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Support Programs

Explore support programs data inside Signal Blue for global medical device export planning. Use this page as a focused entry point linked to certifications, market guides, and execution workflows.

Government and industry support programs for exporters50

ADB Health Innovation Fund

ADB (Asian Development Bank)

The Asian Development Bank's Health Innovation Fund provides concessional financing and technical assistance for medical device companies deploying innovative health technologies across ADB's 49 member developing countries in Asia and the Pacific. The fund prioritizes solutions addressing universal health coverage gaps, particularly in primary care diagnostics, maternal health, and infectious disease management.

Eligibility

Medical device companies with solutions deployable in ADB developing member countries

Benefits

  • Concessional loans at 1-2% annual interest with 10-15 year repayment terms
  • Technical assistance grants up to $1M for feasibility studies and pilot deployments
  • Co-financing arrangements with ADB sovereign health sector loans to member governments
  • Health system strengthening project integration for sustainable device procurement pipelines
  • Access to ADB procurement opportunities in 49 developing member countries
  • Impact measurement and reporting framework support for ESG-aligned investors

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APEX-Brasil Health Sector Program

Brazilian Trade and Investment Promotion Agency

APEX-Brasil's health sector program assists foreign medical device companies entering the Brazilian market through market research, buyer matching, and trade mission coordination. Brazil is Latin America's largest healthcare market with annual medical device imports exceeding $5B. The program helps navigate ANVISA regulatory requirements and connects companies with Brazilian distributors and hospital chains.

Eligibility

Companies entering Brazilian health market

Funding: N/A (in-kind support)

Benefits

  • Brazilian medical device market research and competitive analysis reports
  • Buyer matching with Brazilian distributors, hospital chains, and GPOs
  • Trade mission coordination to major Brazilian healthcare hubs
  • ANVISA regulatory pathway guidance and local representative introduction
  • Hospitalar exhibition participation support and meeting arrangement

Related Market Guides

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Austrade Health Sector Support

Austrade (Australian Trade and Investment Commission)

Austrade's health sector support program assists international medical device companies in entering the Australian healthcare market and leveraging Australia as a clinical trial hub for the Asia-Pacific region. Australia's TGA regulatory pathway has mutual recognition with many jurisdictions, and its world-class clinical trial infrastructure makes it attractive for generating evidence accepted by FDA, CE, and PMDA.

Eligibility

International medical device companies targeting the Australian market or seeking clinical trial partnerships

Benefits

  • TGA regulatory pathway guidance with mutual recognition leverage for expedited approvals
  • Clinical trial site matching at 40+ Australian hospital research centers
  • R&D tax incentive advisory (up to 43.5% refundable tax offset for eligible R&D)
  • Introduction to Australian hospital group purchasing organizations
  • Market intelligence reports on Australian healthcare procurement trends
  • Landing pad program: 90-day soft landing with co-working space and mentoring in Melbourne/Sydney

Related Market Guides

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BIRAC India MedTech Program

Biotechnology Industry Research Assistance Council

BIRAC's MedTech support program provides R&D grants, incubation support, and regulatory assistance for companies developing medical devices for the Indian market. India's rapidly growing healthcare sector and government emphasis on "Make in India" for medical devices create substantial opportunities. The program supports both domestic and international companies contributing to India's medical device self-sufficiency goals.

Eligibility

Companies developing medical devices for Indian market

Funding: Up to INR 50 Lakhs

Benefits

  • R&D grants up to INR 50 Lakhs for medical device innovation projects
  • Incubation support at BIRAC-funded bioincubators across India
  • CDSCO regulatory assistance for Indian medical device registration
  • Clinical trial support at Indian hospital networks
  • Market access facilitation through government health program integration

Related Market Guides

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Busan Medical Technology Cluster

Busan Metropolitan City

Cluster support program operated by Busan Metropolitan City for medical technology companies in the Busan area. The program provides access to shared R&D facilities, industry networking events, and export support services. Busan is positioning itself as a major medtech hub in Korea with dedicated infrastructure and incentive programs for health technology companies.

Eligibility

Medtech companies in Busan area

Funding: Up to KRW 50M

Benefits

  • Access to shared R&D facilities and testing equipment
  • Industry networking events connecting local and international partners
  • Export support services including buyer matching and trade show participation
  • Startup incubation space and mentoring programs
  • Workforce training subsidies for specialized medtech skills
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Enterprise Singapore Market Entry Program

Enterprise Singapore

Market entry support program by Enterprise Singapore to attract innovative medical device companies to use Singapore as their ASEAN regional hub. Provides grants, tax incentives, and operational support for companies establishing regional headquarters, R&D centers, or distribution hubs in Singapore. Singapore's strategic location and HSA regulatory alignment with FDA/CE make it an ideal gateway to the $15B ASEAN healthcare market.

