PNBP Official Fees for Medical Device Registration in Indonesia

1. Key takeaways

The official name of the government fee for device registration in Indonesia is PNBP (Penerimaan Negara Bukan Pajak, non-tax state revenue). Applications for a marketing authorisation must pay PNBP through electronic payment, and fees already paid are not refundable, even if the application is refused or delayed. For budgeting purposes this is the essential point: the official fee is a sunk cost. The rates themselves are modest relative to total project cost, and the dominant expenses sit outside the official fee entirely, in licence holder service fees, agency and consulting fees, document legalisation, sworn translation, local testing, clinical evidence and label localisation. A budget that stops at the PNBP schedule will mislead management about what market entry actually costs, and the gap grows with risk class, because higher-class submissions carry more testing and documentation work without any proportional increase in the official fee.

• PNBP is paid electronically and is non-refundable regardless of outcome, so it should be treated as a sunk cost in every budget.
• New registration PNBP: Class A IDR 1,500,000; Class B and C IDR 3,000,000; Class D IDR 5,000,000 (reference values, subject to actual Regalkes invoicing).
• Renewal or variation PNBP: Class A IDR 500,000; Class B, C and D IDR 1,000,000 (reference values).
• IDAK distribution licence PNBP: approximately IDR 1,000,000.
• Combining renewal and variation in one submission is charged at the renewal tier and saves a separate queue round and a separate variation fee.
• PNBP rates are government-set and may change; the actual invoice amount in the Regalkes system at the time of submission is authoritative.

2. Legal basis

The non-refundable character and the levy of PNBP for registration have their origin in Permenkes No. 62/2017, Article 23, and in current practice this principle is carried forward under Permenkes 5/2026. The application types subject to PNBP follow the annex 3 of Permenkes No. 11/2025. The rate table below reflects the reference values in use; the binding figure is the amount actually invoiced in the Regalkes system at submission.

The legal character of these amounts matters for planning. Because the rates are government-set pricing, they may be adjusted, and no historical figure from an article or a previous project should be used as a budget line without checking the current invoice amount. The reference values above are therefore marked as reference values throughout, pending verification against the prevailing schedule. In practical terms, the correct moment to fix the budget line is the point of submission, when the Regalkes system generates the actual invoice; every earlier figure is provisional by nature.

3. Expert insights

How large is the official fee within the total budget? Typically small. The heavy costs lie outside PNBP entirely: licence holder service fees, where an independent holder charges annually and per product; registration agent and consulting fees; document notarisation and apostille; sworn translation; local testing; clinical evidence; and localisation of labels and instructions for use. Comparing only the official fees between markets seriously understates the true project cost, and decisions taken on that basis tend to be wrong in both direction and magnitude. The same logic applies when comparing licence holder models: the PNBP line is identical regardless of who holds the certificate, while the service fee line differs sharply between a distributor-held licence, an independent holder and a company structure of your own.

On combining renewal and variation: yes, savings are real. A combined submission is charged at the renewal tier, IDR 500,000 for Class A and IDR 1,000,000 for Class B, C and D, and it resolves both matters at once, saving one round of queuing and one separate variation fee. The practical question is timing: the combined route works when the variation would have been needed before the renewal in any case, and it should be planned against the certificate expiry calendar rather than discovered late. Where the variation is substantive, the review burden of the combined file can offset part of the administrative saving, so the combination should be assessed per certificate rather than applied as a blanket rule.

4. Practical recommendations

• Build the budget in five columns: official fees, service fees, certified translation, testing or clinical work, and localisation, so that PNBP is never mistaken for the total cost.
• Mark the PNBP line explicitly as government-set pricing subject to the actual invoice, and pull the current amount from the Regalkes system at submission rather than from historical sources.
• Plan renewal and variation submissions so they can be combined where the certificate calendar allows, capturing the renewal-tier fee and the saved queue round.
• Record every PNBP payment as non-refundable in the project financials, so that a refused or delayed application does not create a false recovery expectation.
• Use the five-column structure to run cost comparisons across markets later, keeping official fees separated from the service-driven costs that dominate the total.
• Where multiple registrations run in parallel, aggregate the PNBP lines by class and application type so that the government-fee exposure is visible separately from the service-fee exposure.
• For the IDAK line, carry the approximately IDR 1,000,000 reference value separately from premises, personnel and CDAKB certification costs.

5. Verification checklist

• □ Confirm Permenkes No. 62/2017, Article 23, on PNBP and the non-refundable principle, currently carried forward under Permenkes 5/2026.
• □ Confirm the current Kemenkes PNBP rate schedule against the actual Regalkes invoice amount at submission.
• □ Confirm the application types subject to PNBP against annex 3 of Permenkes No. 11/2025.
• □ Note that all rates shown are reference values and are marked as such, pending verification against the prevailing schedule.

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