ILHAM HIDAYATTULAH

“It is expected that the MOH could update the list of frozen products on a weekly or monthly basis. This being said, there have not been any new frozen categories since the original 79 were announced in June 2021.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

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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

Products Currently Frozen on e-Catalogue

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

Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue

Published on: August 5th, 2022

On July 6, 2022, the Ministry of Health released updated guidance KMK No. HK.01.07/MENKES/1258/2022, found here in Indonesian and English, outlining the process for freezing eCatalogue product categories. This comes a year after the first 79 categories were frozen and provides manufacturers with more information on the decision making process. The eCatalogue, locally referred to as the e-Katalog, can be found here.

The freezing process applies to foreign manufacturers that produce products outside of Indonesia. The intention of this new policy is to encourage the local production of certain types of medical device products and a full list of the 79 categories can be found at the bottom of the article as well as a list of items unfrozen to help fight COVID-19.

Implications of Frozen eCatalogue Product Categories

Manufacturers entering the Indonesian market will want to consider the potential implications of this new process. Specifically, manufacturers of general use or “me too” should keep an eye on the number of domestically produced similar products since their product category will likely be frozen once domestic production can meet the national demands. At this time, there is no established appeal process for manufacturers to utilize should they disagree with the MOH’s freeze status on their product category.

On the other hand, manufacturers of innovative devices or product types not currently being produced in Indonesia should feel safe that their products won’t be frozen given there is very little, to no, domestic competition and won’t be for a while.

Lastly, manufacturers considering registration in Indonesia will want to review the list of frozen product categories in order to avoid obtaining a registration for a product that can’t be sold to a significant portion of the Indonesia hospitals. Per data from the MOH, of the 2,813 hospitals in Indonesia in 2019, 63-64% are run by private organizations.

Mechanisms for Freezing Medical Devices

At this time, there are 79 categories currently frozen, including many low risk, common devices such as blood specimen collection devices, neonatal incubators, disinfectants, electrocardiographs, etc. By freezing these product categories, international manufacturers are barred from listing their products on the eCatalogue which facilitates all government purchases. Therefore, product categories added to the frozen list could significantly affect sales for international manufacturers if they solely rely on public hospital sales in Indonesia.

Once a product category is frozen, the MOH will monitor the domestic supply to ensure production can meet demand. If production is sufficient, the product category will likely remain frozen. However, if hospitals begin having issues sourcing products, the MOH will consider unfreezing product categories to allow for the importation and sale of foreign produced products.

In regards to evaluating new eCatalogue listings, the Indonesian government is currently forming a substitution team to review products submitted to the eCatalogue. The team will then determine whether the product is frozen or un-frozen with a timeline of 7 working days. If the product is included in the freeze criteria, then it won’t be allowed on the eCatalogue and will be permitted the unfrozen category. The MOH has provided the below process overview to help stakeholders better understand the decision-making process.

Implementation Process

With the release of the new guidance, the MOH is quarantining new eCatalogue listings submitted after July 6th to ensure none of the products are found on the frozen list. It’s then expected that the MOH will unfreeze permitted product listings, allowing domestic public healthcare providers to purchase the products. Moving forward, the Import Substitution team will review all new listings within 7 days to ensure frozen products are not being listed and made available for purchase.

Producing Medical Devices in Indonesia

As previously noted, the goal of the new policy is boost domestic production while also encouraging international manufacturers to shift some of their production to Indonesia. When first implemented in 2021, the MOH estimated that the freezing of the initial 79 product categories would benefit the sale of 5,462 licensed medical devices and could be worth an estimated IDR 6.5 trillion (~US$100 million).

Manufacturers that wish to produce products locally and reduce the risk of having their products frozen will need to manufacture locally and obtain an AKD license designating the product as “Domestic” whereas products susceptible to the freeze will have AKL licenses. Manufacturers could also work with local companies to repackage or reassemble their products to meet these requirements.

Enrolling in the eCatalogue and Developing a Strategy

Under the new process, enrolling in the e-Catalogue will be easier than ever for manufacturers. MOH not only removed the price negotiation step but has also extended the enrollment window to almost 9 months. Manufacturers will need to work with their local partner to submit the necessary documents which includes the company deed, the medical devices license (AKL), and more.

It will also be important for manufacturers to develop and implement an e-catalogue pricing strategy. Manufacturers still have a month or two before all products have been moved over to the Sectoral catalogue but once this has been completed,  manufacturers and their partners will be able to update daily if they want. Prices will be non-negotiable and products will be sold at the listed price. This varies from the similar system in Vietnam where prices can be negotiated down from the listed price but since hospitals are required to publish the final price publicly, everyone is still able to see the final price.

To learn more about the Indonesia e-Catalogue system, please see our landing page here.

To learn more about the Vietnamese Medical Device Disclosure Portal please see our blog and landing page here.

Come Grow With Us

Asia Actual works closely with clients to optimize pricing and obtain the fastest eCatalogue listing for your devices. Contact Asia Actual if you have questions regarding this new policy and/or need support with your Indonesia eCatalogue Strategy or Registration. Asia Actual has offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia including Jakarta.

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