IVD Device Compliance & Licensing in India

Analysers & Instruments

Reagents & Diagnostic Kits

Drug of Abuse Test Kits

Automated clinical chemistry analysers, immunoassay readers, hematology systems, and point-of-care diagnostic instrumentation.

Assay reagents, calibrators, control materials, and enzyme-linked immunosorbent assay (ELISA) test packages.

Toxicology testing panels, rapid substance screening strips, and confirmatory assay reagents meeting stringent regulatory thresholds.

IVD Software (SaMD)

Specimen Receptacles

Molecular Diagnostics

Standalone diagnostic algorithms, cloud-connected analytical platforms, and machine learning interpretation software for lab results.

Vacuum blood collection tubes, viral transport media, sterile swabs, and specialized bio-specimen containment vessels.

Real-time PCR test kits, next-generation sequencing assays, and nucleic acid extraction reagents for infectious disease testing.

Our IVD Compliance Services

Classification & Grouping Strategy

Performance Evaluation & Protocol

Dossier Compilation & Submission

Import & Manufacturing Licensing

Determine precise risk categorization (Class A to D) and construct optimized product grouping families to minimize registration costs.

Design testing protocols and coordinate analytical and clinical validation with CDSCO-notified laboratories across India.

Author comprehensive Device Master Files (DMF) and Quality Management System documentation for SUGAM portal filing.

Secure Form MD-14 import licenses or Form MD-9 manufacturing grants alongside post-market surveillance compliance.

Navigating CDSCO Medical Device Rules for IVDs

In Vitro Diagnostic products in India are regulated under Medical Device Rules (MDR) 2017. Depending on the intended diagnostic use and risk potential—ranging from low-risk Class A specimen containers to high-risk Class D blood-screening assays—CDSCO mandates specific clinical evidence, analytical performance evaluation reports, and ISO 13485 quality management conformity.

Artexa provides tailored compliance strategies for global medtech manufacturers and domestic producers. Our regulatory engineers ensure accurate risk mapping, leverage existing international predicate data to reduce local re-testing requirements, and oversee post-approval regulatory changes throughout the product life cycle.

Partner with Artexa's regulatory team for seamless CDSCO filings, laboratory coordination, and rapid approval management.