Common Rejection Reasons for Medical Device Registrations in Indonesia

1. Key takeaways

A rejection in the Indonesian medical device registration process is issued when the assessment concludes that administrative and/or technical requirements are not met, or when the applicant fails to complete the file within the deficiency period. The rejection notice is issued in electronic form and can be viewed through INSW or the Regalkes system. A rejection is not a termination of the product’s regulatory prospects, but it does end the current application: resubmission requires starting the process again and paying the fees again. The practical defence against rejection is almost entirely preventive, because the six most frequent causes are all visible before submission and all curable in advance. None of them turns on obscure technical judgement; each is a matter of document discipline, validity management and careful classification argument, which means a well-organised applicant can remove nearly all of the rejection risk before the file ever reaches an assessor.

• Rejection follows from unmet administrative and/or technical requirements, or failure to complete within the deficiency period.
• The rejection notice is electronic and viewable through INSW or Regalkes; the application then ends and must be resubmitted with new fees.
• The six high-frequency causes are inconsistent product identification, invalid or missing entity qualifications, non-compliant CFS, non-compliant Indonesian labelling, mismatched quality system evidence, and classification disputes.
• The current framework allows a maximum of two deficiency rounds, 10 working days each for Classes A-C and 15 working days for Class D.
• The assessment clock pauses when a deficiency notice is issued and resumes once the file is completed.
• Fees already paid are not refundable, so a rejected application costs twice the official fee plus the time lost.

2. Legal basis

The two-round deficiency rule is set in Annex 3 of Permenkes No. 11/2025: a maximum of two deficiency rounds, with 10 working days per round for Classes A-C and 15 working days per round for Class D. The mechanics follow from the service standard: after a deficiency notice is issued, the assessment clock pauses, and it resumes once the requested materials are completed. The legal treatment of rejection, electronic certification and fee non-refundability derives from Articles 21 to 23 of Permenkes No. 62/2017, which are carried forward in current practice under Permenkes No. 5/2026. Article 23 paragraph 4 of Permenkes 62/2017 establishes the governing principle that non-tax state revenue already paid is not refundable, which is why resubmission after rejection means paying the PNBP again. Entity qualifications, namely the IDAK and CDAKB, are regulated under Permenkes No. 14/2021. It should be noted that the six high-frequency rejection causes summarised in this article are a practical consolidation of casework experience, not an enumeration written into any regulation.

3. Expert insights

The six causes deserve individual attention, because each has a distinct failure mode. First, 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 correspond across all four locations. Second, invalid or missing entity qualifications: an expired IDAK, a missing CDAKB, or an expired LoA. Third, a non-compliant CFS: expired, issued by an authority that is not recognised, or not covering the product under application. Fourth, Indonesian-language labelling and instructions for use that are non-compliant: missing altogether, of poor translation quality, or incomplete in key information. Fifth, quality system evidence that does not match: an ISO 13485 certificate whose scope does not cover the product, or one that has expired. Sixth, classification disputes, where the applicant’s classification differs from the assessor’s determination and no sufficient justification is provided. Each of these has one thing in common: it can be detected by a disciplined pre-submission review, which is why experienced teams spend their preparation budget on finding these faults themselves rather than leaving the discovery to the assessor. Two further insights sharpen the picture. A deficiency notice is not a failure signal; it is a normal part of the process, and the variables that decide the outcome are response speed and the one-pass fix rate. And on cost, the regulation sets no cooling-off period before resubmission, but because the PNBP already paid is not refunded, the actual cost of a rejection is double the official fee plus the time lost, a combination that dwarfs most service fee differences. Reading the six causes together also reveals a pattern: five of them are administrative in nature, and even the sixth, the classification dispute, is usually decided by the quality of the justification prepared in advance. Rejection in Indonesia is therefore less often a technical verdict than a documentation verdict.

4. Practical recommendations

• Run a four-way alignment check across the LoA, CFS, CSDT and label before submission, as described in the dedicated article of this series.
• Check the validity of all five qualification items, namely the IDAK, CDAKB, ISO 13485 certificate, CFS and LoA, and ensure they remain valid throughout the assessment period, with a margin of at least 6 months recommended.
• Have the Indonesian-language documents reviewed locally by the licence holder rather than delivering machine translation output directly.
• Track the deficiency clock once a notice arrives, and treat response speed and one-pass completeness as the governing metrics of the correction effort.
• Use the first-pass approval rate as the core selection criterion when choosing a registration service provider, rather than comparing quotations; the hidden cost of a single deficiency round, in time and re-queueing, usually far exceeds the difference in service fees.

5. Verification checklist

• □ Permenkes No. 11/2025 Annex 3: two-round deficiency rule.
• □ Permenkes No. 62/2017 Articles 21-23 on rejection, electronic certification and the fee non-refund principle, carried forward under Permenkes 5/2026.
• □ Permenkes No. 14/2021 for IDAK and CDAKB.
• □ The six rejection causes are a practical consolidation, pending verification against casework, not a statutory enumeration.
• □ Data verified as of October 26, 2026.

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