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INDONESIA ENFORCES MEDICAL DEVICE LABELING REQUIREMENTS

The new medical device regulations (Permenkes No. 62, 2017, Marketing Authorization of Medical Devices, IVD Devices and Household Goods.) that went into effect on January 12, 2018 include the requirement that the Instruction for Use (IFU) including intended use, contraindications, attentions, and warnings be translated into the local language (Bahasa Indonesia) (ref. Paragraph 41, Clause 6). Implementation of this requirement was to be given a two year grace period (e.g., through January 12, 2020).

However, the Ministry of Health has been requesting the IFU in Bahasa Indonesia starting in March of this year as a supplemental document request for registration applications.  As such, it is recommended that all new device registration applications include the IFU in local language.

At this point, devices with valid registration certificates (AKL) previously issued without IFU in local language, may continue to be imported and sold into the Indonesian market.  Any future amendment to the AKL should include addition of the IFU in Indonesian language. Device manufacturers should still check with their Indonesia license holder for any active AKL certificates to confirm the IFU requirements individually.

Classification of Medical Device

International ClassificationExamplesRisk Level
ACholesterol, uric acid test system
Surgical Instrument; Bandage
Surgical camera; Electric operating table
Patient scale
Low
BPregnancy self testing
Electric Hospital Bed
Surgical Lamp, Surgical Mask
Low – Moderate
CBlood glucose self testing
ECG, X-ray Unit, Syringe
Condom, Contact lens
High – Moderate
DHIV Blood donor screening, Stent
Intraocular lens (IOL), Defibrillator, Pacemaker
High

Asia Actual has a local, licensed office in Jakarta to provide medical device registration, license holding, importing and commercial support services in Indonesia. Please contact us with any questions or support requests.

INDONESIA CALLS FOR NEW ROUND OF E-CATALOGUE APPLICANTS

In response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline. (formal announcement letter here)

Interested Import License (AKL) holders of a registered medical device/s have until 14:30 on Thursday, July 26th to prepare and submit an application at the MOH office at Meeting Room ULPYankes 4 floor, Adiyatma Building. Jl. H.R Rasuna Said Blok X5 Kan. 4-9, Jakarta 12950.

The MOH will process the applications and forward a list of suggested device categories to the Indonesian government procurement agency, LKPP, for eligibility for e-Catalgoue enrollment this year.

Required elements of this application include:
  1. Application letter
  2. List of products (template provided by the MoH)
  3. Original Scan of IPAK
  4. Original Scan of AKL
  5. Brochure, leaflet, and product information
  6. Documents submitted must be soft-copy on a USB stick

The LKPP’s planned acceptance of e-Catalogue listing renewal applications is on schedule.  However, the planned call for new enrollment applications has been postponed, but expected at any time.

Contact us:

Asia Actual’s office in Jakarta is monitoring the situation closely.  Please contact us for the latest updates.

INDONESIA E-CATALOGUE ENROLLMENT DEADLINE JUNE/JULY 2019

The Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019.  (reference LKPP No. 5265/D.2.2/05/2019)

Initial guidance from LKPP was that no new e-Catalogue applications would be accepted this year. However, in response to industry feedback, new e-Catalogue listing applications may be accepted on a limited basis under the following conditions:

  • Companies with interest in making application for a new e-Catalogue listing, must submit an application to the Ministry of Health (MoH) by this Friday, June 21. The MoH will then select among applicants and submit a list of device categories for new registrations to the LKPP this year. 
  • Medical device manufacturers with interest in new e-Catalogue listings should coordinate quickly with the holder of their Import Licenses (AKL) to make application this week to the MoH.  It is also advisable to begin assembly of the full LKPP e-Catalogue enrollment application as certain documents require Authentication from the Indonesian Embassy in the country of origin, which can take several weeks. 

The Ministry of Health applications requires the following documents (submitted in soft-copy on USB stick):

  1. Application letter with a list of products of interest (templates provided by MoH) (reference MOH No. KN.01.01/I.4/5945/2019)
  2. Original scan of importers Distribution License (IPAK)
  3. Original scan of product Import License (AKL)
  4. Product brochure, leaflet, and information 

The LKPP application intake will commence in July, followed shortly by price negotiation meetings with new e-Catalogue listings targeted for October.

Asia Actual is available to answer questions. Contact us to arrange an initial conversation.