Registry Insights · ANVISA

Brazil Medical Device Registry Statistics

Name: Brazil Medical Device Registry Statistics
Creator: Pure Global
License: https://creativecommons.org/licenses/by/4.0/

Aggregated from 109,709 official ANVISA registration records covering 12,169 manufacturers from 69 countries. Data as of 2025-09-15.

109,709

Registrations

12,169

Manufacturers

4,096

Registration Holders

Origin countries

DJ Fang

MedTech Regulatory Expert

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Pricing

New registrations by year

201420152016201720182019202020212022202320242025

VerifiedANVISA · data as of 2025-09-15

Registrations by risk class

Class IIClass IClass IIIClass IV

VerifiedANVISA · data as of 2025-09-15

Registrations by Technical Category

Largest technical category groups among registrations

Technical Category	Registrations	Share
Surgical instruments	3,310	3.0%
Catheters	2,455	2.2%
Instrument Kit	2,255	2.1%
Cannulas	1,925	1.8%
Surgical Kit	1,808	1.6%
Buffers, Diluents And Other Solutions For Laboratory Analysis	1,798	1.6%
Dressing	1,308	1.2%
Combined Parameters In The Same Product - Class Ii	1,216	1.1%
Instrumental For Orthopedic Implant	1,169	1.1%
Surgical Apparel	1,147	1.0%
Masks	1,060	1.0%
Coronavirus	958	0.9%
Orthopedic Fixation Systems And Associated Devices	943	0.9%
Flask Or Material For Collection, Storage Or Transport Of Biological Samples	869	0.8%
Hospital Apparel	850	0.8%
Disposable Needles	825	0.8%
Probes	813	0.7%
Disposable Gloves	789	0.7%
Infusion Sets	768	0.7%
Needles	729	0.7%

Manufacturer Countries of Origin

Where devices registered in Brazil are manufactured (top 15)

#	Country	Registrations	Share
1	Brazil	30,619	27.9%
2	China	17,924	16.3%
3	United States	16,063	14.6%
4	Germany	8,534	7.8%
5	Italy	2,380	2.2%
6	France	2,120	1.9%
7	India	1,903	1.7%
8	South Korea	1,846	1.7%
9	Switzerland	1,650	1.5%
10	United Kingdom	1,454	1.3%
11	Japan	1,300	1.2%
12	Spain	1,018	0.9%
13	Pakistan	924	0.8%
14	Argentina	801	0.7%
15	Taiwan	782	0.7%

Top 50 Manufacturers in Brazil

Ranked by registrations. Company names are normalized; affiliated legal entities are listed separately, as registered.

