Is there enough product-specific demand?
Full Country Intelligence
Should you enter this country with this product?
GHMAP researches one healthcare or MedTech product in one target country and turns the evidence into a defensible market-entry decision.ONE PRODUCT · ONE COUNTRY · 15 BUSINESS DAYS · $5,000
Evidence-cited research. Transparent assumptions. Human-reviewed conclusions.
Before you invest in market entry, answer the questions that matter.
A large healthcare market does not automatically mean a good market for your product.
GHMAP evaluates the opportunity around your specific product, intended use, competitive position, regulatory pathway, payment environment and purchasing structure.
Can we compete at realistic market prices?
Can the product enter and get paid for?
Who buys it, and how do they buy?
The result is not another generic country report. It is evidence for a specific country-entry decision.
Four Intelligence Modules
MODULE 01
Market Opportunity
Is there enough demand for this product?
GHMAP analyzes the relevant patient, procedure, utilization and care-setting drivers; estimates annual unit demand; and develops transparent TAM and SAM ranges where the evidence supports them.
Outputs: Demand metrics · Unit-demand range · TAM/SAM · Market-value range · Growth direction · Opportunity drivers · Constraints
MODULE 02
Competitor & Pricing
What will this product compete against—and at what observable prices?
GHMAP maps relevant product-level competitors, compares technologies and positioning, and separates verified price observations by price type.
Outputs: Competitor universe · Five direct profiles · Product comparison · Pricing evidence · Positioning · Domestic/imported structure
List price, tender price, hospital price and reimbursement are never treated as the same thing.
MODULE 03
Regulatory & Reimbursement
Can the product enter the market, and how is care paid for?
GHMAP identifies the likely regulatory pathway and product requirements, then separately assesses whether reimbursement or another payment mechanism matters to adoption.
Outputs: Authority · Provisional classification · Registration pathway · Requirements · Fees · Timelines · Coverage · Coding · Payment · HTA
Regulatory intelligence is decision support—not a submission or approval guarantee.
MODULE 04
Buyer & Procurement
Who buys this type of product, and how is it purchased?
GHMAP maps the economic buyer, clinical user, technical evaluator and procurement structure, including important organizations and relevant public procurement evidence.
Outputs: Buyer ecosystem · Up to 15 organizations · Buyer concentration · Public/private pathways · Procurement models · Up to five recent tenders or awards
Named organizations are included for market structure—not as sales leads.
A decision package your team can review, challenge and act on.
Deliverable 1
Full Country Intelligence Decision Report
Executive assessment covering the market opportunity, competitive environment, regulatory and reimbursement pathway, buyers, procurement, risks and recommended next actions.
Deliverable 2
Evidence & Calculations Workbook
Source register, calculation inputs, market-sizing model, pricing evidence, competitors, regulatory evidence, buyers and procurement data.
Deliverable 3
60-Minute Analyst Debrief
Review the conclusion, assumptions, evidence gaps and key implications with GHMAP.
Deliverable 4
One Consolidated Revision
One revision round for factual corrections, clarification and in-scope customer feedback.
Every engagement is scoped to one product + one country.
Sample preview
Imported Next-Generation Drug-Eluting Coronary Stent → India
Hypothetical product · Real India evidence · Illustrative GHMAP customer deliverable
Research cutoff: August 19, 2026. Example only.
Decision
CONDITIONAL GO
- Overall evidence confidence
- MEDIUM
- Cath-lab capacity represented by five leading states
- 79.06%
Key metrics
- Observed PCI procedures — 2024
- 726,715
- Scenario TAM — DES units
- 832,942–1,068,381
- Scenario SAM — units
- 499,765–908,124
Pricing example
- Current NPPA DES ceiling
- ₹39,186.03 excluding GST
- Public patient-price observation example
- ₹23,625
- Premium public observations
- approximately ₹41,145
- Hospital acquisition price
- Not publicly verifiable
Regulatory path
- Foreign Manufacturer
- Indian Authorized Agent
- MD-14 Application
- CDSCO Review
- MD-15 Import Licence
Provisional Class D pathway — product-specific confirmation required.
Critical unknown
Confidential hospital acquisition pricing was not publicly verifiable.
Impact: Launch-margin assumptions should not be finalized until pricing is validated.
This sample is illustrative. It is not a regulatory, reimbursement, procurement, or market-entry conclusion for any real product.
Evidence you can trace. Uncertainty you can see.
GHMAP does not treat every internet result as evidence.
Research begins with the product definition and target country, then prioritizes primary regulatory, government, payer, procurement and statistical sources.
Official sources first
Regulators, ministries, public payers, HTA bodies, procurement systems and official statistics are prioritized.
Material claims are cited
Decision-relevant market, pricing, regulatory, reimbursement and procurement findings are connected to supporting sources.
Facts and assumptions stay separate
Source data, GHMAP assumptions and calculations are shown separately.
Calculations are reproducible
Market-sizing ranges show their inputs and methodology rather than presenting unexplained market numbers.
Uncertainty is disclosed
Material findings are labeled High, Medium, Low or Not Publicly Verifiable.
