.png)
The Indonesian Ministry of Health has announced crucial updates regarding the registration of medical devices in the Kamus Farmasi dan Alat Kesehatan (KFA) system. This initiative aligns with the broader national healthcare digital transformation strategy, emphasizing technology, digitalization, and biotechnology integration through the Satu Sehat platform.
Implementation of Electronic Catalogue Version 6
The e-Katalog Version 6 was implemented on 1 January 2025. All businesses are required to include the KFA product code to display their products in the new catalogue, and all medical device license holders must input their products into the KFA system. Healthcare institutions purchasing medical devices through E-Katalog version 6 must ensure that selected products have a valid registration number and KFA code.
Email Synchronization Between KFA and Regalkes
To streamline administration and ensure data synchronization, medical device license holders must update their email addresses in the KFA system to match those in the Regalkes system. This step is critical for smooth transactions and compliance with the new e-Purchasing system starting 1 January 2025.
Important reminder:
Ensure the email used in the Regalkes system matches the email registered in the Online Single Submission (OSS) system
Use a company email that actively receives notifications from Regalkes
Review the list of blocked accounts due to non-compliance with email requirements
Businesses can confirm and activate KFA accounts via the following link: KFA Account Activation
Acceleration Strategy for KFA Code Registration
Medical device license holders are urged to complete their KFA code entries promptly to expedite product registration in the KFA system and ensure compliance with E-Katalog version 6.
The implementation of E-Katalog version 6 marks a significant step in Indonesia’s healthcare digitalization. Medical device license holders must take immediate action to update their records, synchronize email addresses, and ensure compliance with the latest regulatory requirements. Staying ahead in this transition will facilitate smoother operations and uninterrupted market access.
For any inquiries, please send your email to us at info@arqon.com
Source: Kementerian Kesehatan (Kemenkes)
Comments