Rank	Manufacturer	Origin	Registrations	Top categories
#1	ROCHE DIAGNOSTICS GMBH	Germany	828	Buffers, Diluents And Other Solutions For Laboratory Analysis Combined Parameters In The Same Product - Class Ii Troponin
#2	SIEMENS HEALTHCARE DIAGNOSTICS INC.	United States	453	Buffers, Diluents And Other Solutions For Laboratory Analysis Combined Parameters In The Same Product - Class Ii Albumin
#3	MARDEN MEDICAL LTDA	Brazil	362	Surgical Kit Instrument Kit Cannulas
#4	E-MED PRODUTOS MÉDICO-HOSPITALARES LTDA - ME	Brazil	317	Instrument Kit Catheters Endoscopic Instruments
#5	JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.	Brazil	315	Dental Prosthesis Components Dental Surgical Instruments Surgical Instrument For Dental Implants
#6	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	China	310	Buffers, Diluents And Other Solutions For Laboratory Analysis Lysis Solution Combined Parameters In The Same Product - Class Ii
#7	QUIBASA QUÍMICA BÁSICA LTDA	Brazil	264	Coronavirus Combined Parameters In The Same Product - Class Ii Buffers, Diluents And Other Solutions For Laboratory Analysis
#8	SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.	China	264	Antibody Anti-Extractable Nuclear Antigens (Ena) Buffers, Diluents And Other Solutions For Laboratory Analysis Antinuclear Antibody (Ana)
#9	MEDTRONIC, INC.	United States	261	Cannulas Catheters Surgical instruments
#10	ABBOTT GMBH	Germany	255	Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv) Combined Parameters In The Same Product - Class Ii Toxoplasma Gondii
#11	LABTEST DIAGNOSTICA S/A	Brazil	241	Buffers, Diluents And Other Solutions For Laboratory Analysis Combined Parameters In The Same Product - Class Ii C-Reactive Protein
#12	BIOSYSTEMS S.A.	Spain	235	Combined Parameters In The Same Product - Class Ii Total Protein Creatinine
#13	RICHARD WOLF GMBH	Germany	223	Surgical instruments Rigid Endoscope Trochars
#14	RAZEK EQUIPAMENTOS LTDA	Brazil	222	Surgical Kit Surgical instruments Surgical Burs
#15	AESCULAP AG	Germany	220	Surgical instruments Instrument Kit Trochars
#16	Eco Diagnostica Ltda	Brazil	195	Coronavirus Dengue Combined Parameters In The Same Product - Class Ii
#17	BIODINAMICA QUIMICA E FARMACEUTICA LTDA	Brazil	192	Light-Cured Composite Resin Material for Root Canal Disinfection and Obturation Dental Whitening Agents
#18	ABBOTT MEDICAL	United States	189	Cardiovascular Guide Wire Catheters Cardiovascular Prostheses
#19	Humanna Medical Ltda	Brazil	187	Surgical Kit Cannulas Disposable Blades
#20	BOSTON SCIENTIFIC CORPORATION - MARLBOROUGH	United States	185	Catheters Endoprosthesis (Vascular) Intravascular Guide Catheter
#21	KOLPLAST CI LTDA	Brazil	181	Flask Or Material For Collection, Storage Or Transport Of Biological Samples Colpocitology Kit Disposable Speculum
#22	COLOPLAST A/S	Denmark	179	Collection Bags Catheters Dressing
#23	VYTTRA DIAGNOSTICOS S.A.	Brazil	178	Buffers, Diluents And Other Solutions For Laboratory Analysis Combined Parameters In The Same Product - Class Ii Lysis Solution
#24	ORGENTEC DIAGNOSTIKA GMBH	Germany	177	Antibody Anti-Extractable Nuclear Antigens (Ena) Antibody For Celiac Disease Antinuclear Antibody (Ana)
#25	WINNER INDÚSTRIA DE DESCARTÁVEIS LTDA	Brazil	176	Surgical Drape Surgical Apparel Surgical Gown Set, Surgical Drape And Gauze Sponge
#26	CPMH - Comércio e Indústria de Produtos Médico-Hospitalares e Odontológicos LTDA.	Brazil	175	External Fixators Instrumental For Orthopedic Implant Surgical instruments
#27	3M DO BRASIL LTDA	Brazil	170	Limb Orthosis Dressing Light-Cured Composite Resin
