Novel Medical Device Approval Strategy

Comprehensive guidance for breakthrough devices lacking existing predicate or Indian standards.

Classification & Monographs

Pre-Submission & SEC Meetings

Ethics & Test Licensing

Official classification filing, medical device monograph mapping, and global standard benchmarking to establish CDSCO jurisdiction.

Strategic preparation and formal representation before the Subject Expert Committee (SEC) to defend safety and clinical efficacy.

Securing Form MD-12 Test Licenses for evaluation, clinical investigations, and Ethics Committee protocol approvals across Indian sites.

4-Step Regulatory Pathway to Market

Gap Analysis & Predicate Review

SEC Representation & Pre-Meeting

Test License & Clinical Trial

Final Import / Manufacturing License

Determining novel device status, identifying applicable ISO/IEC standards, and structuring preliminary clinical evidence dossiers.

Filing pre-submission requests and presenting clinical justification before the CDSCO Subject Expert Committee.

Obtaining Form MD-12 Test License, Institutional Ethics Committee approvals, and conducting required local clinical investigations.

Submitting complete clinical evaluation reports to secure final Form MD-14 or Form MD-9 commercial approvals.

Harmonizing International Standards for CDSCO

When standard Indian monographs do not exist for a novel technology, CDSCO evaluates compliance against recognized international frameworks including ISO 13485, IEC 60601, and ISO 14971 risk management principles.

Artexa bridges technical documentation gaps by creating custom regulatory dossiers, performance evaluation protocols, and post-market surveillance plans that satisfy central licensing authority criteria.

Engage our senior medtech regulatory consultants to build your CDSCO SEC defense and test license submission.