Class A Medical Device Registration in Indonesia: Pathway, Fees and Timelines

1. Key takeaways

Class A is the lowest-risk registration pathway for medical devices in Indonesia, and it is the route through which most simple, well-characterised products enter the market. Because the risk profile is the lowest of the four classes, the regulatory burden is lighter on the technical side, but it is not lighter on the administrative side. Two figures define the pathway: the official assessment clock for a new registration runs for a maximum of 21 working days, and where a product falls within the notification list (Notifikasi), the assessment clock shortens to a maximum of 12 working days, as set out in Annex 3 of Permenkes No. 11/2025.

• Class A is the lowest-risk pathway, with an official assessment clock of up to 21 working days for new registrations.
• Products on the notification list (Notifikasi) follow a shorter assessment clock of up to 12 working days.
• The official fee (PNBP) for a new Class A registration is approximately IDR 1,500,000; renewal or variation is approximately IDR 500,000, as reference values subject to the actual invoice issued by the Regalkes system.
• Administrative documents are not simplified: the LoA, CFS, ISO 13485 certificate and Indonesian-language labelling and instructions for use must still be submitted.
• End-to-end duration in industry practice is approximately 1-2 months, which is a practical estimate and not an official commitment.
• Halal obligations are the key new regulatory topic for Class A, with the start date postponed to October 18, 2028 under PP 40/2026.

2. Legal basis

The governing timeline provisions are found in Annex 3 of Permenkes No. 11/2025, which sets the maximum service durations in working days for each risk class. For Class A, a new registration is assessed within a maximum of 21 working days, while products covered by the notification list are assessed within a maximum of 12 working days. Classification itself is determined under Article 55 paragraph 2 of Permenkes No. 5/2026, which allocates devices to the four risk classes according to their intended use and inherent risk. The fee framework is the PNBP tariff applied through the Regalkes system: approximately IDR 1,500,000 for a new Class A registration and approximately IDR 500,000 for renewal or variation. These amounts are reference values, and the authoritative figure in any given case is the invoice actually generated by the Regalkes system at the time of payment.

It is essential to understand what the low-risk classification does and does not simplify. The technical depth of the dossier is reduced: the evidentiary expectations on clinical data and local testing, which are characteristic of higher classes, are not the same for Class A. What is not reduced is the administrative file. The Letter of Authorisation (LoA), the Certificate of Free Sale (CFS), the ISO 13485 quality management system certificate, and Indonesian-language labelling and instructions for use must all still be submitted. These documents serve a different purpose from technical evidence: they demonstrate that the parties are legally valid, that the source of the product is legitimate, and that a quality system exists. None of those demonstrations depends on the risk class, which is why they remain mandatory even for the simplest devices.

3. Expert insights

The most important forward-looking issue for Class A is halal certification. Class A devices are among the first device categories brought into the scope of mandatory halal certification. Although PP 40/2026 has postponed the starting date to October 18, 2028, the underlying work of ingredient traceability should begin well before that date. This is particularly true for products that contain animal-derived components, where the documentation chain behind each ingredient takes time to assemble and verify. Companies that treat the postponed date as a reason to wait will find the compliance workload concentrated in a short window, while companies that start mapping their materials early will absorb the obligation with far less disruption. A second insight concerns the perception of simplicity. Class A products are frequently treated by manufacturers as an entry-level, low-stakes category, a way of testing the Indonesian market. Yet precisely because the entry barrier is low and competition is dense, the authenticity of the registration certificate and the qualifications of the licence holder become the only real points of differentiation. A certificate that cannot withstand scrutiny, or a licence holder with incomplete credentials, undermines the entire market position regardless of how simple the product is.

4. Practical recommendations

• Plan the regulatory file in two parallel tracks: the technical dossier, which is lighter for Class A, and the administrative pack of LoA, CFS, ISO 13485 and Indonesian labelling, which carries the same weight as for any other class.
• Verify early whether the product falls within the notification list, because the difference between the 21-working-day and 12-working-day assessment clocks changes the project calendar.
• Treat PNBP figures as reference values only, and confirm the payable amount against the invoice actually issued by the Regalkes system before budgeting.
• Apply the full selection standard when choosing a licence holder, even though the product is Class A; the qualifications of the licence holder are the only differentiation that matters in a crowded, low-barrier category.
• Start halal ingredient traceability now, especially for products containing animal-derived components, instead of waiting for the postponed start date of October 18, 2028.
• Communicate the end-to-end duration of 1-2 months to internal stakeholders as a practical estimate, never as an official commitment, and keep the official 21-working-day clock separate from the project clock.

5. Verification checklist

• □ Permenkes No. 11/2025 Annex 3: 21 working days for Class A new registrations, 12 working days for the notification list.
• □ PNBP fee rates: IDR 1,500,000 for a new Class A registration, IDR 500,000 for renewal or variation, as reference values against the current Regalkes invoice.
• □ Permenkes No. 5/2026 Article 55 paragraph 2 for classification.
• □ End-to-end duration figures are industry experience values, marked as a practical estimate and not an official commitment.
• □ Data verified as of October 26, 2026, pending verification against the current Regalkes invoice at the time of any 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