Registry Insights ยท Kemenkes

Indonesia Medical Device Registry Statistics

Aggregated from 67,600 official Kemenkes registration records covering 14,231 manufacturers from 70 countries. Data as of 2025-02-12.

The Ministry of Health of the Republic of Indonesia (Kemenkes) regulates medical devices in Indonesia. As of 2025-02-12, this registry snapshot contains 67,600 registration records.

The largest manufacturer by registrations is ROCHE DIAGNOSTICS GMBH. with 682 registrations. China is the largest country of origin, accounting for 21,848 registrations (32.3%). The registry lists 2,978 distinct authorized representatives.

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

67,600
Registrations
14,231
Manufacturers
2,978
Authorized Representatives
70
Origin countries
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Registrations by Risk Class

Kemenkes risk classification of registrations
Risk classRegistrationsShare
Class B30,35944.9%
Class A19,51628.9%
Class C15,24522.6%
Class D2,4793.7%

New Registrations by Year

Registrations issued per year
YearNew registrations
20252,275
202419,031
202317,316
202213,658
20219,077
20204,096
20192,044
2018103

Registrations by Product Type

Largest product type groups among registrations
Product TypeRegistrationsShare
Clinical Chemistry Test System7,62911.3%
Surgical Equipment6,6769.9%
Therapeutic General and Individual Hospital Equipment2,6543.9%
General Hospital Equipment and Other Individuals2,6123.9%
Therapeutic Anesthesia Equipment2,5153.7%
Diagnostic Radiology Equipment2,2543.3%
Serological Reagents2,1393.2%
Immunological Test System2,0413.0%
Prosthetic Physical Health Equipment1,7672.6%
Diagnostic Cardiology Equipment1,6862.5%
Therapeutic Eye Equipment1,6322.4%
Prosthetic Dental Equipment1,5712.3%
Prosthetic Orthopedic Equipment1,5272.3%
Therapeutic Physical Health Equipment1,5122.2%
Other Dental Equipment1,4312.1%
Surgical Dental Equipment1,4302.1%
Therapeutic Gastroenterology-Urology Equipment1,3612.0%
Hematological Reagents1,3111.9%
Monitoring Cardiology Equipment1,2981.9%
Products used in the manufacture of blood preparations and preparations of origin and blood1,2841.9%

Manufacturer Countries of Origin

Where devices registered in Indonesia are manufactured (top 15)
#CountryRegistrationsShare
1China21,84832.3%
2Germany8,51012.6%
3United States7,94811.8%
4South Korea3,9295.8%
5Japan2,5953.8%
6Italy2,1503.2%
7India2,0153.0%
8United Kingdom1,6422.4%
9Taiwan1,5572.3%
10France1,5162.2%
11Pakistan1,1811.7%
12Turkey1,1581.7%
13Spain1,1231.7%
14Switzerland1,0481.6%
15Malaysia8791.3%

