A headline market-size figure rarely answers a distributor’s first questions: which models can be supplied, who pays, who imports them and who supports the users? Start with those relationships, then assess demand using sources whose scope can be checked.
Follow the roles through the supply chain
| Role | What to establish |
|---|---|
| Legal manufacturer | The entity and model named on product labeling and relevant records. |
| Registration applicant / representative | The party named in the jurisdiction’s process; do not assume it also imports or distributes. |
| Importer | The party bringing devices into the market and its applicable responsibilities. |
| Distributor / reseller | The actual supply scope, territory and contract evidence. |
| Clinic, payer and user support | Who prescribes or provides access where relevant, who funds supply, and who handles training and complaints. |
Where to look for market evidence
| Source route | What it can and cannot show |
|---|---|
| Regulator records | Product identity and authorized scope; not proof of sales or exclusivity. |
| Official payer rules | Coverage criteria and conditions; not the number of reimbursed users without further data. |
| Public tenders and awards | Specified procurement scope and dates; an award is not evidence of all market demand. |
| Customs/trade records | Shipment evidence within a classification; codes may combine products and do not by themselves establish patient use. |
| Company filings | Dated reported business data; check segment, geography and accounting scope. |
| Retail and channel pages | Observed offers; not guaranteed stock, authorized status or realized sales. |
Make uncertainty useful
Attach a date, territory, model scope and relationship type to each entry. Keep verified facts, hypotheses and required follow-up separate. If a figure has no traceable methodology, do not use it to rank country opportunities or invent a compound growth rate.
The FDA import guidance provides a concrete U.S. example of differing manufacturer and importer duties. It should not be generalized into a complete global supply-chain rule. For a new territory, verify the local roles and documents before promising launch timing.
Original sources
Sources reviewed 18 October 2026. Model features and local access should be checked against the current instructions and market record.