Indonesia MoH Announces Temporary Closure of Medical Device Regulatory Systems

On November 11, 2025, the Indonesian Ministry of Health (MoH), Directorate of Medical Device Production and Distribution, released an official notification announcing a temporary shutdown of several regulatory platforms in December 2025 and early January 2026.

As the MoH completes system upgrades, implements “Permenkes 11/2025,” and manages year-end PNBP administrative processes, the closures will affect:

• IDAK
• Online Registration for Medical Devices
• Online Certificate Services

These changes have important implications for companies monitoring Indonesia’s medical device regulation and planning submissions across the MoH’s digital portals. For regulatory support during this period, contact Cisema today.

MoH System Closures and Affected Licensing Services

The following sections describe the confirmed disruptions to key MoH licensing and registration platforms and outline the actions applicants should take ahead of the transition period.

IDAK (Medical Device Distributor License)

The IDAK shutdown will limit new submissions and renewals during the closure window. Early preparation will help companies avoid distribution interruptions.

Key points include:

• New, renewal, and variation submissions will be unavailable from December 15, 2025 to January 9, 2026.
• Applications already under evaluation will continue to be reviewed.
• Applications in “Applicant – Additional Data Required” status will remain on hold until the system reopens.
• Billing codes (SPB) already issued must be paid with proof of payment uploaded by December 31, 2025.

Online Registration for Medical Devices (Marketing Authorization)

The temporary suspension will affect all marketing authorization activities. Applicants with upcoming renewals face several time-sensitive requirements.

The MoH emphasized the following:

• New submissions, renewals, and variations will be closed from December 15, 2025 to January 9, 2026.
• Billing codes issued before the closure must be paid with proof of payment uploaded by December 31, 2025.
• Applications already under evaluation will continue to be processed.
• Licenses due to expire during the closure must be renewed by Friday, December 12, 2025. Missing this deadline may result in the temporary loss of market access, as products without valid licenses cannot be distributed.
• If the renewal deadline is missed, applicants must submit a new application once the system reopens.

Online Certificate Services

Online certificate functions will also be paused as part of the year-end transition, requiring applicants to complete outstanding steps before the closure.

The MoH announced that:

• Online certificate applications will be unavailable from December 22, 2025 to January 5, 2026.
• Applications under evaluation will continue to be processed.
• All billing codes must be paid by December 31, 2025.

These measures are intended to ensure system migration, regulatory updates, and administrative alignment related to the year-end PNBP cycle.

Preparing for the MoH Shutdown: Key Actions for Medical Device Stakeholders

With several MoH systems scheduled to close temporarily, organizations should align their regulatory, financial, and operational teams to avoid delays. The steps below outline who should take action and what must be completed before the shutdown.

1. Actions for License Holders Managing Indonesia Medical Device Registrations

Teams responsible for maintaining registrations should confirm which licenses may be affected and ensure timely renewal.

Required actions include:

• Regulatory Affairs teams or staff handling registrations review all licenses expiring between December 15, 2025 and January 9, 2026.
• Those managing submissions file renewals no later than December 12, 2025.
• Team members responsible for dossier updates resolve any “Additional Data Required” items as early as possible.
• Regulatory or commercial planning teams assess whether approvals expected in late 2025 may be impacted.

Organizations facing resource constraints or complex portfolios may consider external support from a regulatory consultancy to ensure deadlines are met.

2. Payment Responsibilities for Applicants Using Indonesia MoH Licensing Systems

Teams involved in MoH payments should ensure billing codes do not lapse during the year-end cut-off.
Key tasks include:

• Finance teams or individuals managing regulatory payments settle all SPB and billing codes by December 31, 2025.
• RA staff or portal users upload proof of payment promptly after payment is made.
• Internal coordinators align payment timelines with MoH deadlines to avoid processing gaps.

3. Regulatory Affairs Priorities Ahead of the Indonesia MoH System Freeze

RA teams should fast-track dossier preparation to ensure everything is ready before systems go offline.
Responsibilities include:

• Dossier preparers or regulatory coordinators finalize submission materials and secure required approvals early.
• Regulatory reviewers or case managers check active submissions for any items needing urgent updates.
• Project leads set internal deadlines and track progress against MoH timelines.

Given the compressed timeline, companies may seek to engage regulatory consultancies like Cisema for hands-on support with dossier compilation, regulatory planning, or communication with Indonesian authorities.

4. Actions for Supporting Functions

Broader internal teams also contribute to keeping submissions on track and preventing compliance gaps, particularly when documentation or operational planning is involved.

Key actions include:

• QA personnel or document owners provide technical documents and required certificates ahead of time.
• Supply chain or operations teams adjust plans if approval delays could affect distribution.
• Finance personnel prioritize regulatory-related payments before year-end.
• Principals or manufacturers deliver supporting documentation or authorizations needed for renewals or variations.

Key Takeaway: Prepare Early to Maintain Indonesia Market Access

Proactive preparation during early December is critical to keeping renewals, payments, and dossier activities on track before the MoH systems go offline. To achieve this, coordinated action across regulatory, operational, and financial teams will help companies maintain market access and avoid delays during the shutdown.

As organizations finalize their year-end compliance actions, many also find that localized expertise can ease the timing pressures introduced by the system closures. For tailored support with Indonesia medical device registration, renewals, or broader regulatory strategy, contact Cisema’s regulatory specialists for guidance.

Further Information

• Explore Cisema’s medical device registration services in Indonesia

References

• Read the original announcement “PENUTUPAN SEMENTARA SISTEM PERIZINAN ALAT KESEHATAN DAN SURAT KETERANGAN ONLINE” (Bahasa Indonesia)
• Read Permenkes 11/2025 “Regulation of the Minister of Health of the Republic of Indonesia Number 11 of 2025 Concerning Business Activity Standards and Product/Service Standards in the Implementation of Risk-Based Business Licensing in the Health Subsector”