ILHAM HIDAYATTULAH

“The initiative is already in effect on the LKPP’s e-catalogue website.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

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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:

  1. Locally made products
  2. Small business entities
  3. Products with a SNI (Indonesia Standard Industry)
  4. 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

Due to the increasing number of COVID-19 cases in Indonesia, the MOH decided to unfreeze the following items on July 7, 2021 which had been frozen since June 18, 2021:
  1. HFNC (High Flow Nasal Cannulas)
  2. CPAPs
  3. Emergency Ventilators
  4. Continuous Ventilators (Non Invasive)
  5. Ventilator for ICUs (Invasive)
  6. Oxygen Generators
  7. Oxygen Generator Systems
  8. Portable Oxygen Generators
  9. Oximeters
  10. Patient Monitors
  11. Infusion Pumps

Come Grow With Us

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

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