Human QA is required
AI may assist discovery, extraction, comparison and drafting. AI is not treated as evidence. Material conclusions receive human review.
The research ends with a decision—not a pile of data.
GO
Evidence supports moving to the next market-entry stage.
CONDITIONAL GO
The opportunity supports continued entry work, but defined conditions should be resolved before significant investment.
HOLD — EVIDENCE GAP
Critical information is not sufficiently verifiable to support a responsible entry decision yet.
NO-GO AT PRESENT
Current evidence does not justify proceeding under the assessed conditions.
No conclusion guarantees regulatory approval, reimbursement, procurement access, sales or commercial success.
FIXED-SCOPE ENGAGEMENT
Full Country Intelligence
$5,000
- Scope
- ONE PRODUCT
ONE COUNTRY - Timeline
- 15 BUSINESS DAYS
Included
- Full Country Intelligence Decision Report
- Evidence & Calculations Workbook
- 60-minute analyst debrief
- One consolidated revision round
Built for companies evaluating a real international market-entry decision.
Full Country Intelligence is designed for funded or revenue-generating MedTech and diagnostics companies evaluating whether to enter a specific international market with a defined product.
Typical users
- CEO / Founder
- VP International
- International Commercial Director
- Market Access Leader
- Business Development Leader
- Regulatory or Commercial Strategy Team
Best fit
- You have a defined product.
- You have a target country.
- You need evidence before allocating meaningful registration, distributor, commercial or launch resources.
Intelligence first. Execution is separate.
Full Country Intelligence supports the market-entry decision. It does not include:
- Distributor search or introductions
- KOL interviews
- Hospital outreach
- Buyer introductions
- Regulatory submission
- Reimbursement application
- Tender monitoring or submission
- Market-entry execution
GHMAP does not guarantee regulatory approval, reimbursement, market size, confidential transaction pricing, procurement access or sales.
Exploring a market before you have a product-specific question?
GHMAP also maintains public Country Intelligence profiles for general market exploration.
Public profiles provide country-level regulatory, reimbursement, healthcare-system, procurement and market context.
They are not a substitute for product-specific Full Country Intelligence.
EXPLORE A COUNTRY
Public Country Intelligence
- General country intelligence
- Public country profiles
- Source-tagged reference information
- No product-specific commercial conclusion
FULL COUNTRY INTELLIGENCE
Product-specific country-entry decision
- One specific healthcare product
- One target country
- Product-specific market, competitor, regulatory, reimbursement and procurement research
- Final country-entry decision
Public Country Intelligence
Ten-section country intelligence
Overview, market, regulatory, documents, market access, business intelligence, logistics, risks, AI recommendations, and Regulatory GPS — each figure shown with its source.
North America
Europe
FRFranceParis · ANSM (Agence nationale de sécurité du médicament et des produits de santé) — national competent authority. EU MDR applies; CE Mark via EU Notified Bodies (BSI, TÜV, DEKRA, SGS, etc.).
DEGermanyBerlin · No single national authority for EU MDR. Notified Bodies (BSI, TÜV SÜD, TÜV Rheinland, DEKRA) certify devices. BfArM (Federal Institute for Drugs and Medical Devices) handles vigilance and post-market surveillance.
ITItalyRome · ISS (Istituto Superiore di Sanità) and Ministero della Salute for national competent authority functions. EU MDR applies; CE Mark via EU Notified Bodies. AIFA for pharmaceutical-adjacent combination products.
NLNetherlandsAmsterdam · IGJ (Health and Youth Care Inspectorate) is the competent authority; CIBG/Farmatec handles EUDAMED economic-operator registration and NOTIS national notifications.
NONorwayOslo · Norwegian Medicines Agency (NOMA / Legemiddelverket) under the Ministry of Health and Care Services oversees medical device evaluation, authorization, and post-market surveillance.
PLPolandWarsaw · URPL (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products) is the central regulatory authority for medical devices in Poland.
RURussiaMoscow · Roszdravnadzor (Federal Service for Surveillance in Healthcare), under the Ministry of Health, is the central authority for medical device registration, quality, and post-market surveillance.
ESSpainBarcelona · AEMPS (Agencia Española de Medicamentos y Productos Sanitarios — Spanish Agency for Medicines and Medical Devices) is the national competent authority under EU MDR/IVDR.
SESwedenStockholm · Läkemedelsverket (Swedish Medical Products Agency, MPA), under the Ministry of Health and Social Affairs, is the national competent authority for medical devices under EU MDR/IVDR.
CHSwitzerlandZurich · Swissmedic (Swiss Agency for Therapeutic Products) is the national regulatory authority for medical devices and pharmaceuticals; Switzerland is not an EU member but aligns closely with EU MDR/IVDR via a Mutual Recognition Agreement framework.
