Import Authorization for
Novel IVDs (MD-26 & MD-27)
Navigate the complex regulatory pathway for introducing new, innovative In Vitro Diagnostic (IVD) devices to the Indian healthcare market.
Consult Our CDSCO Experts
What is a "New" IVD Device?
Bringing a novel In Vitro Diagnostic (IVD) medical device to India requires precise regulatory approval. Under the Medical Devices Rules, 2017, a "new IVD medical device" generally refers to a diagnostic product that has not been previously approved in India, or an existing device that has undergone significant modifications.
Form MD-26
The detailed application submitted to the Central Licensing Authority (CLA). It requires comprehensive data proving the device's safety, quality, and performance—particularly crucial when no "predicate device" exists.
Form MD-27
The official license granted by the Drug Controller General of India upon successful review of MD-26. It legally permits the import or manufacture of the new IVD in India.
The Detailed MD-26 Submission Process
Introducing a novel IVD device demands a highly structured and data-rich application via the CDSCO's Sugam portal. Key steps include:
Classification & Scope
Accurately classify the new IVD to determine the specific regulatory pathway. Clearly define its intended use to avoid any ambiguity.
Technical Documentation (Device Master File)
Prepare a comprehensive dossier detailing design and development records, manufacturing processes, QC procedures, and complete product specifications.
Performance Data
Submit robust analytical performance data (sensitivity, specificity, accuracy, precision) and clinical performance evaluation data proving real-world effectiveness.
Risk Management
Develop an ISO 14971-compliant risk management plan and report, outlining robust mitigation strategies.
QMS Documentation
Provide evidence of a rigorous Quality Management System, such as ISO 13485 certification.
CDSCO Expert Review
The CLA and subject matter experts thoroughly review the dossier, potentially requesting clarifications or facility audits.
Why Partner With Us?
Obtaining approvals for novel IVDs is notoriously complex. Our specialized team increases your chances of a successful, timely approval.
- Strategic pre-submission pathway planning
- Expert technical dossier compilation
- Optimization of analytical & clinical data presentation
- Direct CDSCO liaison & query management