ILHAM HIDAYATTULAH

“E-Catalogue enrollment has been as easy as announced in the beginning of the year. The only catch is if your product category is on the quarantine list.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Important Documents and Links Related to the eCatalogue

Sign Up For Our Newsletter to Stay Informed

Sign Up

Indonesia e-Catalogue Implementation Review, December 2022

Published on: December 30th, 2022

Indonesia e-Catalogue Implementation Review, December 2022

Earlier this year the Indonesian government took major steps to make it easier to get products listed in their e-Catalogue, which can be accessed here. On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.

This is a clear improvement from the previous system, where e-Catalogue submissions could only be completed during a specific period once a year. Given the significance of the business implications for this new process, in this article, we hope to provide an assessment of how the implementation is going, as well as focus on the specific updates that the Indonesian MoH have made and how they will affect manufacturers moving forward.

Please contact Asia Actual if you need support listing your products on the Indonesia e-Catalogue or require further information.

Indonesia e-Catalogue (e-Katalog) Features and Overview

Also locally known as the e-Katalog, it is important to note the various features of the system and how it functions.

  • Once listed, public hospitals and other health providers can find and purchase listed products.
  • Private hospitals will also typically purchase from the e-Catalogue but are not required to.
  • Applicants can set their e-Catalogue pricing without negotiating with the MoH/LKPP. Originally the price was expected to be within a 40% mark up of landed costs (as evidenced by PIB/commercial invoice from the actual importation) but at this time there is no formal language stating this requirement under the new guidance.
  • Commercial distributors can be changed or added at any time with a simple on-line administrative form.

Manufacturers, through their license holder, can submit new pricing anytime rather than during a short, designated period like the previous process. Under the old requirements, some manufacturers could receive their license approval in the Fall but not list until the following Summer, causing delays to business development in the country of 276 million people.

These changes will be welcomed by hospitals, healthcare workers, and medical device manufacturers as they speed up the process and permit manufacturers to adjust prices independently. Structurally, medical device listing in e-Catalogue will be moved to a new Healthcare Sector administration which will be processed by the Ministry of Health. Importantly, the requirement for certain documents to be authenticated by the Indonesian Embassy in the country of origin has been eliminated. This will significantly reduce the time for application preparation.

Implementation Assessment of the New e-Catalogue Process

As of the end of 2022, this new eCatalogue process is working well with nearly 10,000 products currently listed. The new system significantly benefits manufacturers as access to the e-Catalogue provides access to the entire public sector.

A major rework of the eCatalogue system was just implemented in February of 2022 (see associated article here and the official announcement here). While the software platform itself seems to sometimes struggle to keep up with increased demand for new listings with occasional “suspension of service” reports, the Ministry of Health has been tweaking the enrollment policies.

Additionally, there is a 7 day review, which is a quarantine process implemented by the MoH in order to create new regulations for Substitution Imported Medical devices with Domestic Medical Device in the Health Sector E-Catalogue. Check this link for further information on the product category freezing process.

Earlier this year the MoH quarantined new eCatalogue listings submitted after July 6th to ensure none of the products were frozen on the site. 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.

Another element to note is that the eCatalogue currently gives preference to local products and manufacturers, supporting domestic products over imported ones. For instance, regulations currently require that manufacturers import a physical product to successfully list their product which can cause issues for software (SaMD) products that can be downloaded from the internet.

Import documentation is required to view the basic price, the other documentation required from the manufacturer being product brochures and technical specifications. At this time, Asia Actual gives the implementation of the new process a B+ as the transition has gone smoothly without any significant delays.

While the total listed products has not yet met the initial goal of 20,000 products, the process is undoubtedly benefiting manufacturers by lowering the barriers to selling their products to Indonesia’s 2,500 hospitals.

COME GROW WITH US

Asia Actual has an office in Indonesia staffed by experienced, bilingual regulatory and commercial professionals who can address any questions or provide support. Please contact us for further information about the Indonesia eCatalogue and the potential to list your device.

Asia Actual is a regulatory consulting company established to help device manufacturers grow sales in challenging Asian markets through independent license holding, direct fulfillment, and a variety of sales channel support services.

Blog Posts

Thai FDA Documentation Exemptions for Concise and Full Regulatory Pathways

Thai FDA Regulatory Documentation Exemptions

March 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Read more
Hong Kong MDD adds Singapore HSA to Reference Country List

Hong Kong MDD Adds Singapore as Reference Country

Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the "Essential Principles of Safety and Performance of Medical Devices" (Technical Reference: TR-004) under MDACS.
Read more
collaborative initiative by Philippine Authorities will have far reaching benefits, not just for foreign and domestic medical device and pharmaceutical manufacturers but for the Filipino economy as well.

Philippines Incentivizing Local Medical Device Manufacturing

On March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.
Read more