Bryan Gilburg - China

“Manufacturers should prepare the necessary documentation to list their medical devices on the e-catalogue during the upcoming enrollment period.”

Ilham Hidayattulah, Asia Actual Indonesia

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

Sources and Links

Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories

Published on: December 10, 2020

Notice: due to technical issues with the online application system, the LKPP has extended the submission period from January 8th to March 1st 2021.

The Indonesia Ministry of Health recently announced that they will be opening the e-catalogue enrollment period and will soon begin accepting applications for 1,480 product categories. Manufacturers who have not done so already, should expedite the preparation of their applications to ensure their products are listed, as this step is critical to sales success in the market. Manufacturers will need to work with their license holders to complete these applications and ensure that there is a sound pricing strategy across all distribution channels.

Due to the ongoing pandemic, the e-catalogue enrollment will be processed through the upgraded online portal for the first time, while pricing negotiations will still be done face to face.

e-Catalogue Enrollment Application Documents

Manufacturers will need to submit the following documents as part of the application process:

  • Distributor Agreement signed between the foreign manufacturer and the Indonesian Import License holder (original with copy translated into Bahasa Indonesia by a local certified translator);
  • Statement Letter issued by the Indonesia Embassy in the country of origin;
  • Product brochures;
  • Product Import Licenses (AKL);
  • Letter of Authorization from foreign manufacturer to Indonesian Import License Holder;
  • Commercial Invoice – Used to show the landed cost of the product and to be used during negotiation discussions with needed.

Note: Manufacturers wishing to include their distributors in the process will need to make sure their distributors have an LPSE account verified by the government rather than a copy of the distribution agreement like before.

To learn more about the e-Catalogue process, please click here.

Come Grow with Us

Contact Asia Actual if you would like to learn more about the e-catalogue and how it can help boost your sales options in Indonesia.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

Blog Posts

Vietnam to Require Annual Inspection of Certain Medical Equipment

On December 31st, 2020, the Ministry of Health (MoH) issued Circular No. 30/2020 providing a list of medical equipment subject to annual safety inspections and technical capability assessments, along with the timelines for implementation.

India’s CDSCO Extends List of Notified Devices

On December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.

Philippines FDA Announces New Requirement for All Medical Devices

On January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.