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.

Registrations by Risk Class
| Risk class | Registrations | Share |
|---|---|---|
| Class B | 30,359 | 44.9% |
| Class A | 19,516 | 28.9% |
| Class C | 15,245 | 22.6% |
| Class D | 2,479 | 3.7% |
New Registrations by Year
| Year | New registrations |
|---|---|
| 2025 | 2,275 |
| 2024 | 19,031 |
| 2023 | 17,316 |
| 2022 | 13,658 |
| 2021 | 9,077 |
| 2020 | 4,096 |
| 2019 | 2,044 |
| 2018 | 103 |
Registrations by Product Type
| Product Type | Registrations | Share |
|---|---|---|
| Clinical Chemistry Test System | 7,629 | 11.3% |
| Surgical Equipment | 6,676 | 9.9% |
| Therapeutic General and Individual Hospital Equipment | 2,654 | 3.9% |
| General Hospital Equipment and Other Individuals | 2,612 | 3.9% |
| Therapeutic Anesthesia Equipment | 2,515 | 3.7% |
| Diagnostic Radiology Equipment | 2,254 | 3.3% |
| Serological Reagents | 2,139 | 3.2% |
| Immunological Test System | 2,041 | 3.0% |
| Prosthetic Physical Health Equipment | 1,767 | 2.6% |
| Diagnostic Cardiology Equipment | 1,686 | 2.5% |
| Therapeutic Eye Equipment | 1,632 | 2.4% |
| Prosthetic Dental Equipment | 1,571 | 2.3% |
| Prosthetic Orthopedic Equipment | 1,527 | 2.3% |
| Therapeutic Physical Health Equipment | 1,512 | 2.2% |
| Other Dental Equipment | 1,431 | 2.1% |
| Surgical Dental Equipment | 1,430 | 2.1% |
| Therapeutic Gastroenterology-Urology Equipment | 1,361 | 2.0% |
| Hematological Reagents | 1,311 | 1.9% |
| Monitoring Cardiology Equipment | 1,298 | 1.9% |
| Products used in the manufacture of blood preparations and preparations of origin and blood | 1,284 | 1.9% |
Manufacturer Countries of Origin
| # | Country | Registrations | Share |
|---|---|---|---|
| 1 | China | 21,848 | 32.3% |
| 2 | Germany | 8,510 | 12.6% |
| 3 | United States | 7,948 | 11.8% |
| 4 | South Korea | 3,929 | 5.8% |
| 5 | Japan | 2,595 | 3.8% |
| 6 | Italy | 2,150 | 3.2% |
| 7 | India | 2,015 | 3.0% |
| 8 | United Kingdom | 1,642 | 2.4% |
| 9 | Taiwan | 1,557 | 2.3% |
| 10 | France | 1,516 | 2.2% |
| 11 | Pakistan | 1,181 | 1.7% |
| 12 | Turkey | 1,158 | 1.7% |
| 13 | Spain | 1,123 | 1.7% |
| 14 | Switzerland | 1,048 | 1.6% |
| 15 | Malaysia | 879 | 1.3% |
Top 50 Manufacturers in Indonesia
| Rank | Manufacturer | Origin | Registrations | Top categories |
|---|---|---|---|---|
#1 | ROCHE DIAGNOSTICS GMBH. | Germany | 682 | Clinical Chemistry Test System Immunological Test System Clinical Toxicology Test System |
#2 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD | China | 436 | Clinical Chemistry Test System Diagnostic Radiology Equipment Immunological Test System |
#3 | BIOSYSTEMS S.A. | Spain | 302 | Clinical Chemistry Test System Immunological Test System Haematology Package and Kit |
#4 | AESCULAP AG. | Germany | 236 | Surgical Equipment Surgical Neurology Equipment Surgical Obstetric and Gynaecological Equipment |
#5 | DIASYS DIAGNOSTIC SYSTEMS GMBH. | Germany | 213 | Clinical Chemistry Test System Immunological Test System Clinical Toxicology Test System |
#6 | ABBOTT IRELAND DIAGNOSTICS DIVISION. | Ireland | 198 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#7 | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. | China | 193 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#8 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | China | 178 | Clinical Chemistry Test System Therapeutic Anesthesia Equipment Diagnostic Radiology Equipment |
#9 | DIRUI INDUSTRIAL CO., LTD. | China | 171 | Clinical Chemistry Test System Hematological Reagents Reagents and Specimen Providers |
#10 | COVIDIEN | United States | 167 | Surgical Equipment Therapeutic Anesthesia Equipment Diagnostic Gastroenterology-Urology Equipment |
#11 | SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE) | United States | 166 | Clinical Chemistry Test System Immunological Test System Hematological Reagents |
#12 | AS MEDIZINTECHNIK GMBH | Germany | 150 | Surgical Equipment Surgical Obstetric and Gynaecological Equipment Gastroenterology-Surgical Urology Equipment |
#13 | BOSTON SCIENTIFIC CORPORATION | Costa Rica | 146 | Diagnostic Cardiology Equipment Therapeutic Gastroenterology-Urology Equipment Diagnostic Gastroenterology-Urology Equipment |
#14 | ACRO BIOTECH, INC. | United States | 143 | Clinical Toxicology Test System Serological Reagents Clinical Chemistry Test System |
#15 | DIALAB GMBH. | Austria | 143 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#16 | PATWAL SURGICAL CO. | Pakistan | 141 | Surgical Equipment Surgical Dental Equipment Surgical Obstetric and Gynaecological Equipment |
#17 | ABBOTT IRELAND DIAGNOSTICS DIVISION | Ireland | 135 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#18 | AS MEDIZINTECHNIK GMBH. | Germany | 134 | Surgical Equipment Surgical Orthopaedic Equipment Surgical Obstetric and Gynaecological Equipment |
