Indonesia Medical Device Classification: Classes A, B, C and D

1. Key takeaways

Indonesia classifies medical devices into four risk classes, and the classification assigned to a product determines the depth of the dossier, the evaluation time limit and the official fee band. The classification is decided by the rules, not chosen by the applicant, so the analytical work should be treated as a regulatory deliverable in its own right rather than a formality.

• The four classes are A (low risk), B (low to medium risk), C (medium to high risk) and D (high risk), established under Article 55 paragraph 2 of Permenkes 5/2026.
• Indonesia has no Class II tier. The Indonesian scale cannot be mapped directly onto the European I, IIa, IIb, III scale or the United States I, II, III scale, and the class must be determined afresh under the Indonesian rules.
• The technical source of the classification rules is harmonisation with the ASEAN Medical Device Directive (AMDD), whose rule core is consistent with GHTF and IMDRF principles. Under Article 55 paragraph 4 of Permenkes 5/2026, the technical guidance on classification is to be issued separately by the Minister, so the detailed determination rules must be read in the technical documents subsequently published by Kemenkes.
• Classification is decided by the rules, not selected by the applicant (Article 55 of Permenkes 5/2026). The grounds of classification must be submitted with the filing and are reviewed during evaluation; a classification error affects the subsequent dossier depth, evaluation time limit and fee band.
• By third-party registration database statistics, as of 20 October 2026 Indonesia held approximately 86,800 registered records: approximately 26,868 in Class A, 39,267 in Class B, 17,885 in Class C and 2,846 in Class D. Class B is the largest volume band and Class D the scarcest. Separately, AKL records for imported devices stood at approximately 66,120 against approximately 20,747 AKD records for locally produced devices, reflecting a market structure highly dependent on imports.
• The class drives three consequences at once: the dossier depth, because Class C and Class D products require clinical evidence; the evaluation time limit, set at 21 working days for Class A, 36 for Classes B and C and 55 for Class D; and the official fee band, set at IDR 1,500,000 for Class A, IDR 3,000,000 for Classes B and C and IDR 5,000,000 for Class D. Misclassification therefore distorts cost and schedule estimates across the whole project.

2. Legal basis

The classification system is anchored in Article 55 of Permenkes 5/2026. Paragraph 2 of that article establishes the four risk classes A, B, C and D. Paragraph 4 provides that the technical guidance on classification is to be determined separately by the Minister, which means the operative determination detail lives in the Kemenkes technical documents issued under the regulation rather than in the article text itself. The rules are harmonised with the ASEAN Medical Device Directive, and the AMDD rule core is consistent with GHTF and IMDRF principles, which is useful context for companies already familiar with ASEAN filings elsewhere in the region, although familiarity does not remove the obligation to determine the class under the Indonesian instrument. A classification error carries three distinct consequences: the dossier depth changes, because Class C and Class D products require clinical evidence; the evaluation clock changes, set at 21 working days for Class A, 36 for Classes B and C, and 55 for Class D; and the official fee band changes, set at IDR 1,500,000 for Class A, IDR 3,000,000 for Classes B and C, and IDR 5,000,000 for Class D. Because all three consequences flow from the same single determination, the classification analysis is the highest-leverage regulatory decision in the entire Indonesian filing, and it deserves the same documentary rigour as the technical dossier itself: the rules applied, the evidence considered and the conclusion reached should all be traceable in the project record.

3. Expert insights

The consequences of misclassification range from correction requests and returned submissions to a finding that the filing was inaccurate. The deeper point is that classification is re-checked during evaluation, so an optimistic low-band filing does not stay unnoticed; when an evaluator raises the class, the dossier must be redone in full and the evaluation clock restarts, and the actual loss far exceeds the incremental cost of preparing to the higher band from the beginning. In other words, when the class is genuinely uncertain, the expected cost of the conservative path is lower than the expected cost of the optimistic path, once the probability of a review-driven upgrade is taken into account. Note also that the registration record statistics cited above come from a third-party regulatory database as of 20 October 2026 and are a third-tier source, suitable for scale reference only, not as an authoritative count; they should inform planning assumptions, not regulatory arguments.

4. Practical recommendations

• Determine the class against the current Kemenkes technical guidance on classification, and document the rule-by-rule reasoning for the class chosen, not just the conclusion.
• When the class is uncertain, prepare the evidence to the higher band rather than gambling on the lower band, because a review-driven upgrade forces complete dossier rework and restarts the evaluation clock.
• Do not map classes mechanically from EU or US classifications; re-derive the Indonesian class from the product characteristics under the Indonesian rules.
• Treat the classification rationale as part of the submission package, since the grounds must be submitted with the filing and are subject to review.
• Use third-party registration database statistics only as scale reference and label them as a third-tier source in any internal or client-facing analysis.

5. Verification checklist

• □ Permenkes No. 5/2026, Article 55 paragraph 2 and paragraph 4.
• □ ASEAN Medical Device Directive (AMDD) classification rules.
• □ Kemenkes technical guidance on device classification (as currently issued).
• □ Registration record statistics from a third-party regulatory database (as of 20 October 2026), a third-tier source for scale reference only.

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