Top 50 Manufacturers in Indonesia

Ranked by registrations. Company names are normalized; affiliated legal entities are listed separately, as registered.
RankManufacturerOriginRegistrationsTop categories
#1
ROCHE DIAGNOSTICS GMBH.Germany682
Clinical Chemistry Test System
Immunological Test System
Clinical Toxicology Test System
#2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTDChina436
Clinical Chemistry Test System
Diagnostic Radiology Equipment
Immunological Test System
#3
BIOSYSTEMS S.A.Spain302
Clinical Chemistry Test System
Immunological Test System
Haematology Package and Kit
#4
AESCULAP AG.Germany236
Surgical Equipment
Surgical Neurology Equipment
Surgical Obstetric and Gynaecological Equipment
#5
DIASYS DIAGNOSTIC SYSTEMS GMBH.Germany213
Clinical Chemistry Test System
Immunological Test System
Clinical Toxicology Test System
#6
ABBOTT IRELAND DIAGNOSTICS DIVISION.Ireland198
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#7
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.China193
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#8
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.China178
Clinical Chemistry Test System
Therapeutic Anesthesia Equipment
Diagnostic Radiology Equipment
#9
DIRUI INDUSTRIAL CO., LTD.China171
Clinical Chemistry Test System
Hematological Reagents
Reagents and Specimen Providers
#10
COVIDIENUnited States167
Surgical Equipment
Therapeutic Anesthesia Equipment
Diagnostic Gastroenterology-Urology Equipment
#11
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)United States166
Clinical Chemistry Test System
Immunological Test System
Hematological Reagents
#12
AS MEDIZINTECHNIK GMBHGermany150
Surgical Equipment
Surgical Obstetric and Gynaecological Equipment
Gastroenterology-Surgical Urology Equipment
#13
BOSTON SCIENTIFIC CORPORATIONCosta Rica146
Diagnostic Cardiology Equipment
Therapeutic Gastroenterology-Urology Equipment
Diagnostic Gastroenterology-Urology Equipment
#14
ACRO BIOTECH, INC.United States143
Clinical Toxicology Test System
Serological Reagents
Clinical Chemistry Test System
#15
DIALAB GMBH.Austria143
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#16
PATWAL SURGICAL CO.Pakistan141
Surgical Equipment
Surgical Dental Equipment
Surgical Obstetric and Gynaecological Equipment
#17
ABBOTT IRELAND DIAGNOSTICS DIVISIONIreland135
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#18
AS MEDIZINTECHNIK GMBH.Germany134
Surgical Equipment
Surgical Orthopaedic Equipment
Surgical Obstetric and Gynaecological Equipment
#19
HUMAN GESELLSCHAFT FรœR BIOCHEMICA UND DIAGNOSTICA MBHGermany134
Clinical Chemistry Test System
Serological Reagents
Immunological Test System
#20
ORTHO-CLINICAL DIAGNOSTICSUnited Kingdom132
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#21
URIT MEDICAL ELECTRONIC CO., LTDChina127
Clinical Chemistry Test System
Hematological Reagents
Clinical Laboratory Equipment
#22
ROCHE DIAGNOSTICS GMBHGermany117
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#23
BODITECH WITH INC.South Korea116
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#24
HANGZHOU ALLTEST BIOTECH CO., LTD.China115
Clinical Chemistry Test System
Serological Reagents
Clinical Toxicology Test System
#25
CELL MARQUE CORPORATIONUnited States114
Biological Dyes
Reagents and Specimen Providers
#26
TOSOH AIA INC.Japan109
Clinical Chemistry Test System
Immunological Test System
Hematological Reagents
#27
SIEMENS HEALTHCARE DIAGNOSTICS INC.United States108
Clinical Chemistry Test System
Immunological Test System
Hematological Reagents
#28
ZHONGSHAN CAMRY ELECTRONIC CO., LTD.China108
General and Individual Hospital Equipment Monitoring
Monitoring Cardiology Equipment
Diagnostic Orthopedic Equipment
#29
VARITEKS ORTHOPEDICS INDUSTRY INC.Turkey104
Prosthetic Physical Health Equipment
Therapeutic General and Individual Hospital Equipment
Therapeutic Gastroenterology-Urology Equipment
#30
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.China104
Clinical Toxicology Test System
Serological Reagents
Clinical Chemistry Test System
#31
GANSU CONSTAR TECHNOLOGY GROUP CO., LTD.China103
Therapeutic Eye Equipment
#32
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTDChina101
Monitoring Cardiology Equipment
Therapeutic General and Individual Hospital Equipment
Diagnostic Gastroenterology-Urology Equipment
#33
FRIMED MEDIZINTECHNIK GMBH.Germany98
Surgical Equipment
Surgical Obstetric and Gynaecological Equipment
Ear, Nose and Throat Surgical Equipment
#34
ERBA LACHEMA S.R.O.Czech Republic93
Clinical Chemistry Test System
Hematological Reagents
Automatic and Semi-Automatic Hematology Equipment
#35
OZON INSTRUMENTSPakistan92
Surgical Equipment
Surgical Dental Equipment
Surgical Obstetric and Gynaecological Equipment
#36
GUANGZHOU WONDFO BIOTECH CO., LTD.China91
Clinical Chemistry Test System
Clinical Toxicology Test System
Immunological Test System
#37
NOPA INSTRUMENTS MEDIZINTECHNIK GMBHGermany88
Ear, Nose and Throat Surgical Equipment
Surgical Equipment
Surgical Obstetric and Gynaecological Equipment
#38
MICROBIOLOGICS, INC.United States87
Microbiology Equipment
#39
KARL STORZ SE & CO., KG.Germany85
Diagnostic Gastroenterology-Urology Equipment
Gastroenterology-Surgical Urology Equipment
Surgical Equipment
#40
AMNOTEC INTERNATIONAL MEDICAL GMBHGermany83
Surgical Equipment
Diagnostic Gastroenterology-Urology Equipment
Gastroenterology-Surgical Urology Equipment
#41
JIANGSU YUYUE MEDICAL EQUIPMENT&SUPPLY CO., LTDChina83
Therapeutic Anesthesia Equipment
Diagnostic Cardiology Equipment
General and Individual Hospital Equipment Monitoring
#42
I-MING SANITARY MATERIALS CO., LTD.Taiwan81
Prosthetic Physical Health Equipment
Therapeutic General and Individual Hospital Equipment
General Hospital Equipment and Other Individuals
#43
SHENZHEN YHLO BIOTECH CO., LTDChina80
Immunological Test System
Clinical Chemistry Test System
Serological Reagents
#44
ACKERMANN INSTRUMENTE GMBH.Germany79
Surgical Equipment
Diagnostic Gastroenterology-Urology Equipment
Surgical Obstetric and Gynaecological Equipment
#45
RANDOX LABORATORIES LTD.United Kingdom79
Clinical Chemistry Test System
Immunological Test System
Serological Reagents
#46
ZYBIO INC.China79
Clinical Chemistry Test System
Hematological Reagents
Immunological Test System
#47
MERIL DIAGNOSTICS PVT., LTD.India76
Clinical Chemistry Test System
Serological Reagents
Immunological Test System
#48
THERMO FISHER SCIENTIFIC OY.Finland76
Clinical Chemistry Test System
Immunological Test System
Clinical Laboratory Equipment
#49
VENTANA MEDICAL SYSTEMS, INC.United States75
Biological Dyes
Pathology Equipment and Accessories
Reagents and Specimen Providers
#50
ZHANG PU ORTHOLIFE REHABILITATION CO., LTD.China74
Prosthetic Physical Health Equipment
Therapeutic Physical Health Equipment
General Hospital Equipment and Other Individuals