Eligibility

International companies planning to establish operations in Singapore for ASEAN market access

Benefits

  • Market Readiness Assistance (MRA) grant up to SGD 100K for market entry activities
  • Enterprise Development Grant (EDG) covering up to 70% of qualifying costs for capability upgrading
  • Pioneer Certificate tax incentive: 0% corporate tax for up to 15 years on qualifying income
  • HSA regulatory submission fast-track via ASEAN Medical Device Directive (AMDD) reference pathway
  • Access to Singapore's extensive network of FTAs covering 27 trading partners

Related Market Guides

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Featured Support Programs

KOTRA Export Voucher

KOTRA

Government-funded export support voucher program covering overseas marketing, certification consulting, translation, market research, and business matching for Korean SMEs. The program reimburses up to 70% of eligible costs, with annual applications opening each January. Over 5,000 companies benefited in 2024 alone.

Up to ₩100M (~$75K) in export support funding per company per yearChoose from 350+ certified service providers across 8 service categoriesCovers FDA/CE/NMPA certification consulting fees (up to ₩50M per certification)

KHIDI Global Healthcare Market Entry Support

KHIDI (Korea Health Industry Development Institute)

Specialized support program for Korean healthcare companies entering overseas markets, operated by the government-affiliated KHIDI institute. Provides end-to-end market entry assistance from regulatory pathway planning through post-market establishment, with dedicated country desks for the US, EU, China, Japan, and ASEAN markets.

Overseas regulatory consulting for FDA 510(k)/PMA, CE MDR, NMPA, and PMDA submissionsClinical trial and performance evaluation funding up to ₩200M per projectMEDICA/Arab Health/FIME/CMEF exhibition booth allocation and 1:1 buyer matching

KMDICA Exhibition Participation Support

KMDICA (Korea Medical Devices Industry Cooperative Association)

Annual support program helping Korean medical device companies participate in 10+ major international trade shows including MEDICA (Germany), Arab Health (UAE), FIME (USA), and CMEF (China). KMDICA organizes the Korea Pavilion at each event, providing turnkey booth setup and on-site coordination.

Korea Pavilion booth allocation at MEDICA, Arab Health, FIME, CMEF, and HospitalarPre-show buyer matching with 1:1 scheduled meetings (average 8-12 meetings per exhibitor)On-site logistics coordination including booth design, shipping, and equipment rental

KOSME SME Export Support

KOSME (Korea SMEs & Startups Agency)

Comprehensive export assistance for Korean SMEs including overseas market development funds, export incubation, and policy-rate export loans. KOSME is one of the largest government agencies dedicated to SME growth, with an annual budget exceeding ₩3T. Medical device startups with less than 7 years of export history are prioritized under the incubation track.

Overseas market development funds up to ₩100M with 3-year repayment grace periodExport incubation program: 12-month mentoring from industry experts + seed fundingPolicy-rate export loans at 2.0-2.5% annual interest (vs. 4-5% market rate)

K-SURE Export Insurance

K-SURE (Korea Trade Insurance Corporation)

Export credit insurance protecting Korean exporters against overseas buyer default, political risks, and exchange rate fluctuations. Essential for medical device companies entering new markets with unfamiliar hospital procurement buyers. K-SURE covers 90-100% of insured losses, with premium rates as low as 0.1-0.5% of the insured amount for SMEs.

Short-term export credit insurance covering 90-100% of buyer default lossesMedium/long-term export credit insurance for capital goods (medical equipment) with up to 5-year coverageExchange rate risk coverage protecting margins from KRW/USD volatility

MFDS Overseas Regulatory Support

MFDS (Ministry of Food and Drug Safety)

Korean FDA (MFDS) provides direct support for domestic medical device companies seeking overseas regulatory approvals. The program includes regulatory pathway guidance, documentation review, and active participation in international harmonization efforts through IMDRF. Particularly valuable for Class II and III device manufacturers navigating complex multi-country approval strategies.

Overseas regulatory pathway mapping for FDA, CE MDR, NMPA, PMDA, and TGATechnical documentation review and gap analysis feedback within 4-6 weeksMutual Recognition Agreement (MRA) leverage for expedited approvals in partner countries

Explore all 50 support programs →

Frequently Asked Questions

What certifications are needed to export medical devices?

Requirements vary by market. Key certifications include FDA 510(k) for the US, CE marking under MDR 2017/745 for the EU, MDSAP for Canada, Australia, Brazil, and Japan, and country-specific approvals like PMDA, NMPA, and MFDS.

How long does the certification process typically take?

Timelines vary significantly: FDA 510(k) often takes 3 to 12 months, CE marking 6 to 12 months, and many emerging markets 6 to 24 months depending on testing, local representation, and submission quality.

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