Ecuador Medical Device Registry Statistics
Aggregated from 175,937 official ARCSA registration records covering 6,992 manufacturers from 71 countries. Data as of 2023-12-28.
The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) regulates medical devices in Ecuador. As of 2023-12-28, this registry snapshot contains 175,937 registration records.
The largest manufacturer by registrations is BIO SB, INC. with 4,088 registrations. United States is the largest country of origin, accounting for 44,489 registrations (25.3%). The registry lists 1,664 distinct authorized representatives.
Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Ecuador device database, or see our methodology for how the data is collected.
Registrations by Risk Class
| Risk class | Registrations | Share |
|---|---|---|
| Class III | 64,703 | 36.8% |
| Class II | 50,067 | 28.5% |
| Class I | 47,284 | 26.9% |
| Class IV | 11,119 | 6.3% |
New Registrations by Year
| Year | New registrations |
|---|---|
| 2023 | 8,527 |
| 2022 | 13,347 |
| 2021 | 22,568 |
| 2020 | 33,946 |
| 2019 | 20,642 |
| 2018 | 20,692 |
| 2017 | 6,793 |
| 2016 | 10,028 |
| 2015 | 9,355 |
| 2014 | 7,169 |
| 2013 | 7,887 |
| 2012 | 5,111 |
Registrations by Product Type
| Product Type | Registrations | Share |
|---|---|---|
| Invasive | 89,854 | 51.1% |
| In Vitro Diagnostic | 26,050 | 14.8% |
| Non-invasive | 12,740 | 7.2% |
| Active (powered) | 12,231 | 7.0% |
Manufacturer Countries of Origin
| # | Country | Registrations | Share |
|---|---|---|---|
| 1 | United States | 44,489 | 25.3% |
| 2 | Germany | 30,206 | 17.2% |
| 3 | China | 16,116 | 9.2% |
| 4 | Brazil | 10,118 | 5.8% |
| 5 | India | 8,326 | 4.7% |
| 6 | France | 6,366 | 3.6% |
| 7 | Italy | 5,639 | 3.2% |
| 8 | Spain | 5,379 | 3.1% |
| 9 | Switzerland | 4,548 | 2.6% |
| 10 | Pakistan | 4,358 | 2.5% |
| 11 | United Kingdom Of Great Britain | 4,124 | 2.3% |
| 12 | Turkey | 3,524 | 2.0% |
| 13 | South Korea | 3,351 | 1.9% |
| 14 | Ecuador | 3,022 | 1.7% |
| 15 | Mexico | 2,217 | 1.3% |
Top 50 Manufacturers in Ecuador
| Rank | Manufacturer | Origin | Registrations | Top categories |
|---|---|---|---|---|
#1 | BIO SB, INC. | United States | 4,088 | In Vitro Diagnostic |
#2 | WALDEMAR LINK GMBH & CO. KG | Germany | 2,548 | Invasive |
#3 | WELDON INSTRUMENTS | Pakistan | 1,799 | Invasive |
#4 | MEDACTA INTERNATIONAL SA | Swiss | 1,734 | Invasive |
#5 | INSTITUT STRAUMANN AG | Switzerland | 1,727 | Invasive |
#6 | ARTHREX INC | United States | 1,660 | Invasive Active (powered) Non-invasive |
#7 | SMITH & NEPHEW, INC. | United States | 1,591 | Invasive Active (powered) |
#8 | HEBUMEDICAL GMBH | Germany | 1,388 | Non-invasive Invasive |
#9 | TECHNO-MEDICAL OPTICS-CHIRUNGIE GMBH | Germany | 1,351 | Invasive |
#10 | M.I.TECH CO., LTD. | South Korea | 1,330 | Invasive |
#11 | SPIGGLE & THEIS MEDIZINTECHNIK GMBH | Germany | 1,276 | Invasive |
#12 | TORNIER S.A.S | France | 1,262 | Invasive |
#13 | MERIL HEALTHCARE PVT. LTD. | India | 1,224 | Invasive |
