New analysis reveals discrepancies in medical device registration data across borders

A new analysis from Pure Global highlights significant discrepancies in how medical device registration data is interpreted and used, challenging the assumption that public data files can accurately represent market conditions and device registrations across national borders. The report, "Medical Device Registration Verification 2026: What 15 National Public Data Files Actually Contain," reveals that raw row counts in these files can be misleading, often leading to incorrect compliance decisions and miscalculated market sizes.

According to the analysis, the "grain" or structure of data in these files varies widely, with different regulatory objects appearing in rows that look similar when viewed in a spreadsheet. This variability has serious implications for manufacturers, distributors, and investors who rely on these files for critical business decisions.

Ran Chen, Chief Technology Officer at Pure Global, emphasized the importance of understanding the "grain" of each file. "Row counts are records, not installed bases," he said. "Before anyone treats a public file as evidence, they have to name what one row actually is: a certificate, a catalog item, a decision record or a document crawl."

The study examines 15 national public data files from diverse jurisdictions, including Singapore, Malaysia, Indonesia, the UAE, Israel, Bangladesh, Brazil, Mexico, Argentina, Ecuador, the United States, the European Union, Australia, Canada, Korea, and Japan. It reveals that identical-looking metrics can describe very different regulatory objects. For instance, in Ecuador's ARCSA file, 254,292 rows represent only 23,198 distinct registration numbers, meaning about 11 catalog items per certificate.

Similarly, the Argentine ANMAT Helena bulletin contains 47,325 rows against 28,594 distinct registration numbers, while the Singapore HSA SMDR file lists 20,860 rows but excludes Class A devices entirely, placing them in a separate database.

The analysis also highlights significant gaps in column completeness. For example, risk classification is populated in only five of the ten files audited, and manufacturer country information is complete in only three jurisdictions. The UAE EDE file contains no registration numbers across its 4,740 rows.

Furthermore, the study points out that two commonly used databases, FDA 510(k) and EUDAMED, are often mistaken for live registers. The FDA 510(k) database, which holds 175,559 records, is actually a collection of clearance decisions accumulated over decades. EUDAMED, with 2.9 million device models, has an authorized representative name field filled for only 48.5% of entries.

To address these issues, the report outlines a nine-step verification sequence designed to prevent common misreadings. These steps include naming the unit being counted, identifying each file's grain, and ensuring that identity fields such as registration numbers are locked before matching.

"Misreading a public file can lead to real costs," noted Chen. "Due-diligence hours are wasted on chasing records that were never the right object, validly registered devices are treated as unregistered, and market sizes are overstated due to inflated row counts."

For companies seeking to navigate the complexities of global medical device registration, Pure Global offers flat annual rates for in-country representation, ranging from $1,000 for U.S. Agent appointments to $3,000 for higher-risk registrations, with a typical four-market bundle at $9,000 per year. The complete schedule is available on the Pure Global website.

The study joins Pure Global's Deep Research series, which includes recent reports on coronary stents, surgical robots, in-vitro diagnostics, orthopedic implants, and the ISO 10993-1:2025 transition. Pure Global also maintains free AI-powered regulatory databases and tools, including searchable registration data across major markets.

Pure Global is a global medical device regulatory consulting firm with 15+ offices across five continents, supporting medical device and IVD companies with global market access, registration strategy, and ongoing regulatory compliance.