#19 | HUMAN GESELLSCHAFT FรR BIOCHEMICA UND DIAGNOSTICA MBH | Germany | 134 | Clinical Chemistry Test System Serological Reagents Immunological Test System |
#20 | ORTHO-CLINICAL DIAGNOSTICS | United Kingdom | 132 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#21 | URIT MEDICAL ELECTRONIC CO., LTD | China | 127 | Clinical Chemistry Test System Hematological Reagents Clinical Laboratory Equipment |
#22 | ROCHE DIAGNOSTICS GMBH | Germany | 117 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#23 | BODITECH WITH INC. | South Korea | 116 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#24 | HANGZHOU ALLTEST BIOTECH CO., LTD. | China | 115 | Clinical Chemistry Test System Serological Reagents Clinical Toxicology Test System |
#25 | CELL MARQUE CORPORATION | United States | 114 | Biological Dyes Reagents and Specimen Providers |
#26 | TOSOH AIA INC. | Japan | 109 | Clinical Chemistry Test System Immunological Test System Hematological Reagents |
#27 | SIEMENS HEALTHCARE DIAGNOSTICS INC. | United States | 108 | Clinical Chemistry Test System Immunological Test System Hematological Reagents |
#28 | ZHONGSHAN CAMRY ELECTRONIC CO., LTD. | China | 108 | General and Individual Hospital Equipment Monitoring Monitoring Cardiology Equipment Diagnostic Orthopedic Equipment |
#29 | VARITEKS ORTHOPEDICS INDUSTRY INC. | Turkey | 104 | Prosthetic Physical Health Equipment Therapeutic General and Individual Hospital Equipment Therapeutic Gastroenterology-Urology Equipment |
#30 | ZHEJIANG ORIENT GENE BIOTECH CO., LTD. | China | 104 | Clinical Toxicology Test System Serological Reagents Clinical Chemistry Test System |
#31 | GANSU CONSTAR TECHNOLOGY GROUP CO., LTD. | China | 103 | Therapeutic Eye Equipment |
#32 | SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD | China | 101 | Monitoring Cardiology Equipment Therapeutic General and Individual Hospital Equipment Diagnostic Gastroenterology-Urology Equipment |
#33 | FRIMED MEDIZINTECHNIK GMBH. | Germany | 98 | Surgical Equipment Surgical Obstetric and Gynaecological Equipment Ear, Nose and Throat Surgical Equipment |
#34 | ERBA LACHEMA S.R.O. | Czech Republic | 93 | Clinical Chemistry Test System Hematological Reagents Automatic and Semi-Automatic Hematology Equipment |
#35 | OZON INSTRUMENTS | Pakistan | 92 | Surgical Equipment Surgical Dental Equipment Surgical Obstetric and Gynaecological Equipment |
#36 | GUANGZHOU WONDFO BIOTECH CO., LTD. | China | 91 | Clinical Chemistry Test System Clinical Toxicology Test System Immunological Test System |
#37 | NOPA INSTRUMENTS MEDIZINTECHNIK GMBH | Germany | 88 | Ear, Nose and Throat Surgical Equipment Surgical Equipment Surgical Obstetric and Gynaecological Equipment |
#38 | MICROBIOLOGICS, INC. | United States | 87 | Microbiology Equipment |
#39 | KARL STORZ SE & CO., KG. | Germany | 85 | Diagnostic Gastroenterology-Urology Equipment Gastroenterology-Surgical Urology Equipment Surgical Equipment |
#40 | AMNOTEC INTERNATIONAL MEDICAL GMBH | Germany | 83 | Surgical Equipment Diagnostic Gastroenterology-Urology Equipment Gastroenterology-Surgical Urology Equipment |
#41 | JIANGSU YUYUE MEDICAL EQUIPMENT&SUPPLY CO., LTD | China | 83 | Therapeutic Anesthesia Equipment Diagnostic Cardiology Equipment General and Individual Hospital Equipment Monitoring |
#42 | I-MING SANITARY MATERIALS CO., LTD. | Taiwan | 81 | Prosthetic Physical Health Equipment Therapeutic General and Individual Hospital Equipment General Hospital Equipment and Other Individuals |
#43 | SHENZHEN YHLO BIOTECH CO., LTD | China | 80 | Immunological Test System Clinical Chemistry Test System Serological Reagents |
#44 | ACKERMANN INSTRUMENTE GMBH. | Germany | 79 | Surgical Equipment Diagnostic Gastroenterology-Urology Equipment Surgical Obstetric and Gynaecological Equipment |
#45 | RANDOX LABORATORIES LTD. | United Kingdom | 79 | Clinical Chemistry Test System Immunological Test System Serological Reagents |
#46 | ZYBIO INC. | China | 79 | Clinical Chemistry Test System Hematological Reagents Immunological Test System |
#47 | MERIL DIAGNOSTICS PVT., LTD. | India | 76 | Clinical Chemistry Test System Serological Reagents Immunological Test System |
#48 | THERMO FISHER SCIENTIFIC OY. | Finland | 76 | Clinical Chemistry Test System Immunological Test System Clinical Laboratory Equipment |
#49 | VENTANA MEDICAL SYSTEMS, INC. | United States | 75 | Biological Dyes Pathology Equipment and Accessories Reagents and Specimen Providers |
#50 | ZHANG PU ORTHOLIFE REHABILITATION CO., LTD. | China | 74 | Prosthetic Physical Health Equipment Therapeutic Physical Health Equipment General Hospital Equipment and Other Individuals |
Top 50 Authorized Representatives in Indonesia
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.
