Indonesia Medical Device Registration Timelines in 2025

1. Overview of the Registration Process

Indonesia’s medical device registration is managed by the Ministry of Health (Kemenkes) through the Directorate General of Pharmaceutical and Medical Devices. All devices require a Distribution Permit (SDAK or Izin Edar Alat Kesehatan) before market entry. Timelines depend on risk classification (A–D per ASEAN MDD), dossier completeness, and authority workload. https://cisema.com/en/indonesia-device-timelines-2025/

2. Risk Classification and Typical Timelines (2025 Estimates)

• Class A (low risk): 3–6 months
  Simple devices with minimal documentation; often administrative review only. https://cisema.com/en/indonesia-device-timelines-2025/
• Class B (low-moderate risk): 6–12 months
  Moderate documentation; technical review required but usually faster than higher classes. https://cisema.com/en/indonesia-device-timelines-2025/
• Class C (moderate-high risk): 9–18 months
  Detailed technical dossier, including clinical data; extended evaluation periods common. https://cisema.com/en/indonesia-device-timelines-2025/
• Class D (high risk): 18–24+ months
  Comprehensive technical and clinical evaluation; frequent requests for additional information or clarifications. https://cisema.com/en/indonesia-device-timelines-2025/

These are indicative timelines and may be longer due to backlog, incomplete submissions, or complex products.

3. Factors Influencing Timelines

Several elements can extend or shorten the process:

• Dossier quality — Complete, well-organized submissions using ASEAN CSDT format reduce delays.
• Local agent efficiency — Prompt responses to authority queries accelerate progress.
• Product complexity — Implantables, software as medical device (SaMD), or combination products often face longer reviews.
• Regulatory changes — 2025 updates to e-registration systems or post-market requirements may impact processing times.
• Peak periods — Year-end or post-holiday backlogs can add 2–4 months. https://cisema.com/en/indonesia-device-timelines-2025/

4. Expedited Pathways

• ASEAN reliance — Devices with marketing approval in reference ASEAN countries may qualify for faster review via CSDT pathway.
• Priority products — Certain essential or innovative devices (e.g., during public health emergencies) can receive expedited handling.
• Pre-submission consultation — Early dialogue with authorities can help avoid major deficiencies and shorten overall timelines. https://cisema.com/en/indonesia-device-timelines-2025/

5. Post-Registration Considerations

After permit issuance:

• Validity is typically 5 years (renewal required).
• Annual post-market surveillance reporting is mandatory.
• Changes to device or labeling require variation applications, which may take 3–12 months depending on scope. https://cisema.com/en/indonesia-device-timelines-2025/

Accurate planning, strong local support, and high-quality submissions remain key to achieving registration within expected 2025 timelines in Indonesia’s evolving regulatory environment. https://cisema.com/en/indonesia-device-timelines-2025/