India Market Entry Assistance
India Market Entry Support for Medical Devices – Strategy to Post-Market Planning
Market Analysis
We provide in-depth analysis of India’s healthcare and MedTech ecosystem, identifying opportunities, market size, competitive landscape, and reimbursement frameworks. Our research spans across:
- Public and private hospital segments
- State-wise procurement policies
- Emerging therapeutic areas
- Pricing benchmarks and product positioning
This data empowers decision-makers to assess feasibility, shape strategy, and allocate resources effectively.
Demand & Supply Gap Assessment
India’s fragmented healthcare delivery often creates demand-supply mismatches across product categories. We analyze distribution inefficiencies, regional availability of devices, patient access trends, and diagnostic infrastructure. This helps companies:
- Prioritize SKUs for launch
- Choose between direct or third-party distribution
- Identify underserved markets with high potential
Our assessments are particularly useful for devices like surgical dressings, IVD kits, diagnostic imaging, and therapeutic wearables.
Strategy Formulation
We help define the optimal India entry strategy—whether greenfield, brownfield, or partnership-based. This includes:
- Regulatory & pricing roadmaps
- Localization opportunities
- Reimbursement & tender participation strategy
- Engagement with government and private sector stakeholders
Each plan is tailored to the client's product lifecycle stage and risk appetite.
Entity Formation
For companies seeking to establish a legal presence in India, we facilitate:
- Business structure evaluation (Pvt Ltd, LLP, WOS)
- Company incorporation under Ministry of Corporate Affairs
- PAN/TAN, GST, IEC registrations
- Opening of local bank accounts
- Strategic planning for compliance with Indian tax and FDI laws
We ensure legal setup aligns with future CDSCO licensing and operational needs.
Construction of Manufacturing Unit
For companies planning to manufacture or assemble in India under Make-in-India or PLI schemes, we provide:
- Site selection based on zoning, utilities, and logistics
- Factory layout and cleanroom design (ISO 13485, GMP compliant)
- AHU/BMS/HVAC engineering
- Coordination with EPC, statutory bodies, and state development authorities
- Project management up to validation and CDSCO licensing
This enables clients to operationalize a compliant facility within accelerated timelines.
Connecting Reliable Sales Channels
India’s distribution landscape can be opaque and highly localized. We help identify, vet, and engage reliable:
- Hospital procurement agents
- Device distributors and wholesalers
- Online & offline B2B resellers
- Tender aggregators for government contracts
We facilitate negotiations and onboarding with performance metrics and compliance support.
Ongoing Regulatory, Quality & Operational Support
Beyond entry, we provide retained support for:
- CDSCO licensing (MD-14, MD-15, MD-42)
- ISO 13485 and other QMS implementations
- Regulatory renewals and vigilance reporting
- Supply chain mapping and inventory optimization
Local HR recruitment and vendor identification
This ensures sustainable operations post-launch without compromising compliance or growth.
Mergers & Acquisitions (M&A) Advisory
We offer M&A advisory services for companies looking to:
- Acquire Indian manufacturers or distributors
- License technology to Indian partners
- Enter joint ventures or OEM partnerships
Our support spans legal due diligence, IP valuation, cultural fit analysis, and post-merger integration guidance—all within the Indian regulatory and business environment.
Data Analysis
We deliver end-to-end statistical data analysis aligned with the pre-approved statistical analysis plan (SAP). From primary endpoint evaluation to subgroup analysis, our services ensure that your study outcomes are scientifically defensible and suitable for regulatory review.
Clinical Evaluation Report (CER)
We prepare detailed Clinical Evaluation Reports in accordance with MEDDEV 2.7.1 Rev. 4 and EU MDR requirements. Our CERs integrate data from clinical investigations, literature reviews, and post-market surveillance to support CE marking and global regulatory submissions.
Post-Market Study (PMS)
We support the design and execution of post-market clinical follow-up (PMCF) and surveillance studies. These activities help generate real-world evidence on long-term safety, effectiveness, and device usability—critical for regulatory compliance and ongoing risk management.