Introduction: Assistance to Medical Device Clusters (AMD-CF) Scheme

India’s medical device sector is expanding rapidly — from diagnostic equipment to advanced implantable technologies. Yet, for many MSMEs and manufacturing clusters, access to world-class testing infrastructure and regulatory compliance remains a major barrier.
To address this, the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals & Fertilizers launched the Assistance to Medical Device Clusters for Common Facilities (AMD-CF) Scheme in May 2023.

The scheme aims to empower medical device manufacturing clusters by offering up to 70% government grant assistance (or ₹20 crore, whichever is less) to create testing labs, R&D centers, and shared infrastructure essential for quality compliance and global competitiveness.

About the AMD-CF Scheme

The Assistance to Medical Device Clusters (AMD-CF) Scheme is part of the umbrella program “Strengthening of Pharmaceutical Industry (SPI)”. It supports the creation of Common Facility Centres (CFCs) and Testing Laboratories (TF) within approved medical device clusters across India.

Key Components

1. Assistance for Common Facilities (CF):
Financial support for setting up shared infrastructure such as sterilization units, biocompatibility labs, R&D centers, and prototyping hubs.

2. Assistance for Testing Facilities (TF):
Grants to establish or upgrade Medical Device Testing Laboratories (MDTL) for compliance under the Medical Device Rules (MDR) 2017.

AMD-CF Funding Pattern & Financial Assistance

Finraja Consultancy assists in CFA preparation, DPR drafting, SPV structuring, and fund linkage to ensure clients meet the scheme’s financial eligibility while optimizing grant utilization.

AMD-CF Eligibility Criteria

1. For Common Facilities (CF):

• Minimum of 5 Medical Device manufacturing units must form a Special Purpose Vehicle (SPV).
• SPV members should hold at least 51% equity, and no single unit can own more than 40%.
• Combined net worth of SPV members must be equal to or greater than the total grant applied.
• SPV members must be independent legal entities with no related-party relationships.
• Existing clusters promoted by State Governments can also act as SPVs with an Executive Committee.

2. For Testing Facilities (TF):

• Eligible entities include Central or State Government institutions, private organizations, or R&D institutes (like IITs, NIPERs, or NABL-accredited labs).
• They must establish dedicated accounts for project funds and comply with MDR 2017 norms.

Comprehensive Financial Assessment (CFA) & DPR Support

Developing a compliant and bankable proposal under AMD-CF requires:

1. Detailed Project Report (DPR) including:

• • Market analysis, infrastructure plan, and gap assessment.
  • Projected cost structure, capital investment, and financing model.
  • Sustainability plan, O&M strategy, and revenue generation model.

2. CFA Report covering:

• • • Net worth evaluation of SPV members.
    • Ratio analysis (Debt–Equity / Internal contribution).
    • Grant utilization matrix aligned with PFMS guidelines.
    • Financial closure plan including possible dovetailing with MSME or State incentives.

SPV Formation & Governance Framework

Creating an SPV (Special Purpose Vehicle) is mandatory for cluster-led projects under AMD-CF.

SPV Key Highlights:

• Must be registered under the Companies Act, 2013 or Societies Registration Act, 1860.
• Should include cluster members, R&D representatives, and state officials.
• SPV must maintain a 30% contribution in proportion to grant utilization and ensure transparency in fund management through PFMS.

Finraja assists in:

• Drafting MoA & AoA aligned with scheme norms.
• Obtaining CA-certified net worth verification.
• Structuring SPV shareholding patterns & agreements.
• Coordinating with DoP-approved Project Management Agency (PMA) for DPR submission.

AMD-CF Timeline & Fund Release Schedule

Project Duration:

• Implementation period: 2 years
• Possible extension: 1 additional year (on SSC approval)

Fund Disbursement Pattern:

Finraja ensures PFMS-linked fund utilization certification and provides post-sanction compliance monitoring and audit readiness support.

Medical Device Testing Laboratory Grant (MDTL)

Under the Testing Facilities (TF) sub-scheme, institutions can get up to ₹5 crore or 70% of project cost for establishing accredited testing labs to certify Class A–D medical devices.

Eligible testing areas include:

• Biocompatibility & sterilization labs
• Electromagnetic compatibility (EMC) & radiation testing
• ESDM/PCB/sensor component testing
• NABL & AERB certified X-ray and diagnostic device labs

Expected Benefits of the AMD-CF Scheme

• Strengthens India’s medical device manufacturing ecosystem.
• Improves global regulatory compliance under MDR 2017.
• Reduces testing & validation costs for MSMEs.
• Encourages innovation and import substitution.
• Creates shared testing, sterilization, and logistics infrastructure.
• Boosts competitiveness and self-sufficiency under Atmanirbhar Bharat.

Why Choose Finraja Consultancy Pvt. Ltd.

At Finraja, we specialize in Subsidy Consulting, DPR Preparation, and CFA Structuring for MSMEs, pharma clusters, and med-tech innovators under Government of India schemes like AMD-CF, SPI, API-CF, and PMFME.

Our Key Services Include:

• Detailed Project Report (DPR) aligned with DoP templates.
• CFA & Financial Structuring with compliance to PFMS and GFR-2017.
• SPV & Cluster Registration Assistance.
• Project Monitoring, Fund Release Tracking & Utilization Certificates.
• End-to-end liaison with PMA / DoP / SSC for smooth approval.

Partner with Finraja Consultancy to maximize your grant eligibility and ensure 100% compliant project execution under the Assistance to Medical Device Clusters (AMD-CF) Scheme.

Conclusion

The AMD-CF Scheme is a transformative opportunity for India’s medical device manufacturers and cluster developers. With up to 70% financial assistance for establishing high-value testing and R&D infrastructure, it bridges the critical gap between innovation and market readiness.

However, navigating its eligibility, documentation, and financial structuring demands expert guidance — which is where Finraja Consultancy Pvt. Ltd. ensures success, from CFA to sanction.

Call us now: +91 9373114747 or visit: finraja.com/contact for quick assistance.