Registry Insights · INVIMA

Colombia Medical Device Registry Statistics

Aggregated from 50,436 official INVIMA registration records. Data as of 2026-08-05.

The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) regulates medical devices in Colombia. As of 2026-08-05, this registry snapshot contains 50,436 registration records, of which 49,260 are currently active and 1,176 are cancelled, expired, or withdrawn.

The registry lists 5,986 distinct registration holders.

Every figure on this page is computed from the official registry snapshot. Browse individual records in the searchable Colombia device database, or see our methodology for how the data is collected.

49,260
Active registrations
5,986
Registration Holders
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Registrations by Risk Class

INVIMA risk classification of active registrations
Risk classRegistrationsShare
Class II13,22126.8%
Class I12,17824.7%
Class IIa10,91222.2%
Class III5,30510.8%
Class IIb4,95610.1%

Registrations by Product Type

Largest product type groups among active registrations
Product TypeRegistrationsShare
Medical & Surgical Devices24,19349.1%
Diagnostic Reagents19,44939.5%
In Vitro Reagents5,53911.2%
Dental790.2%

Top 50 Registration Holders in Colombia

Local registration holders ranked by active registrations held. Foreign manufacturers register through a Colombia Registration Holder (CRH) that owns the INVIMA registration.
RankRegistration HolderRegistrations
#1
ANNAR DIAGNOSTICA IMPORT S.A.S.1,777
#2
ABBOTT LABORATORIES DE COLOMBIA S.A.S.1,409
#3
LIFE TECHNOLOGIES CORPORATION1,364
#4
SIEMENS HEALTHCARE S.A.S1,287
#5
ROCHE DIAGNOSTICS GMBH1,059
#6
QUIMIOLAB S.A.S858
#7
ROCHEM BIOCARE COLOMBIA S.A.S.784
#8
BECTON DICKINSON DE COLOMBIA LTDA.619
#9
LABCARE DE COLOMBIA LTDA.615
#10
LABTRONICS S.A.S.602
#11
BECTON DICKINSON DE COLOMBIA LTDA591
#12
ANNAR DIAGNOSTICA IMPORT S.A.S542
#13
MINDRAY MEDICAL COLOMBIA S.A.S.482
#14
BECKMAN COULTER COLOMBIA S.A.S.473
#15
SANITAS S.A.S433
#16
LUMIRA S.A.S433
#17
BIOSCIENCES SAS403
#18
ROCHE DIAGNOSTICS GMBH (FABRICANTE PRODUCTO TERMINADO)387
#19
BECKMAN COULTER COLOMBIA SAS384
#20
LABIN COLOMBIA S.A.S382
#21
ORTHO - CLINICAL DIAGNOSTICS COLOMBIA S.A.S375
#22
AM ASESORIA Y MANTENIMIENTO LTDA352
#23
THERMO FISHER SCIENTIFIC COLOMBIA S.A.S.348
#24
WERFEN COLOMBIA S.A.S322
#25
ANALISIS TECNICOS LTDA.304
#26
MEDTRONIC INC283
#27
LABCARE DE COLOMBIA S.A.S271
#28
MERCK S.A.251
#29
TIB MOLBIOL SYNTHESELABOR GMBH242
#30
BOSTON SCIENTIFIC CORPORATION241
#31
NIPRO MEDICAL CORPORATION239
#32
ILLUMINA COLOMBIA S.A.S.219
#33
HUMAN GESELLSCHAFT FÜR BIOCHEMICA UND DIAGNOSTICA MBH215
#34
ANALISIS TECNICOS LTDA214
#35
3M COLOMBIA S.A.173
#36
JOHNSON & JOHNSON MEDTECH COLOMBIA S.A.S.169
#37
GENCELL PHARMA SAS161
#38
JOHNSON & JOHNSON DE COLOMBIA S.A.161
#39
QUIMICOS Y REACTIVOS S.A.S- SIGLA QUIMIREL S.A.S160
#40
GENTECH S.A.S158
#41
PHADIA AB156
#42
ABBOTT RAPID DIAGNOSTICS COLOMBIA S.A.S153
#43
BIOLORE LTDA.151
#44
SYSMEX COLOMBIA SAS151
#45
DIRUI INDUSTRIAL CO., LTD146
#46
WERFEN COLOMBIA SAS145
#47
BIOMERIEUX SA136
#48
BIOLORE LTDA128
#49
GILMEDICA S.A.122
#50
GENPRODUCTS COMPANY SAS120

About this data: statistics are computed from the official Instituto Nacional de Vigilancia de Medicamentos y Alimentos registry as mirrored in the Pure Global database (50,436 records; page generated 2026-08-05). “Active” excludes cancelled, expired, and withdrawn records. Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. See methodology.

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