Regulatory Affairs Update: Indonesia

Indonesia: Ministry of Health Letter of Filling New System of Pharmacy and Medical Device Dictionary (KFA: Kamus Farmasi dan Alat Kesehatan)

On May 21, 2024, the Indonesian Ministry of Health (MoH) issued a letter numbered FR.03.01/E.V/1179/2024 regarding Filling the New System of Pharmacy and Medical Device Dictionary (KFA), which was signed on 14 May 2024. KFA is a dictionary that contains unique codes for pharmaceutical products and medical devices and can be used and integrated into all systems used by the healthcare industry.

The MoH issued this letter to follow up on the Pilot Project Trial meeting for product template input in the KFA system held on May 7, 2024. Representatives from medical device associations (GAKESLAB and ASPAKI) and 25 medical device companies attended this meeting. Training on inputting product variants and attributes in the KFA system was also conducted.

The MoH stated that the  Directorate of Medical Device Production and Distribution, together with the Digital Transformation Office (DTO), has created Product Templates for 25 types of medical device products with 9610 shells (cangkang) in the KFA system (Medical Devices), which has the web address of The medical device industry will then complete product variants and attributes.

  1. To speed up the process, data input into the KFA Dictionary (Medical Devices) system was targeted until 31 May 2024.  The data inputted will be used for the pilot project on import product substitution following MoH Decree No. 1314 of 2023 on the Substitution of Imported Drugs and Medical Devices with Domestic Drugs and Medical Devices in the Electronic Catalogue of the Health Sectoral.
  2. GAKESLAB and ASPAKI are expected to conduct socialization with their members and medical device providers with regard to the KFA input with template products that are already available. According to the product templates in the KFA system, the MoH expected that the product template filling could be completed by June 30, 2024. The data is used to expand pilot project coverage of import product substitution provisions according to the MoH Decree No. 1314 of 2023.

The MoH shares a link for all information on KFA at and if there are problems in filling out the KFA (Medical Devices), there is an email that can be contacted at The letter numbered FR.03.01/E.V/1179/2024 issued by the MoH can be accessed here (in Bahasa Indonesia).

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