Class B Medical Device Registration in Indonesia: CSDT Dossier and Review Focus

1. Key takeaways

Class B sits at the moderate-risk level of the Indonesian classification system, and its regulatory profile is defined by three anchors: an official assessment clock of up to 36 working days for new registrations, the same duration that applies to Class C, and an official fee structure that is materially higher than Class A. The dossier must be organised according to the ASEAN CSDT (Common Submission Dossier Template), which has been the standard submission format in Indonesia since 2018, when the country began harmonising with the AMDD. What reviewers concentrate on is not volume but consistency: four categories of evidence and, above all, the alignment of product identification information across every document in the file. None of these anchors is difficult in isolation, but together they determine whether the application clears the assessment in a single pass or consumes its limited deficiency rounds on avoidable administrative corrections.

• Official assessment clock for a new Class B registration: up to 36 working days, the same as Class C.
• PNBP fee of approximately IDR 3,000,000 for a new registration; renewal or variation approximately IDR 1,000,000, as reference values.
• The dossier follows the ASEAN CSDT structure, aligned with the AMDD since 2018.
• Reviewers focus on four evidence categories: quality system, risk management, performance and verification data, and labelling.
• Clinical data is generally not mandatory for Class B, but may be requested for specific products.
• The most common deficiency is inconsistent product identification across the LoA, CFS, CSDT and label; only two deficiency rounds are available.

2. Legal basis

The 36-working-day assessment clock for Class B is set in Annex 3 of Permenkes No. 11/2025, which applies the same maximum service duration to Class B and Class C new registrations. The PNBP fee for a new Class B registration is approximately IDR 3,000,000, with renewal and variation at approximately IDR 1,000,000; these are reference values, and the authoritative amount is the invoice issued by the Regalkes system. The dossier format obligation derives from the ASEAN CSDT (Common Submission Dossier Template), adopted within the AMDD framework, with which Indonesia has been harmonising since 2018. The core CSDT sections relevant to a Class B submission include the executive summary, the checklist of Essential Principles of safety and performance, the device description and intended use, the summary of design verification and validation, the risk analysis conducted under ISO 14971, and the manufacturer information. The supporting standards referenced in the evidence expectations are ISO 13485 for the quality management system, ISO 14971 for risk management, and the applicable clauses of the IEC 60601 series for electrical safety. Because the CSDT is a template rather than a free-form narrative, each section carries defined expectations, and assessors navigate the dossier section by section; presenting the mandatory sections in the expected order and with the expected content is itself part of meeting the format obligation.

3. Expert insights

Assessors for Class B applications concentrate on four types of evidence. First, quality system evidence: the overseas manufacturer’s ISO 13485 certificate, with close attention to whether the certificate scope actually covers the product being registered; a certificate that lists a different product family is a recurring trap. Second, risk management documentation prepared under ISO 14971. Third, performance and verification data, including electrical safety testing to the IEC 60601 series, EMC results, sterilisation validation and biocompatibility assessment, as applicable to the device type. Fourth, labelling and instructions for use in Indonesian, complete in their information content. On the clinical question, Class B is generally not a class where clinical data is mandatory, but it is not a class where it can be ruled out either. For particular products, such as invasive devices, devices in long-term contact with the body, or devices incorporating new materials, assessors may request supplementary clinical evaluation or literature-based justification. The correct reading is that Class B is the tier where additional data may be requested, not the tier where it is definitively unnecessary. Applicants should therefore treat the clinical question for Class B as product-specific: a simple non-invasive device with well-established technology is unlikely to attract a clinical request, while an invasive or long-term-contact design may. The most frequent deficiency trigger is prosaic: inconsistent product identification. The product name and model on the LoA, the information on the CFS, the description inside the CSDT, and the model on the label must match exactly across all four locations. Indonesian assessment shows very low tolerance on this point, and even small discrepancies trigger a deficiency request, while only two deficiency rounds exist in total.

4. Practical recommendations

• Run a four-way alignment check before submission across the LoA, CFS, CSDT and label, confirming that product names, models and specifications are identical in every document.
• Use a field-by-field comparison table during the finalisation stage of the dossier; this single step eliminates most non-technical deficiencies.
• Check that the ISO 13485 certificate scope explicitly covers the product under registration before the file is submitted, not after a deficiency notice arrives.
• Assemble the IEC 60601 series, EMC, sterilisation validation and biocompatibility evidence according to what is applicable to the device, and map each report to the relevant CSDT section.
• Treat the two deficiency rounds as a scarce resource and budget responses for speed and completeness, since only two rounds exist for the whole assessment.
• Budget the PNBP at approximately IDR 3,000,000 for the new registration and approximately IDR 1,000,000 for renewal or variation as reference values, and confirm against the actual Regalkes invoice.

5. Verification checklist

• □ Permenkes No. 11/2025 Annex 3: 36 working days for Class B new registrations.
• □ PNBP fee rates: IDR 3,000,000 for a new Class B registration, as reference values.
• □ ASEAN CSDT template under the AMDD framework.
• □ ISO 13485, ISO 14971 and the applicable clauses of the IEC 60601 series.
• □ Data verified as of October 26, 2026, pending verification against current official sources at the time of submission.

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