Regulatory Affairs Update Indonesia

Indonesia: Announcement of the Listing Product Schedule Update in e-Catalogue Ministry of Health

As of December 2023, the Policy Institute for Procurement Goods/Services (Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah (LKPP)) under Ministry of Health (MOH) Indonesia has announced the schedule of Product Listing in e-Catalogue system for Health Facility in Indonesia is open until 31 March 2024 or until further notice.

For stakeholders who plan to list their product in the e-Catalogue this will only allowed before the aforementioned deadline.

The main requirement of listing products in the e-Catalogue is that the product is licensed or approved in Indonesia. Additionally, the distributor must upload technical information of the products, brochure, price structure, and for certain products, must also upload guarantee, and spare part commitment availability letters. Price and other costs must be reasonable and correspond to the implemented regulation.

In regards to Freeze and Unfreeze that regulated by Ministry of Health Decree No. HK.01.07/MENKES/1314/2023 concerning Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Health Medical Devices, the process is still carried out by the Goods and Services Procurement Work Unit (Unit Kerja Pengadaan Barang dan Jasa (UKPBJ) under MOH. Importing medical devices which are similar in specification with domestic medical devices will be permanently frozen if local production of the domestic medical devices can meet Indonesian demands.

For further information on this regulation, please refer to this link.

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