#14 | BIOMET ORTHOPEDICS | United States | 1,217 | Invasive Non-invasive |
#15 | VINCULA INDUSTRIA COMERCIO IMPORTACION Y EXPORTACION DE IMPLANTES S.A. | Brazil | 1,119 | Invasive |
#16 | JJGC INDUSTRIA E COMERCIO DE MATEIRIAIS DENTARIOS S.A. | Brazil | 1,114 | Invasive |
#17 | SMART ENTERPRISES | Pakistan | 1,097 | Invasive |
#18 | IMPLANTCAST GMBH | Germany | 1,048 | Invasive |
#19 | MEDESY Ltd. | Italy | 1,034 | Invasive Non-invasive |
#20 | AS MEDIZINTECHNIK GMBH | Germany | 999 | Invasive |
#21 | THOMPSON SURGICAL INSTRUMENTS, INC | United States | 998 | Invasive |
#22 | COOK INCORPORATED | United States | 988 | Invasive In Vitro Diagnostic Non-invasive |
#23 | ROCHE DIAGNOSTICS GMBH | Germany | 987 | In Vitro Diagnostic |
#24 | ORTOSINTESE INDUSTRIA E COMERCIO LTDA | Brazil | 984 | Invasive Non-invasive |
#25 | MOZO GRAU S.A. | Spain | 979 | Invasive |
#26 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | China | 949 | Active (powered) In Vitro Diagnostic |
#27 | ORTHO SELECT GMBH | Germany | 926 | Invasive |
#28 | NUVASIVE INC | United States | 917 | Invasive |
#29 | WORLD CLASS TECHNOLOGY CORPORATION | United States | 914 | Invasive |
#30 | STEMA MEDIZINTECHNIK GMBH | Germany | 912 | Invasive |
#31 | TEDAN SURGICAL INNOVATIONS, LLC | United States | 885 | Invasive |
#32 | AMERICAN EAGLE INSTRUMENTS INC. | United States | 868 | Invasive |
#33 | AGOMED MEDIZIN-TECHNIK GMBH | Germany | 856 | Invasive |
#34 | DOUBLE MEDICAL TECHNOLOGY INC. | China | 845 | Invasive |
#35 | NUVASIVE INC. | United States | 804 | Invasive |
#36 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. | Spain | 802 | Invasive Non-invasive Active (powered) |
#37 | MICROXPRESS – A DIVISION OF TULIP DIAGNOSTICS (P) LTD. | India | 802 | In Vitro Diagnostic |
#38 | REDA INSTRUMENTE GMBH | Germany | 788 | Invasive |
#39 | DKSORTHO & SHARMA PHARMACEUTICAL PVT. LTD. | India | 778 | Invasive |
#40 | ORTHOPEDIATRICS CORP. | United States | 747 | Invasive |
#41 | PARAGON 28, INC | United States | 742 | Invasive |
#42 | ALBERT HEISS GMBH & CO. KG | Germany | 741 | Invasive |
#43 | NARANG MEDICAL LIMITED | India | 721 | Invasive |
#44 | TEKNO-MEDICAL OPTIK-CHIRURGIE GMBH | Germany | 698 | Invasive |
#45 | SANATMETAL ORTHOPAEDIC AND TRAUMATOLOGY EQUIPMENT MANUFACTURING LTD | Hungary | 694 | Invasive |
#46 | MAST GROUP LTD | United Kingdom Of Great Britain | 673 | In Vitro Diagnostic |
#47 | BIONNOVATION BIOMEDICAL PRODUCTS LTDA. | Brazil | 646 | Invasive |
#48 | Spineway S.A.S. | France | 640 | Invasive |
#49 | JHS LABORATORIO QUIMICO LTDA | Brazil | 636 | |
#50 | MEDIMAX INTERNATIONAL | Pakistan | 636 | Invasive |
Top 50 Authorized Representatives in Ecuador
About this data: statistics are computed from the official Agencia Nacional de Regulación, Control y Vigilancia Sanitaria registry as mirrored in the Pure Global database (175,937 records, newest registration dated 2023-12-28; 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.