KFA Codes and e-Katalog Listing Requirements for Medical Devices in Indonesia

1. Key takeaways

KFA (Kamus Farmasi dan Alat Kesehatan, the dictionary of pharmaceuticals and medical devices) is the national unified product reference database built by Ditjen Farmalkes together with the Digital Transformation Office (DTO). It assigns a unique identification code to every product and carries key fields such as dosage form, packaging, specifications and manufacturer, and it is the connective tissue between hospital information systems (SIMRS), pharmacies and distributors, the government procurement platform (E-Katalog) and the national health data system (SATUSEHAT). Because the same code travels across clinical, distribution and procurement systems, its accuracy determines whether a product can move smoothly through the entire public ecosystem. For government procurement channels, KFA is mandatory: registration alone no longer opens the public market.

• Because the same code travels across clinical, distribution and procurement systems, its accuracy determines whether a product can move smoothly through the entire public ecosystem.
• From 2025, all marketing authorisation holders must obtain a KFA code before their products can be listed on the national E-Katalog or participate in government procurement.
• The requirement rests on the Ministry of Health circular FR.01.01/E/147/2025 issued in 2025.
• KFA first appeared at Technofarmalkes 2022, was established as the national health product reference data standard in 2023, and circular FR.03.01/E.V/1179/2024 of May 2024 promoted early adoption.
• E-Katalog V6 has been implemented since 1 January 2025 and requires every listed product to carry a KFA code matching the Ministry of Health and OSS data.
• Typical listing prerequisites: a valid marketing authorisation (NIE), the IDAK licence, CDAKB certification and the KFA code.
• Email consistency across KFA, Regalkes and OSS is an enforced operational requirement, with account lockups officially named for non-compliant cases.

2. Legal basis

The mandate for KFA codes in procurement derives from the Ministry of Health circular FR.01.01/E/147/2025 (2025), which makes the KFA code a mandatory requirement for E-Katalog listing. An earlier circular, FR.03.01/E.V/1179/2024 of May 2024, had promoted early adoption following the establishment of KFA as the national health product reference data standard in 2023 and its debut at Technofarmalkes 2022. The E-Katalog platform itself is the centralised procurement channel for public health facilities and government agencies, and its management was transferred from LKPP to the Ministry of Health in February 2022. Since 1 January 2025, version V6 of the platform requires that all listed products carry a KFA code that matches the data of the Ministry of Health and the OSS system, and healthcare facilities procuring through V6 must ensure that the products they select hold a valid registration number and a KFA code. The combination of these instruments means that the KFA code now functions as a procurement gate in its own right: it sits alongside, but is distinct from, the marketing authorisation, and it must be obtained through its own process with its own data quality requirements.

3. Expert insights

The operational detail that most often blocks progress is email inconsistency. Kemenkes has explicitly required marketing authorisation holders to update the email recorded in the KFA system so that it matches Regalkes, and to keep it consistent with the OSS registration email, using a company email address capable of receiving notifications normally. Account lockups caused by non-compliant email configurations have been officially named, which means the failure mode is not theoretical: teams discover that their listing work stalls because the three systems disagree about who the licence holder is. The remedy is unglamorous but effective: audit the three systems once, record the canonical company mailbox, and re-check after any corporate change such as a domain migration, since the lockup typically surfaces only when a notification fails to reach the responsible person.

The strategic reading is that KFA and e-Katalog constitute a second workstream, independent of registration. Obtaining the certificate is not the finish line; a product that is registered but not listed effectively forfeits the Indonesian public channel, and the public channel accounts for an extremely high share of the Indonesian device market. Treating listing as an afterthought delays revenue while adding no regulatory benefit, so the KFA application should be sequenced immediately after the marketing authorisation is granted. In practice, the listing workstream also surfaces data quality issues early: mismatches between the registration record and the KFA fields must be corrected before listing succeeds, and finding them during listing is far cheaper than discovering them during a procurement cycle when a tender window is already open.

4. Practical recommendations

• Start the KFA workstream as soon as the marketing authorisation is issued, treating KFA code plus e-Katalog listing as a project with its own owner and timeline.
• Align the email addresses in KFA, Regalkes and OSS before submitting anything, and use a monitored company mailbox that can receive official notifications.
• Verify that the KFA product data, including packaging, specifications and manufacturer fields, matches the registration data, since V6 requires consistency with Ministry of Health and OSS records.
• Confirm the four listing prerequisites in order: valid NIE, IDAK licence, CDAKB certification and KFA code.
• Plan for the V6 procurement checks from the buyer side as well: public facilities must confirm a valid registration number and KFA code, so a product missing either will fail at selection even if the paperwork exists elsewhere.
• Monitor the circulars FR.01.01/E/147/2025 and FR.03.01/E.V/1179/2024 for any updates to the listing requirements, pending verification against current versions.
• For multi-product portfolios, batch the KFA applications by product family so that field data, packaging and specifications are entered consistently across items.

5. Verification checklist

• □ Confirm the circular FR.01.01/E/147/2025 making the KFA code a mandatory requirement for E-Katalog listing.
• □ Confirm the circular FR.03.01/E.V/1179/2024 of May 2024 on early adoption.
• □ Confirm the E-Katalog V6 implementation date of 1 January 2025 and the KFA code matching requirement.
• □ Confirm the KFA email synchronisation requirement as stated in Kemenkes announcements, pending verification.
• □ Confirm the transfer of e-Katalog management to the Ministry of Health in February 2022.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com