#28	GOLD ANALISA DIAGNOSTICA LTDA	Brazil	170	Coronavirus GLYCATED HEMOGLOBIN (HbA1C) Dengue
#29	BECKMAN COULTER, INC.	United States	169	Buffers, Diluents And Other Solutions For Laboratory Analysis Combined Parameters In The Same Product - Class Ii Instrument for sample preparation and processing – pre-analytical phase
#30	KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDA	Brazil	166	Lysis Solution Combined Parameters In The Same Product - Class Ii Buffers, Diluents And Other Solutions For Laboratory Analysis
#31	COVIDIEN LLC	United States	160	Catheters Dressing Probes
#32	HANGZHOU ALLTEST BIOTECH CO. LTD	China	160	Drugs Of Abuse Panel Self-Test For Human Chorionic Gonadotropin (Hcg) Instrument intended for immunoassays
#33	WIENER LABORATORIOS S.A.I.C.	Argentina	158	Combined Parameters In The Same Product - Class Ii Instrument for analysis of general biochemistry, hormones, drugs or proteins Buffers, Diluents And Other Solutions For Laboratory Analysis
#34	GM DOS REIS INDUSTRIA E COMERCIO LTDA	Brazil	153	Instrumental For Orthopedic Implant Orthopedic Fixation Systems And Associated Devices Non-Bioabsorbable, Non-Sterile Orthopedic Bone Screw
#35	KARL STORZ SE & CO. KG	Germany	153	Trochars Surgical instruments Tubes
#36	KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA	Brazil	152	Combined Parameters In The Same Product - Class Iii Human Chorionic Gonadotropin (Hcg) Total Rubella Virus
#37	BOSTON SCIENTIFIC CORPORATION	United States	151	Catheters Urinary Stent Peripheral Angioplasty Balloon Catheter
#38	COOK INCORPORATED	United States	151	Catheters Cardiovascular Guide Wire Dilators
#39	ABBOTT IRELAND DIAGNOSTICS DIVISION	Ireland	148	Buffers, Diluents And Other Solutions For Laboratory Analysis Hepatitis B Virus Surface Antigen (Hbsag) Thyroid Stimulating Hormone (Tsh)
#40	IN VITRO DIAGNOSTICA LTDA	Brazil	145	Buffers, Diluents And Other Solutions For Laboratory Analysis GLYCATED HEMOGLOBIN (HbA1C) Coronavirus
#41	WAMA PRODUTOS PARA LABORATORIO LTDA	Brazil	145	Urine Test Strip Combined Parameters In The Same Product - Class Ii Coronavirus
#42	EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG	Germany	143	Chlamydia Buffers, Diluents And Other Solutions For Laboratory Analysis Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv)
#43	LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPP	Brazil	140	Combined Parameters In The Same Product - Class Ii Buffers, Diluents And Other Solutions For Laboratory Analysis GLYCATED HEMOGLOBIN (HbA1C)
#44	BHIO SUPPLY INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS S/A	Brazil	139	Surgical instruments Cannulas Trochars
#45	DIASORIN ITALIA S.P.A.	Italy	139	Buffers, Diluents And Other Solutions For Laboratory Analysis Herpes Virus (Hhv 4) - Epstein-Barr Virus (Ebv) Herpes Virus (Hhv 2)
#46	ORTHO PAUHER INDUSTRIA COMERCIO E DISTRIBUICOES LTDA	Brazil	139	Protectors Orthopedic Insole Limb Orthosis
#47	OSTEOMED S.A	Brazil	139	Instrumental For Orthopedic Implant Instrumental for Spine Implant Spinal Fusion Cages
#48	SIEMENS HEALTHCARE DIAGNOSTICS INC	United States	139	Buffers, Diluents And Other Solutions For Laboratory Analysis Combined Parameters In The Same Product - Class Ii Creatine Kinase Isoenzymes (Ckmb, Ckbb, Ckmm)
#49	SYNTHES GMBH (OBERDORF)	Switzerland	139	Orthopedic Fixation Systems And Associated Devices Surgical instruments Instrument Kit
#50	Vida Biotecnologia Ltda - ME	Brazil	136	Coronavirus Buffers, Diluents And Other Solutions For Laboratory Analysis Bilirubin

