We provide comprehensive regulatory affairs and compliance solutions for Medical Device and IVD companies across India — assisting manufacturers, importers, authorized agents, distributors, and healthcare organisations in meeting CDSCO requirements efficiently.
Complete support for registration and licensing of medical devices under the Medical Device Rules, 2017 — including regulatory assessment, document review, dossier preparation, application submission, and follow-up with regulatory authorities.
Our specialists assist clients in obtaining regulatory approvals for In Vitro Diagnostic products, ensuring compliance with CDSCO requirements and facilitating smooth registration and licensing.
We support foreign manufacturers and their authorized Indian representatives in obtaining CDSCO import licenses for medical devices and IVD products intended for the Indian market.
We assist domestic manufacturers in obtaining the necessary licenses for manufacturing medical devices and IVD products in India, ensuring full compliance with applicable regulations.
We prepare and compile comprehensive technical documentation — device descriptions, intended use, risk classifications, quality certifications, performance data, labeling documents, and other required submissions.
We manage the complete online application process through the CDSCO portal — account creation, application submission, document uploads, query responses, and application tracking.
Strategic guidance to help you understand regulatory pathways, classification requirements, approval timelines, documentation expectations, and compliance obligations.
Our experts evaluate existing technical documentation and quality systems to identify compliance gaps and recommend corrective actions before submission.
Ongoing support after approval — license amendments, product additions, renewals, compliance updates, and regulatory maintenance activities.
We assist overseas manufacturers in fulfilling regulatory requirements through coordination and support for Authorized Indian Agent-related documentation and submissions.
We review product labels, Instructions for Use (IFU), packaging artwork, and supporting documentation to ensure compliance with CDSCO guidelines and applicable regulations.
Professional support in responding to CDSCO observations, deficiency letters, and regulatory queries to facilitate timely approvals.
Our regulatory experts are ready to support your Medical Device and IVD approval journey across India.