IVD Registration in Indonesia: Classification and TTI Screening Requirements

1. Key takeaways

In vitro diagnostics in Indonesia sit squarely within the medical device regime: the same ministry, the same four risk classes, and the same licence architecture apply. What distinguishes the IVD track is the additional evidence demanded for transfusion-transmitted infection screening reagents at the renewal stage, which is the point where many IVD renewal projects stall.

• IVD products fall within the medical device scope and are regulated by Kemenkes, not by BPOM, and they are classified under the same A/B/C/D four-class risk scheme as other devices.
• The IVD definition covers reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems, used alone or in combination, for in vitro examination of specimens derived from the human body.
• Appendix 3 of Permenkes 11/2025 sets additional requirements at the renewal stage for IVDs used for screening of transfusion-transmitted infections (TTI): documents demonstrating sensitivity and specificity, which must meet the statutory standards for TTI screening; and a verification test report issued by a laboratory or testing institution designated by the Minister.
• Acceptable testing bodies include accredited laboratories in Indonesia, certified testing institutions, or laboratories and testing institutions designated by Kemenkes.
• The practical consequence: TTI reagents, such as reagents for screening of HIV, hepatitis B, hepatitis C and syphilis, cannot be renewed in Indonesia on overseas data alone. A verification result generated inside Indonesia must be added.
• HIV-related products must be tested at the Indonesian National Reference Laboratory (RSCM) according to industry practical estimates, subject to the current Kemenkes designation.
• The first registration and the renewal are different projects with different evidence demands. Planning them as one continuous task is the root cause of renewal-stage failures, because the additional local evidence required at renewal is invisible in a plan built only around the first submission.
• Because IVDs follow the device regime, licence holders, submissions and portals all match the device track; no separate diagnostics agency or parallel authorisation system exists for IVDs in Indonesia.

2. Legal basis

The regulatory basis for the IVD track rests on three instruments read together. The classification of IVDs follows the device classification rules in Article 55 of Permenkes No. 5/2026, applying the A/B/C/D risk classes to diagnostics as to other devices. The renewal-stage evidence obligations for TTI screening IVDs are found in Appendix 3 of Permenkes No. 11/2025, which specifies the sensitivity and specificity documentation and the verification test report from a Minister-designated laboratory or testing institution, and which identifies the acceptable testing bodies as accredited laboratories within Indonesia, certified testing institutions, or laboratories and testing institutions designated by Kemenkes. Finally, the identification of specific testing institutions, including the National Reference Laboratory RSCM for HIV-related products, rests on the current Kemenkes circulars and designations, so the operative designation must be confirmed against the instruments in force at the time of the project rather than against prior practice or secondary commentary. The practical reading of this structure is straightforward: Article 55 of Permenkes 5/2026 tells an IVD manufacturer which class the product carries, Appendix 3 of Permenkes 11/2025 tells the manufacturer what extra evidence the renewal of a TTI screening product demands, and the designation circulars tell the manufacturer where that evidence can lawfully be produced. Each question has one authoritative answer in one instrument, and a filing argument assembled from all three layers is complete in a way that no summary document can substitute for.

3. Expert insights

The renewal trap is the defining feature of the Indonesian IVD track. A first registration can proceed smoothly on the strength of overseas data, and then five years later the renewal stalls on local verification, because TTI screening reagents cannot be renewed on foreign data alone and a verification result generated inside Indonesia must be supplied. This is the most commonly encountered pitfall for Chinese IVD companies at the Indonesian renewal stage. The lead time is the hidden cost: designated laboratories have capacity limits, queues form, and a verification project started late cannot be compressed. Companies that treat local verification as a separate budget and schedule item, started as soon as the first certificate is issued rather than in the final months before renewal, avoid the queue entirely; companies that begin arranging testing only in the last stretch before renewal routinely face the risk of a licence gap caused by nothing more than a scheduling error. The remedy is structural rather than heroic: put the local verification into the project plan as a named workstream with its own budget, its own owner and its own deadline, anchored to the first certificate issue date instead of the renewal date, and the entire class of renewal failures disappears from the risk register for that product line.

4. Practical recommendations

• Plan local verification for IVD projects as an independent budget and timeline item, not as a subtask absorbed into the registration cycle.
• Start local verification scheduling immediately after the first certificate is issued, so the testing queue is entered early and the renewal date is never dependent on laboratory availability.
• At project initiation, confirm with the licence holder whether the product falls within the category requiring local testing, and confirm the testing cycle and cost with the relevant institution.
• For TTI screening reagents, assemble the sensitivity and specificity documentation to the statutory TTI screening standards well before the renewal window opens, so the documents and the local verification report are ready together.
• Verify the current designation of testing institutions, including RSCM for HIV-related products, against the current Kemenkes designations rather than relying on industry practical estimates alone.

5. Verification checklist

• □ Permenkes No. 11/2025, Appendix 3 (additional renewal requirements for TTI screening IVDs).
• □ Permenkes No. 5/2026, Article 55 (classification).
• □ Current Kemenkes circulars on the designation of testing institutions for IVDs.
• □ Local testing arrangements (including RSCM) derive from industry public sources and are marked as subject to the current Kemenkes designation.

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