In Vitro Diagnostics Registration
IVD CDSCO Registration
Helped many global brands achieve compliance
Looking for expert assistance for In Vitro Diagnostics (IVDs) CDSCO Registration? Click to know all about In Vitro Diagnostics (IVDs) CDSCO Registration process.
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Simple Step-by-Step Process
IVD Classification
Classify IVD under IVDR 2017 (Class A/B/C/D).
Documentation
Prepare technical file and performance data.
Testing
Get IVD tested at approved laboratories.
CDSCO Application
Submit application on CDSCO portal.
Registration Grant
Receive CDSCO IVD registration certificate.
Required Documents
Why Choose JR Compliance?
JR Compliance provides comprehensive IVD registration services under CDSCO guidelines and Medical Device Rules 2017 for manufacturers and importers of diagnostic products. Our regulatory experts assist with accurate device classification under Class A, B, C, or D categories based on risk assessment and intended use. We help compile complete technical documentation including device master files, analytical performance validation data, and clinical evidence required for IVD approval. Our team manages the entire SUGAM portal submission process, coordinates testing requirements, and handles CDSCO correspondence. We assist with manufacturing license applications, import registration for foreign IVDs, and post-market surveillance requirements. Post-approval, we provide ongoing support for license renewals, product modifications, and vigilance reporting to maintain your IVD market authorization.
Speed
Quotes in seconds, certification in days!
Expert Guidance
Dedicated support, quick replies!
Quality
Expert guidance, 100% compliance!
Mandatory for IVD market access in India
Class A, B, C, D IVD registration
Import and manufacturing license
Expert regulatory guidance
Clinical performance evaluation
Quality management compliance
Quick processing
Renewal support
Pan-India distribution
Frequently Asked Questions
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In Vitro Diagnostics Registration