sit in Class A. Since October 2023, IVDs of every class need a licence.

IVD import license in India

Overseas IVD manufacturers enter India through an Indian authorised agent who applies in Form MD-14 and holds the MD-15 import licence. The application includes the Device and Plant Master Files, the free sale certificate, the ISO 13485 certificate, labels and instructions for use, and performance evaluation data. Read more in our CDSCO import license guide.

IVD manufacturing licence

Indian IVD manufacturers apply in Form MD-3 (Class A and B, State Licensing Authority) or Form MD-7 (Class C and D, Central Licensing Authority), leading to the MD-5 or MD-9 licence. Sites are audited by a notified body or inspected by CDSCO depending on class. See our medical device manufacturing license service.

Performance evaluation for IVDs

CDSCO expects performance evaluation evidence for IVDs, and for certain higher-risk kits it requires evaluation by a laboratory designated by CDSCO before licensing. Analytical sensitivity and specificity, precision, stability and clinical performance data should be organised in the dossier so the reviewer can find them quickly. A new IVD with no predicate in India needs separate permission before licensing – see our guide to new IVD approval in India.

IVD registration process, step by step

1. Confirm the IVD class under Part II of the First Schedule and whether the product is a new IVD in India.
2. Appoint the Indian authorised agent (for imports) and confirm its licence status.
3. Compile the Device Master File: intended use, principle of the test, design and manufacturing, stability, labelling and performance data.
4. Compile the Plant Master File and ISO 13485 evidence for each manufacturing site.
5. Arrange performance evaluation where CDSCO requires it, and gather the free sale certificate.
6. File on the CDSCO portal with the fee, respond to queries and receive the licence.
7. Maintain the licence: retention fee every five years, post-approval changes and post-market vigilance.

Our IVD registration services

• IVD classification and regulatory strategy for India
• Device Master File and Plant Master File preparation for kits, reagents and analysers
• Indian authorised agent service and MD-15 IVD import licence
• MD-5 and MD-9 manufacturing licences for Indian IVD manufacturers
• Performance evaluation planning and coordination with designated laboratories
• EU IVDR CE marking and US FDA support for IVD exporters

Ready to start? Book a free consultation with Medfins International or call +91 85270 48221.

Frequently asked questions