TRTurkeyIstanbul · TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency)
GBUnited KingdomLondon · MHRA (Medicines and Healthcare products Regulatory Agency)
Asia Pacific
CNChinaShanghai · NMPA (National Medical Products Administration) — formerly CFDA / SFDA
INIndiaMumbai · CDSCO (Central Drugs Standard Control Organisation) — under Ministry of Health & Family Welfare
IDIndonesiaJakarta · BPOM (Badan Pengawas Obat dan Makanan — National Agency of Drug and Food Control) regulates medical devices jointly with the Ministry of Health (Kemenkes) under the Permenkes (Ministerial Regulation) framework.
JPJapanTokyo · PMDA (Pharmaceuticals and Medical Devices Agency) + MHLW (Ministry of Health, Labour and Welfare)
PKPakistanKarachi · DRAP (Drug Regulatory Authority of Pakistan) regulates medical devices under the Medical Device Rules 2017 (effective 16 January 2018).
KRSouth KoreaSeoul · MFDS (Ministry of Food and Drug Safety)
THThailandBangkok · Thai FDA (Food and Drug Administration), specifically its Medical Device Control Division (MDCD), regulates medical devices under the Medical Device Act B.E. 2551 (2008) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019, effective 2021).
Latin America
ARArgentinaBuenos Aires · ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica — National Administration of Drugs, Foods and Medical Technology) regulates medical devices in Argentina.
BRBrazilRio de Janeiro · ANVISA (Agência Nacional de Vigilância Sanitária) — Medical Device Regulation
COColombiaBogotá · INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos — National Food and Drug Surveillance Institute) regulates medical devices in Colombia.
MXMexicoMexico City · COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios — Federal Commission for Protection against Sanitary Risk) regulates medical devices in Mexico.
Middle East
ILIsraelTel Aviv · AMAR (Medical Device Division of the Israeli Ministry of Health) regulates medical devices under the Medical Equipment Law (2012) and its associated Regulations for Medical Equipment Registration.
SASaudi ArabiaRiyadh · SFDA (Saudi Food & Drug Authority) — Medical Device Sector
AEUnited Arab EmiratesDubai · MOHAP (Ministry of Health and Prevention) — federal. DHA (Dubai Health Authority) for Dubai. DoH (Department of Health) Abu Dhabi. HAAD (historical Abu Dhabi authority — now DoH).
Africa
EGEgyptCairo · The Egyptian Drug Authority (EDA), through its Central Administration of Medical Devices, is the current regulatory body for medical devices in Egypt. (Some older market materials reference 'EGMDB' — this appears to be a legacy/informal name for the same registration function, now consolidated under EDA's Central Administration of Medical Devices.)
KEKenyaNairobi · The Pharmacy and Poisons Board (PPB), through its Department of Product Evaluation and Registration (DPER), regulates medical devices including in vitro diagnostics in Kenya; the Kenya Bureau of Standards (KEBS) handles standards conformity for certain product categories.
MLMaliBamako · The Direction de la Pharmacie et du Médicament (DPM — Directorate of Pharmacy and Medicine), under the Ministry of Health and Social Development (MSDS), serves as Mali's National Pharmaceutical Regulatory Authority (ANRP) function, covering both pharmaceuticals and, to a more limited degree, medical devices.
NGNigeriaLagos · NAFDAC (National Agency for Food and Drug Administration and Control) regulates medical devices in Nigeria, recently updated via the NAFDAC Medical Device and Related Products Regulations 2024.
ZASouth AfricaCape Town · SAHPRA (South African Health Products Regulatory Authority) regulates medical devices in South Africa.
FAQ
Frequently asked questions
What is Full Country Intelligence?
A product-specific assessment of one healthcare or MedTech product in one target country covering market opportunity, competitors and pricing, regulatory and reimbursement, and buyer and procurement intelligence.
Is this the same as GHMAP’s public country profiles?
No. Public profiles provide general country context. Full Country Intelligence researches your specific product and produces a country-entry decision supported by cited evidence.
How long does it take?
Standard delivery is 15 business days after complete intake and scope lock.
What does $5,000 cover?
One product, one country, the Decision Report, Evidence & Calculations Workbook, one 60-minute analyst debrief and one consolidated revision round.
Does GHMAP guarantee regulatory approval or reimbursement?
No. Regulatory and reimbursement findings are evidence-based intelligence for business planning. Approval and payment decisions remain with the relevant authorities and payers.
Does GHMAP provide exact market size?
GHMAP provides market estimates only when the available evidence supports a defensible calculation. Source data, assumptions and calculations are separated, and uncertainty is disclosed.
Do you provide confidential hospital prices?
Only if such evidence is legitimately available to the project. GHMAP does not invent or infer confidential transaction prices. When pricing cannot be verified, it is explicitly marked.
Can GHMAP then help execute market entry?
Full Country Intelligence identifies the logical next actions. Any separate execution service requires its own scope.
Full Country Intelligence
Make the country decision before making the country investment.
Tell GHMAP your product and target country. We will confirm the scope before research begins.
Start Full Country Intelligence
$5,000 · One product · One country · 15 business days
GHMAP country intelligence is reference material, not clinical decision support, legal advice, or a regulatory, reimbursement, or market-entry guarantee.