Regulatory Affairs Update: Indonesia

Indonesia: Appeal for Filling in Medical Device Dictionary Data

On July 16, 2024, the Indonesia Ministry of Health (MoH) issued an announcement letter No. FR.01.01/E.V/1537/2024 regarding the Appeal for Filling in Medical Device Dictionary Data.

The MoH has again requisitioned all companies holding active product licenses for medical devices to fill in the Pharmacy and Medical Devices Dictionary (KFA) to increase health resilience and the growth of the domestic medical devices industry.

The MoH will substitute imported medical devices with domestic medical devices in the health sector electronic catalogue (sectoral e-Catalogue) through a freeze-and-unfreeze mechanism, using data in the KFA to assess the freeze-and-unfreeze process of imported medical devices.

Companies holding distribution permits are advised to fill in variant product data in the KFA through the link shared in the announcement letter.

The announcement letter, as well as the list of medical devices that are already listed in the KFA system, can be accessed here (in Indonesian language).

Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.

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