Your Innovation. India's Market. We Bridge the Gap.

Market Strategy

Based on research outcomes, IBH presents two go-to-market pathways:

• Distributor-led marketing Products marketed through IBH-managed distributor network.
• Make in India pathway Where the oem product qualifies, IBH facilitates local manufacturing partnerships. This pathway triggers a separate regulatory and commercialisation track with additional benefits under the pli and make in India schemes.
  Government tenders are a key opportunity under the make in india pathway for global companies. IBH supports tender identification, documentation and submission in this model.

Regulatory Approvals

• CDSCO import submission IBH regulatory team prepares and submits the import licence application to cdsco. For medical devices, this includes form md-14/15 under MDR 2017, technical dossiers, test reports, and coc.
• Make in India approval (parallel) If path B is activated, a separate cdsco approval is obtained for the local manufacturing arrangement. IBH coordinates with the manufacturing partner on plant approvals, qms compliance, and product registration.
• DCGI approval received Upon grant of import licence / dcgi approval, IBH notifies the oem and activates the logistics chain for product release from FTZ.

Logistics & FTZ Warehousing

• OEM ships to IBH FTZ warehouse Before the import licence is granted, OEM ships product to IBH's Free Trade Zone (FTZ) warehouse. This pre-positioning strategy eliminates delay between licence grant and market availability.
• India-specific relabelling in FTZ Immediately on licence receipt, India-specific relabelling (language, importer details, CDSCO licence number, shelf life) is completed within the Ftz — without incurring import duties — and product is exported to Indian territory.
• Continuous FTZ inventory IBH maintains rolling inventory at the FTZ warehouse. Products are released to India on a demand basis, ensuring continuous availability without over-importation or duty exposure.

Import Clearance & Distribution

• Import clearance support IBH manages customs clearance, Bill of Entry filing, and condition-specific transport (temperature-controlled, controlled environment where required) to IBH's Indian storage facility.
• Distributor dispatch Products are dispatched from IBH's Indian facility to authorised distributors under validated cold chain / ambient conditions as per product specifications. Each distributor receives shipments based on order triggers.
• Market / Hospital delivery Distributors deliver to hospitals, clinics, diagnostic labs, or direct institutional buyers. Product reaches the end user with full traceability maintained through the IBH supply chain system.

Post-Market Support & Materiovigilance

• Customer care support IBH customer care team provides helpdesk support to end users — hospitals, clinical staff, procurement teams. Issues are logged, triaged, and escalated to field teams or OEM technical teams as needed.
• Field clinical engineer deployment For technical faults, IBH deploys Field Clinical Engineers (FCEs) on-site to troubleshoot, repair, or replace equipment. FCEs are trained on OEM product specifications and service manuals.
• Materiovigilance — ade/sade reporting IBH serves as the Authorised Indian Representative (AIR) / importer responsible for materiovigilance. Adverse Device Events (ADEs) and Serious ADEs (SADEs) are reported to CDSCO as required under MDR 2017 and the Medical Device Materiovigilance Programme of India (MvPI).
• Product recall management In the event of a quality or safety alert, IBH executes field recalls through its distributor network with full traceability. Recall notifications are submitted to CDSCO and coordinated with OEM in real time.