Fitch Solutions uses a wide definition of a medical device, similar to that used by the US FDA or EU EMA. In short, we define it as any piece of equipment or apparatus used to treat or diagnose an illness that comes into direct contact with the patient. Pharmaceuticals, IV diagnostics and laboratory equipment are not within the scope of our forecasts. We have estimated national markets at ex-factory prices for the historical period in current local and USD terms. We have calculated the markets using a trade-based approach, looking at imports, and then adding in domestic production, minus any exports. We have sourced import and export data from national customs authorities, as compiled by the International Trade Centre (ITC). We have estimated production data, considering factors such as the value of exports, taking into account re-exports, the known presence of local and multinational manufacturers, sales data when available, and officially published estimates of production, again when available.
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