Top 50 Authorized Representatives in Indonesia

Local authorized representatives ranked by registrations held.
RankAuthorized RepresentativeRegistrationsManufacturers represented
#1
PT. ROCHE INDONESIA1,07483
#2
PT. ABBOTT PRODUCTS INDONESIA941128
#3
PT. MEDTRONIC INDONESIA786208
#4
PT. SIEMENS HEALTHINEERS INDONESIA703128
#5
PT. ENSEVAL MEDIKA PRIMA658157
#6
PT. MINDRAY MEDICAL INDONESIA64342
#7
PT. MEGA PRATAMA MEDICALINDO634133
#8
PT. TAWADA HEALTHCARE589179
#9
PT. FAITHFUL MEDICAL GRACE58170
#10
PT. INTIGLOBAL PERFECT RESULT SOURCE440101
#11
PT. EAST RAYA LESTARI42550
#12
PT. SYSMEX INDONESIA42267
#13
PT. IDS MEDICAL SYSTEMS INDONESIA419182
#14
PT. SURGIKA ALKESINDO384136
#15
MINDRAY MEDICAL INDONESIA37926
#16
SIEMENS HEALTHINEERS INDONESIA37377
#17
PT. GE OPERATIONS INDONESIA356101
#18
PT. DHH TRADING INDONESIA34077
#19
PT. B. BRAUN MEDICAL INDONESIA32167
#20
PT. THOMASONG NIRMALA31582
#21
PT. BECTON DICKINSON INDONESIA30889
#22
PT. MEDICAL ERA ALKESINDO307100
#23
JOHNSON AND JOHNSON INDONESIA TWO30486
#24
PT. SEKARGUNA MEDIKA30077
#25
PT. BINTANG SAUDARA SEMESTA JAYA29940
#26
PT. ENDO INDONESIA284119
#27
PT. ANDAMAN MEDICAL INDONESIA27986
#28
PT. FOCUS DIAGNOSTIC INDONESIA27845
#29
PT. TRANSMEDIC INDONESIA268102
#30
PT. BRIDGE TWO26776
#31
PT. PHILIPS INDONESIA COMMERCIAL25358
#32
PT. MURTI INDAH SENTOSA25270
#33
PT. MAGNIFICENT ALKESINDO25126
#34
PT. KARINDO ALKESTRON25054
#35
MEDTRONIC INDONESIA24988
#36
PT. SERENITY INDONESIA24772
#37
PT. LABORA MANDIRI INDO PRATAMA24570
#38
COBRA DENTAL INDONESIA23870
#39
PT. DJUNIAR & DJUNIAR236104
#40
PT. MURSMEDIC23468
#41
B. BRAUN MEDICAL INDONESIA21942
#42
PT. ELGA TAMA2186
#43
PT. CEKINDO BUSINESS INTERNATIONAL21553
#44
EMERALINDO ASIA PACIFIC20922
#45
PT. CIPTA VARIA KHARISMA UTAMA20928
#46
PT. FONDACO JAYATAMA20876
#47
PT. SUMIFIN CITRA ABADI20746
#48
PT. COBRA DENTAL INDONESIA20777
#49
PT. TERUMO INDONESIA20268
#50
MEGA PRATAMA MEDICALINDO20158

About this data: statistics are computed from the official Ministry of Health of the Republic of Indonesia registry as mirrored in the Pure Global database (67,600 records, newest registration dated 2025-02-12; 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.

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