Why Public Medical Device Databases Fail Market Analysis

The core of the issue lies in the "grain" of the data. Because national authorities define a single row differently—ranging from a product catalog item or a procedure bulletin to an actual registration certificate—comparative analysis often fails. For example, Ecuador’s catastro contains over 250,000 rows but only 23,198 distinct registration numbers, while Canada’s MDALL lists roughly 4.3 device identifiers for every single license. These structural discrepancies mean that a simple name match or row count is an unreliable indicator of a product's legal status or market presence.

Pure Global’s analysis highlights that even major databases like the U.S. FDA 510(k) and EUDAMED are frequently misused. The 510(k) serves as a historical record of clearance decisions rather than a current product list, and EUDAMED’s authorized-representative field remains incomplete in over half of its entries. Ran Chen, Chief Technology Officer at Pure Global, emphasizes that teams must define the specific nature of a record before treating it as evidence. Failure to do so leads to significant operational costs, including wasted due-diligence hours, the misidentification of valid products as unregistered, and inaccurate market sizing that can derail international launches.