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Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices
Published on: July 7th, 2021
New Initiative is Meant to Promote the Purchase of Locally Produced Products
Per Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring medical devices with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products. The change went into effect on June 18th following a a conference between the Ministry for Maritime and Investment Affairs, the MOH, the Ministry of Industry, and the LKPP. The initiative is already in effect on the LKPP’s e-catalogue website as manufacturers and government hospitals have found that medical devices not meeting these requirements are still listed but cannot be purchased.
At this time, it is not clear how long the freeze will last. Affected imported medical devices include autoclaves, hospital beds, surgical gloves and protective gear, cardiac monitors, general surgical and OBGYN instruments, and ECG units. A complete list of the categories can be found below and a Detik Finance article here that also provides a list and additional information. While there is no formal written instructions declaring that imported medical devices cannot be purchased by government hospitals, it does state that the following qualities will be prioritized:
- Locally made products
- Small business entities
- Products with a SNI (Indonesia Standard Industry)
- Environmentally Friendly
Exceptions for Some Imported Medical Devices
Lastly, per Clause 66 point 5, government hospitals are able to purchase imported medical devices if the products can’t be produced domestically or can’t meet the volume needed. However, at this time, it is not completely clear what the process is for processing an exemption to the domestic product requirement given the inability to purchase through the e-catalogue.
These moves are being met with opposition from many Indonesian distributors as well as multinational manufacturers. It will be important to stay alert for changes as the situation evolves.
Products Unfrozen Due to COVID Needs
- HFNC (High Flow Nasal Cannulas)
- CPAPs
- Emergency Ventilators
- Continuous Ventilators (Non Invasive)
- Ventilator for ICUs (Invasive)
- Oxygen Generators
- Oxygen Generator Systems
- Portable Oxygen Generators
- Oximeters
- Patient Monitors
- Infusion Pumps
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Asia Actual has offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia including Jakarta. Contact Asia Actual to see how these changes may impact your business in Indonesia and to stay abreast of this dynamic situation.
Products Currently Affected by e-Catalogue Freeze
Medical ultraviolet air purifier |
Mechanical walker |
Hyperbaric chamber |
Hypodermic single lumen needle |
Piston syringe |
Dye and chemical solution stains |
Alcohol Swab |
Surgical apparel |
Personnel protective shield |
Arm sling |
Steam sterilizer |
Neonatal incubator |
Neonatal transport incubator |
Neonatal phototherapy unit |
Blood specimen collection device |
Blood storage refrigerator and blood storage freezer |
Absorbent tipped applicator |
Crutch |
Dental chair and accessories |
Dental operative unit and accessories |
Liquid chemical sterilants/high level disinfectants |
General purpose disinfectants |
Surgical drape and drape accessories |
Electrocardiograph |
Radiographic film illuminator |
Medical ultraviolet water purifier |
Tuning fork |
High flow humidified oxygen delivery device (Unfrozen on July 7, 2021 due to COVID needs) |
Single/multiple component metallic bone fixation appliances and accessories |
Smooth or threaded metallic bone fixation fastener |
Infusion pump (Unfrozen on July 7, 2021 due to COVID needs) |
Intravascular administration set |
Manual surgical instrument for general use |
Obstetric-gynecologic general manual instrument |
Medical absorbent fiber |
Nonresorbable gauze/sponge for external use |
Hydrophilic wound dressing |
Nonabsorbable gauze for internal use |
Mechanical wheelchair |
Infrared lamp |
Surgical lamp |
AC-powered medical examination light |
Blood pressure cuff |
Medical disposable bedding |
Medical chair and table |
Obstetric table and accessories |
Manual operating table and accessories and manual operating chair and accessories |
Operating tables and accessories and operating chairs and accessories |
Operating tables and accessories with modification |
Radiologic table |
Nasal oxygen cannula (High Flow Nasal Cannula (HFNC) unfrozen on July 7, 2021 due to COVID needs) |
Nebulizer |
Portable oxygen generator (Unfrozen on July 7, 2021 due to COVID needs) |
Oxygen mask |
Cardiac monitor (including cardiotachometer and rate alarm) |
Patient care reverse isolation chamber |
Ophthalmic eye shield |
Mattress cover for medical purposes |
Infant radiant warmer |
Medical recirculating air cleaner |
Sterilization wrap |
Tongue depressor |
Body waste receptacle |
Skin marker |
Needle destruction device |
Elastic bandage |
Medical adhesive tape and adhesive bandage |
Fetal ultrasonic monitor and accessories |
Specimen transport and storage container |
Oximeter (Unfrozen on July 7, 2021 due to COVID needs) |
Sharp container |
Patient examination glove |
Stethoscope |
Hand-carried stretcher |
Wheeled stretcher |
Powered patient transfer device |
Manual patient transfer device |
Powered suction pump |
Vacuum-powered body fluid suction apparatus |
Pediatric hospital bed |
AC-powered adjustable hospital bed |
Hydraulic adjustable hospital bed |
Manual adjustable hospital bed |
Noninvasive blood pressure measurement system |
Human chorionic gonadotropin (HCG) test system |
Human chorionic gonadotropin (HCG) test system (strip & midstream) |
Clinical electronic thermometer |
Infusion stand |
Patient scale |
Stand-on patient scale |
Cane |
Cane, crutch, and walker tips and pads |
Anesthetic cabinet, table, or tray |
Urine collector and accessories |
Patient lubricant |
Visual acuity chart |