Market-access glossary.

26 terms · Definitions are general educational descriptions and not jurisdiction-specific regulatory or legal conclusions.

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A label showing whether information is source required, to verify, reviewed, outdated, or example only.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 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 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.

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.

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.