Indonesia Removes IDAK Renewals Under New Licensing Framework

On April 1, 2026, Indonesia’s Ministry of Health (MoH) implemented Announcement No. FR.03.06/E.V/0374/2026 on Risk-Based Business Licensing (PBBR) for Medical Device Distributor Licenses (IDAK).

The update introduces several important changes for medical device distributors, including the removal of routine IDAK renewals, mandatory migration from legacy licenses, shorter document correction

IDAK Remains Valid as Long as the Business Operates

Under the new framework, IDAK no longer carries a fixed expiry date. The license remains valid provided the company continues operating and complies with applicable regulatory requirements.

Companies holding active IDAKs with a stated validity period must complete a data update (pemutakhiran) through OSS. The updated validity document issued via OSS becomes an integral part of the existing IDAK.

As a result, companies:

No longer need to renew IDAK periodically
Do not need to separately update technical data in the Regalkes system

This change reduces administrative burden while aligning distributor licensing with Indonesia’s broader risk-based business licensing approach.

Legacy SDAK and IPAK Licenses Must Transition to IDAK

Companies that still hold legacy licenses must convert them to IDAK, including:

SDAK (Sertifikat Distribusi Alat Kesehatan)
IPAK (Izin Penyalur Alat Kesehatan)

To complete the transition, companies must:

Submit a renewal application through OSS
Complete integration with the Regalkes system
Fulfill the applicable requirements under the renewal menu

Distributors that have not yet migrated should assess their licensing status and begin preparations to avoid future regulatory complications.

Shorter Correction Timelines Increase Compliance Pressure

The announcement significantly reduces the time available to correct deficiencies during the application review process.

Previously, applicants received two correction opportunities of 20 working days each. Under the revised framework, applicants receive two correction opportunities of only 10 working days each.

If documents remain non-compliant after the second correction:

The application will be rejected
A new application must be submitted through OSS

While the change may improve regulatory efficiency, it also increases the importance of submitting complete and accurate documentation from the outset. Companies with limited local regulatory resources may face greater challenges meeting the compressed timelines.

Separate IDAK Licenses Required for Multiple Locations

The announcement also clarifies licensing requirements for distributors operating multiple sites.

While an IDAK may reference one or more business locations, companies must ensure each location independently satisfies applicable regulatory requirements. The MoH further states that where multiple locations are involved, separate IDAK applications must be submitted for each location. In practice, this establishes a one-location, one-IDAK approach moving forward.

Companies with expanding distribution networks should review their licensing structures to ensure each operational site is appropriately covered.

Implications for Medical Device Distributors

The revised framework combines regulatory simplification with stricter operational expectations.

Medical device distributors should prioritize:

Updating existing IDAK records through OSS where required
Transitioning SDAK and IPAK licenses to IDAK
Strengthening document preparation processes to meet shorter correction deadlines
Reviewing licensing coverage for each business location
Confirming compliance with OSS and Regalkes integration requirements

For companies involved in the distribution of medical devices in Indonesia, proactive planning will be essential to avoid disruptions and maintain regulatory compliance.

Final Thoughts

Indonesia’s latest IDAK reforms reflect a broader regulatory shift toward continuous compliance rather than periodic licensing renewals. While the new framework reduces administrative burden by eliminating routine renewals, it also places greater responsibility on distributors to maintain accurate licensing records, manage transitions from legacy licenses, and respond quickly to regulatory requests.

For overseas manufacturers, authorized representatives, and distributors, compliance will increasingly depend on the quality of internal regulatory processes rather than renewal cycles alone. Companies that proactively review their licensing structures, documentation practices, and multi-site operations will be better positioned to avoid delays, application rejections, and potential disruptions to market access in Indonesia.

Cisema supports companies through every stage of the process, from IDAK applications and legacy license conversions to broader regulatory affairs and market-entry support in Indonesia. For assistance with navigating these evolving requirements, contact Cisema today.