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.

Indonesia Medical Device e-Catalogue Enrollment: 2018 Debrief

Access to the public hospital on-line procurement system, e-Catalogue, is an important part of a successful sales strategy in Indonesia for most medical and diagnostic devices. At the same time, navigation of the enrollment process is a challenge for many manufacturers and distributors. To be positioned for successful e-Catalogue listings, it is important to understand the submission process and to anticipate expected changes for 2019.

The e-Catalogue system in Indonesia is managed by the LKPP (The Government Agency for Procurement of Goods & Services).

Application Deadlines

On March 26th the LKPP released the enrollment schedule for 2018 with the deadline for application submission set at April 20th. Applicants had just 20 working days to prepare. Successful applicants were notified on April 30th.  Price negotiation meetings were to be completed by May 4th, but due to high application volumes the deadline has been extended through December 2018. This was a much-accelerated schedule compared to previous years.

Eligible Products List

At the same time three, separate lists were published identifying 613 categories of eligible devices. Enrollment eligibility has varied over the years from first-in-first-out open enrollment from 2014 to 2016; to periodic by-invitation-only from 2016 to 2017; to the current mass enrollment one-time per year established in 2018.

Required Documents

The list of documents required for the e-Catalogue application for medical devices has changed several times making advanced preparation difficult. (The latest version is the LKPP 5th schedule published on June 7, 2018.) Verification of application documentation is very strict, and many applications have been rejected for non-compliance. Particularly challenging is getting authentication of the Distributor Appointment Letter (Surat Tanda Pendaftaran, or STP) by the Ministry of Trade at the Indonesia Consulate in country of origin due to processing time requirements.

Pricing

Price negotiations seem to be restricted to between 20% and 40% of the Landed Cost of a device (inclusive of CIF charges). The range depends on effective justification of the support effort and costs. Sufficient time should be budgeted for e-Catalogue pricing strategy consideration and negotiations preparation.

2019 Enrollment

In 2019 significant changes are expected for e-Catalogue enrollment for medical and diagnostic devices with management being shifted from the LKPP to the Ministry of Health. The next intake is expected in July 2019 with what may be open enrollment for all product categories. Distributor markup is anticipated to be fixed at 1.4 times Landed Cost.

Manufacturers should begin now to register devices of interest for e-Catalogue listing choosing their local Indonesia Agent carefully. It is important to prepare applications early according to current requirements and stay vigilant any additional changes.

Asia Actual‘s experienced staff in Jakarta is available to respond to questions and support requests.

Indonesia Tightens Enforcement of Medical Device Licensing

With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.

Formerly, compliance for imported medical devices was confirmed during the customs clearance process by Customs and Excise Department officials. Now the Ministry of Health is authorized to extend confirmation through inspection at medical device distributors (AKA, Post-Border monitoring).

Any devices without proper licensing may result in re-exportation or destruction at the importers expense. Further, distributors in possession of improperly licensed devices may have their Distribution License suspended.  The move is expected to increase compliance with the medical device registration requirements.

Indonesia the Next to Takes Steps Toward ASEAN MDD Harmonization

On January 13, 2018 the Indonesia Ministry of Health implemented Permenkes No. 62, 2017, Marketing Authorization of Medical Devices, IVD Devices and Household Goods. This is the first major overhaul of medical device regulations in seven year (replacing Permenkes No. 1190, 2010) with the intent to improve efficiency, harmonize with ASEAN MDD standards, and align with updates to Indonesian legal and import regulations.

Important provisions include: 

  1. device definitions harmonized with ASEAN MDD
  2. device classification harmonized with ASEAN MDD
  3. technical data formatting harmonized with ASEAN MDD (CDST)
  4. application review times for medical device registration cut in half (15 days for Class A, 30 days for Class B and C and 45 days for Class D) for import goods
  5. implementation of E-reporting systems for distribution records and complaint handling through E-Watch systems
  6. clear requirements for post market vigilance

Implementation of the new Rules has been rather smooth with new faster review timelines largely being met. Indonesia is the third country to implement the ASEAN MDD standards after Singapore and Malaysia, with the Philippines announcing plans for implementation in early 2019.

Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices

The Ministry of Health has outlined requirements for clinical trials conducted in Indonesia in Regulation No. 63, 2017 published on December 28, 2017.

Included are details on the required elements of a clinical trial application, and description of the application review process conducted by a Ministry of Health appointed Health Research Ethics Committee.  The local clinical trial standards, CUKAKB “Cara Uji Klinis Alat Kesehatan yang Baik”, are based on ISO 14155.

The new Rules are viewed as preparation for increasing the requirement for local clinical trial data for high risk Class C/D and novel medical devices registration applications in Indonesia.

Indonesia Ministry Opened e-Catalogue Registration for Certain Medical Devices

The Ministry of Health recently open e-Catalogue registration to 242 types of devices in 17 categories.  License holders of these devices were given three weeks to submit applications with a July 14th deadline.  A copy of the Ministry announcement (in Bahasa Indonesia) is available on the Indonesia page of the Asia Actual web site.

After slow initial adoption, participation in the e-Catalogue procurement system is now understood to be highly advantageous to public hospitals sales in Indonesia. As a result, enrollment applications have overwhelmed the Ministry of Health’s processing capacity.

Initially, The Ministry of Health processed applications on a first-come-first-served basis.  Wait times under this approach steadily increased from 3 months to 6 months or longer.  Applicants were limited to 10 devices per session.  More recently, the Ministry had stopped accepting enrollment applications for medical devices all together.

This new action signals a change in approach to call for blocks of devices at one time.  There was no limit to the number of device applications submitted per license holder.  It is expected that the Ministry will call for a new block of devices in the coming months.

Medical device manufacturers are advised to work with their Indonesia license holder to prepare enrollment applications in anticipation of their device category being called in the next session.

Indonesia’s e-Catalogue System Overview

An important, new consideration to sales success in Indonesia is the e-Catalogue listing. This on-line procurement system was established to bring transparency and prevent corruption in government purchases, including public hospitals, as administered by the Indonesian Government Goods and Services Procurement Organization (LKPP).

Although initiated in 2013, it took parties some time to understand the implication on sales. At first, companies seemed weary to participate in the voluntary system. Those that did enjoyed strong sales results and so now there is a rush for all to be listed.

​After an Import License for a device is issued, the License Holder can apply to the Ministry of Health for an e-Catalogue listing meeting at which the listing price will be negotiated. A required element for the meeting is a commercial invoice from at least one device shipment to Indonesia. Price negotiations are for a percentage mark-up from the invoiced landed cost typically between 25% to 35%. There is no government application fee for the application process, but the queue can be 6 months or longer for the price negotiation meeting.

Implementing an optimal pricing strategy will be critical to successful public hospital sales. ​The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.

​Asia Actual works closely with clients to optimize pricing and obtain the fastest e-Catalogue listing for your devices.