There are 16 categories of medical devices and in vitro diagnostic medical devices that are limited based on their function and application in the health sector. In accordance with the Regulation of the Minister of Health Number 62 of 2017 concerning Distribution Permits for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies, here is a list of these categories:
No | Category | Subcategories |
1 | Clinical Chemistry and Clinical Toxicology Equipment | Clinical Chemistry Test Systems Clinical Laboratory Equipment Clinical Toxicology Test Systems |
2 | Hematology and Pathology Equipment | Biological Stains Cell and Tissue Culture Products Pathology Equipment and Accessories Specimen Preparation Reagents Automatic and Semi-Automatic Hematology Equipment Manual Hematology Equipment Hematology Packages and Kits Hematology Reagents Products Used in the Preparation of Blood and Blood-Derived Preparations |
3 | Immunology and Microbiology Equipment | Diagnostic Equipment Microbiology Equipment Serology Reagents Immunology Laboratory Equipment and Reagents Immunological Test Systems Tumor Antigen Immunological Test Systems |
4 | Anesthesia Equipment | Diagnostic Anesthesia Equipment Monitoring Anesthesia Equipment Therapeutic Anesthesia Equipment Other Anesthesia Equipment |
5 | Cardiology Equipment | Diagnostic Cardiology Equipment Monitoring Cardiology Equipment Prosthetic Cardiology Equipment Surgical Cardiology Equipment Therapeutic Cardiology Equipment |
6 | Dental Equipment | Diagnostic Dental Equipment Prosthetic Dental Equipment Surgical Dental Equipment Therapeutic Dental Equipment Other Dental Equipment |
7 | Ear, Nose, and Throat (ENT) Equipment | Diagnostic ENT Equipment Prosthetic ENT Equipment Surgical ENT Equipment Therapeutic ENT Equipment |
8 | Gastroenterology-Urology (GU) Equipment | Diagnostic GU Equipment Monitoring GU Equipment Prosthetic GU Equipment Surgical GU Equipment Therapeutic GU Equipment |
9 | General Hospital and Personal Equipment (GH & P) | Monitoring GH & P Equipment Therapeutic GH & P Equipment Other GH & P Equipment |
10 | Neurology Equipment | Diagnostic Neurology Equipment Surgical Neurology Equipment Therapeutic Neurology Equipment |
11 | Obstetrics and Gynecology (OG) Equipment | Diagnostic OG Equipment Monitoring OG Equipment Prosthetic OG Equipment Surgical OG Equipment Therapeutic OG Equipment Reproductive Assistance Equipment |
12 | Eye Equipment | Diagnostic Eye Equipment Prosthetic Eye Equipment Surgical Eye Equipment Therapeutic Eye Equipment |
13 | Orthopedic Equipment | Diagnostic Orthopedic Equipment Prosthetic Orthopedic Equipment Surgical Orthopedic Equipment |
14 | Physical Health Equipment | Diagnostic Physical Health Equipment Prosthetic Physical Health Equipment Therapeutic Physical Health Equipment |
15 | Radiology Equipment | Diagnostic Radiology Equipment Therapeutic Radiology Equipment Other Radiology Equipment |
16 | General Surgery and Plastic Surgery Equipment | Diagnostic Surgery Equipment Prosthetic Surgery Equipment Surgery Equipment Therapeutic Surgery Equipment |
Reference:
Permenkes No.62 Tahun 2017
https://peraturan.bpk.go.id/Details/112243/permenkes-no-62-tahun-2017