Glossary
Market-access glossary.
26 terms used across GHMAP country intelligence, certification pathways, and reviewed briefs — grouped by the part of a market-access decision they belong to.
Definitions are general educational descriptions, not jurisdiction-specific regulatory, reimbursement, or legal conclusions.
Core platform concepts
The vocabulary GHMAP uses to describe how a market-access record is sourced, rated, and reviewed.
- Market access
- The process of organizing regulatory, reimbursement, payer, evidence, procurement, and launch-readiness questions for a healthcare product.
- Source status
- A label showing whether information is source required, to verify, reviewed, outdated, or example only.
- Confidence level
- A planning label based on source quality, recency, jurisdiction match, corroboration, and review status.
- Professional review
- Qualified expert review before market-access content is used for business planning.
- Evidence gap
- A missing or insufficient evidence item that may need review before planning decisions.
Regulatory
General descriptions of pathways, authorities, and submissions. None of these are jurisdiction-specific conclusions.
- Regulatory pathway
- A structured question set about how a product may be reviewed or authorized in a jurisdiction. Source required.
- CE Mark
- The conformity marking required for medical devices placed on the market in the European Economic Area. It demonstrates that a product meets EU safety, health, and environmental protection requirements.
- FDA 510(k)
- A premarket submission to the US Food and Drug Administration to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.
- ANVISA
- Brazil's National Health Surveillance Agency — the regulatory authority responsible for registering and overseeing medical devices in the Brazilian market.
- NMPA
- China's National Medical Products Administration — the authority responsible for medical device registration, approval, and post-market surveillance in China.
- HTA (Health Technology Assessment)
- A multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. Used by payers and governments to make coverage and reimbursement decisions.
- Regulatory Submission
- A formal package of documents submitted to a regulatory authority to request approval, clearance, or registration of a medical device or healthcare product.
- Notified Body
- An organisation designated by an EU member state to assess whether a product meets EU regulatory requirements before CE marking. Examples include TÜV SÜD and BSI Group.
Reimbursement and payers
How payment, coverage, and pricing questions are structured before a market-access decision is taken.
- Reimbursement pathway
- A structured question set about whether and how payment, coverage, or reimbursement may be considered. Source required.
- Payer structure
- The organization of payers, payment channels, and decision points in a market. To verify.
- DRG (Diagnosis-Related Group)
- A payment classification system used by hospitals and insurers. Medical devices that fit into existing DRG codes are typically easier to reimburse than those requiring new codes.
- Coverage Decision
- A formal determination by a payer or government authority about whether a healthcare technology or procedure will be funded within a benefit package.
- Pricing Dossier
- A submission document used in market access negotiations to justify the price of a medical technology, typically including clinical evidence, health economic data, and budget impact analyses.
Network and distribution
The roles and responsibilities that determine whether a product can actually reach a market.
- KOL (Key Opinion Leader)
- A respected clinician, researcher, or academic whose expertise and endorsement can influence adoption of medical technologies within a country or specialty.
- Distributor Readiness
- An assessment of whether a potential local distributor has the regulatory capacity, storage infrastructure, sales network, and post-market support capabilities needed to represent a product.
- Importer of Record
- The legal entity responsible for ensuring an imported medical device meets the destination country's regulatory requirements and bears liability for compliance.
- Local Representative
- A person or organisation established in a regulatory jurisdiction who acts on behalf of a foreign manufacturer and takes legal responsibility for regulatory compliance in that market.
Intelligence and data
How market context is estimated, scored, and kept traceable back to a dated source.
- Market Sizing
- An estimate of the total available revenue opportunity for a product category in a specific country or region, typically expressed as total market value and compound annual growth rate (CAGR).
- Opportunity Score
- A composite planning indicator used by GHMAP to summarise market attractiveness based on regulatory complexity, market size, growth trajectory, payer coverage, and distributor ecosystem maturity.
- Source Governance
- The systematic process of tracking, validating, dating, and reviewing information sources used to populate market access records — ensuring conclusions are traceable and auditable.
- Distributor Landscape
- An overview of the distribution ecosystem in a given country, including the number of active distributors, their specialisation by product category, regulatory capability, and typical commercial terms.
Reviewed launch planning
Turn glossary terms into a structured market-access question set.
GHMAP organizes source status, evidence gaps, review needs, and next actions for the markets you are evaluating.
Professional review is required before business use.