Argentina Medical Device Registry Statistics
Aggregated from 34,216 official ANMAT filing records. Data as of 2024-08-14.
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) regulates medical devices in Argentina. As of 2024-08-14, this registry snapshot contains 34,216 filing records.
The registry lists 1,197 distinct registration holders.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Argentina device database, or see our methodology for how the data is collected.
New Filings by Year
| Year | New filings |
|---|---|
| 2024 | 4,235 |
| 2023 | 5,847 |
| 2022 | 5,925 |
| 2021 | 6,252 |
| 2020 | 4,837 |
| 2019 | 3,619 |
| 2018 | 2,968 |
| 2017 | 533 |
Filings by Filing Type
| Filing Type | Filings | Share |
|---|---|---|
| Class I-II Registration | 8,857 | 25.9% |
| Revalidation of Registration I-II-III-IV | 6,711 | 19.6% |
| Class I-II Registration Modification | 5,549 | 16.2% |
| Registration modification (non-agile) Class III-IV | 2,656 | 7.8% |
| IVD Registration Group A and B | 2,515 | 7.4% |
| Registration Class III-IV | 1,879 | 5.5% |
| IVD Modification Group A and B | 1,804 | 5.3% |
| Modification of Agile Registration Class III-IV | 1,540 | 4.5% |
| Class I-II Registration Revalidation | 878 | 2.6% |
| Revalidation + Modification of Class I-II Registration | 742 | 2.2% |
| Agile modification of product registration for IVD diagnostics - Group C and D | 544 | 1.6% |
| Registration of products for IVD diagnostics - Group C and D | 373 | 1.1% |
| Non-agile modification of products for IVD diagnostics - Group C and D | 122 | 0.4% |
| Registration of Class I medical devices listed in Annex II | 45 | 0.1% |
Top 50 Registration Holders in Argentina
About this data: statistics are computed from the official Administración Nacional de Medicamentos, Alimentos y Tecnología Médica registry as mirrored in the Pure Global database (34,216 records, newest registration dated 2024-08-14; page generated 2026-08-05). Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.