Drug Device Combination Products

Comprehensive dossier preparation, testing oversight, and regulatory approvals across complex biological and chemical drug delivery systems.

Pre-Filled Syringes (PFS)

Autoinjector Syringes

Co-Packaged Systems

Complete CDSCO registration support for pre-filled glass and polymer syringes, including container closure integrity testing and drug compatibility verification.

Regulatory approvals for electromechanical and spring-driven autoinjectors, focusing on ISO 11608 human factors and force delivery parameters.

Compliance strategies for drug-eluting stents, transdermal delivery patches, and targeted drug-device combination delivery kits.

Services for Combination Products

PMOA Classification

Dossier Synthesis

SEC Panel Representation

Import & Manufacture Licensing

Evaluating the Primary Mode of Action to determine whether your combination product falls under the Drug Directorate or Medical Device Division of CDSCO.

Compiling unified technical files combining ISO 13485 QMS device requirements with Drug Master File (DMF) stability and safety documentation.

Presenting clinical safety data and device performance metrics before CDSCO Subject Expert Committees (SEC) for expedited review.

Securing Form MD-15 import licenses or Form MD-9 manufacturing permissions for seamless market entry across India.

Navigating Dual Directorate Approvals

Drug-device combination products present unique regulatory hurdles in India because they fall at the intersection of the Drugs and Cosmetics Act and Medical Devices Rules 2017. Determining whether the therapeutic effect or mechanical delivery constitutes the Primary Mode of Action (PMOA) dictates the lead review division within CDSCO.

Our regulatory team harmonizes device engineering data with pharmacological dossiers. We manage cross-directorate consultations, ensure compliance with essential principles of safety and performance, and align international technical files with specific Indian regulatory standards to eliminate approval delays.

Speak directly with our drug-device regulatory strategists to classify your product and map your CDSCO approval pathway.