Top 50 Registration Holders in Brazil

Local registration holders ranked by registrations held. Foreign manufacturers cannot register directly with ANVISA — a Brazil Registration Holder (BRH) files and owns the registration on their behalf.

Rank	Registration Holder	Registrations	Manufacturers represented
#1	VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA	3,284	389
#2	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	1,690	73
#3	AUTO SUTURE DO BRASIL LTDA.	1,574	105
#4	ROCHE DIAGNÓSTICA BRASIL LTDA	1,547	50
#5	JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA	1,280	102
#6	ABBOTT LABORATORIOS DO BRASIL LTDA	1,196	58
#7	EMERGO BRAZIL IMPORT IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS HOSPITALARES LTDA	1,011	265
#8	STRYKER DO BRASIL LTDA	1,007	64
#9	PASSROD IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS PARA SAÚDE LTDA - ME	787	127
#10	BOSTON SCIENTIFIC DO BRASIL LTDA	724	49
#11	CIRURGICA FERNANDES - COMERCIO DE MATERIAIS CIRURGICOS E HOSPITALARES - SOCIEDADE LIMITADA	712	186
#12	LABORATORIOS B. BRAUN S/A	695	59
#13	ARGOSLAB DISTRIBUIDORA DE PRODUTOS PARA LABORATÓRIOS LTDA	666	78
#14	VYTTRA DIAGNOSTICOS S.A.	642	45
#15	ZIMMER BIOMET BRASIL LTDA	629	59
#16	BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA	597	29
#17	QR CONSULTING, IMPORTACAO E DISTRIBUICAO DE PRODUTOS MEDICOS LTDA	549	31
#18	JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.	541	19
#19	Smith & Nephew Comércio de Produtos Médicos Ltda.	527	41
#20	3M DO BRASIL LTDA	518	45
#21	MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA	504	67
#22	MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA	483	67
#23	ST. JUDE MEDICAL BRASIL LTDA.	454	25
#24	MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA.	417	15
#25	EUROIMMUN BRASIL MEDICINA DIAGNOSTICA LTDA	414	10
#26	ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA	402	14
#27	BIOSYS LTDA	378	23
#28	PHADIA DIAGNOSTICOS LTDA	376	32
#29	BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDA	365	81
#30	MARDEN MEDICAL LTDA	362	1
#31	E TAMUSSINO E CIA LTDA	358	20
#32	LABORLAB PRODUTOS PARA LABORATÓRIOS LTDA EPP	357	10
#33	MEDIX BRASIL LTDA	352	98
#34	BIO-RAD LABORATORIOS BRASIL LTDA	350	11
#35	CEI COMÉRCIO EXPORTAÇÃO E IMPORTAÇÃO DE MATERIAIS MÉDICOS LTDA	346	62
#36	ARTHREX DO BRASIL IMPORTACAO E COMERCIO DE EQUIPAMENTOS MÉDICOS LTDA	344	27
#37	DIASORIN LTDA	343	18
#38	BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.	337	35
#39	BARD BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA A SAÚDE LTDA.	332	28
#40	WERFEN MEDICAL LTDA	330	21
#41	E-MED PRODUTOS MÉDICO-HOSPITALARES LTDA - ME	326	7
#42	WINNER INDUSTRIA DE DESCARTAVEIS LTDA	326	15
#43	Enzytec Biotecnologia Ltda.	321	22
#44	IN VITRO DIAGNOSTICA LTDA	299	3
#45	LABTEST DIAGNOSTICA S/A	296	21
#46	QUIBASA - QUIMICA BASICA LTDA	294	15
#47	COLOPLAST DO BRASIL LTDA.	287	13
#48	DESCARPACK DESCARTAVEIS DO BRASIL LTDA	279	91
#49	CEDRS - GESTAO EMPRESARIAL LTDA	267	27
#50	BIOMOLECULAR TECHNOLOGY COMÉRCIO, IMPORTAÇÃO, EXPORTAÇÃO E DISTRIBUIÇÃO DE MATERIAIS MÉDICOS E LABORATORIAIS LTDA - EPP	266	24

Top 100 Registration Holders

Companies holding the most ANVISA registrations, all-time and by year.

Top 100 Manufacturers

Global manufacturers with the most ANVISA registrations, all-time and by year.

Medical Specialty Reports

Per-specialty rankings and trends: top manufacturers, registration holders, quarterly registration history, and most common products for 16 specialties.

About the data

What the ANVISA registry shows

The Agência Nacional de Vigilância Sanitária (ANVISA) regulates medical devices in Brazil. As of 2025-09-15, this registry snapshot contains 109,709 registration records. The largest manufacturer by registrations is ROCHE DIAGNOSTICS GMBH with 828 registrations. Brazil is the largest country of origin, accounting for 30,619 registrations (27.9%). The registry lists 4,096 distinct registration holders.

Every figure is computed from the official registry snapshot as mirrored in the Pure Global database. Company names are normalized for whitespace and case, but distinct legal entities of the same group are counted separately. Browse individual records in the searchable Brazil device database, or see our methodology for how the data is collected.

VerifiedAgência Nacional de Vigilância Sanitária · 109,709 records · generated 2026-08-05

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Registrations by Technical Category

Manufacturer Countries of Origin

Top 50 Manufacturers in Brazil

Top 50 Registration Holders in Brazil

Top 100 Registration Holders

Top 100 Manufacturers

Medical Specialty Reports

Anesthesiology

Cardiovascular

Dental

ENT

Gastro & Urology

General Surgery

General Hospital

Neurology

OB/GYN

Ophthalmic

Orthopedic

Physical Medicine

Radiology

Clinical Chemistry

Hematology

Immunology

What the ANVISA registry shows

More Brazil medical device resources