Class C Medical Device Registration in Indonesia: Clinical Evidence and PMS Requirements

1. Key takeaways

Class C covers medium-to-high risk devices in Indonesia, and it is the tier at which clinical evidence becomes a substantive requirement rather than a contingent possibility. The pathway shares its procedural frame with Class B: the official assessment clock for a new registration is a maximum of 36 working days, and the official fee structure is identical in amount. What distinguishes Class C is the evidentiary burden. Reviewers expect clinical evidence in some recognised form, local testing may be required depending on the product and the assessor’s judgement, and the renewal stage carries a hard obligation to submit a post-market surveillance report. Two workstreams therefore define a well-run Class C project: preparing the clinical evidence package and building the PMS data mechanism, both started in parallel during the registration stage itself.

• Official assessment clock for a new Class C registration: up to 36 working days, the same as Class B.
• PNBP fee of approximately IDR 3,000,000 for a new registration; renewal or variation approximately IDR 1,000,000, as reference values.
• Clinical evidence is required for Class C: clinical trial data, a clinical evaluation report, or equivalence comparison and literature review with sufficient justification.
• Existing CE or FDA approvals reduce the volume of supplementary data requested but cannot substitute for the clinical evidence itself.
• Local testing must be issued by domestically accredited laboratories, certified testing institutions, or laboratories designated by Kemenkes.
• Class C renewal requires a post-market surveillance (PMS) report, which makes PMS data accumulation a day-one obligation.

2. Legal basis

The procedural anchors for Class C are set in Annex 3 of Permenkes No. 11/2025, which fixes the maximum assessment duration for a new Class C registration at 36 working days and requires a PMS report at the renewal stage under the corresponding service standard. Classification is determined under Article 55 of Permenkes No. 5/2026, which allocates devices to the four risk classes. The PNBP fee for a new Class C registration is approximately IDR 3,000,000, with renewal and variation at approximately IDR 1,000,000; both figures are reference values, and the payable amount in any case is the one invoiced through the Regalkes system. The expectations for clinical evidence follow the ASEAN CSDT and the technical guidance issued by Kemenkes, which together define what forms of clinical documentation are acceptable and how they must be presented within the dossier.

On local testing, the requirement arises in two situations: when the assessor considers that performance verification under Indonesian population or environmental conditions is needed, or when the product falls within a specific category list. In either case, the testing must be issued by a domestically accredited laboratory, a certified testing institution, or a laboratory designated by Kemenkes; reports from laboratories outside these categories do not satisfy the requirement. Typical examples are found among certain IVD products, as discussed in the dedicated articles of this guide series.

3. Expert insights

The clinical question is the defining feature of Class C. The assessment expects clinical evidence, and that evidence can take three recognised forms: clinical trial data, a clinical evaluation report (CER), or, where sufficiently justified, an equivalence comparison against a predicate device combined with a literature review. Existing approvals from reference jurisdictions such as CE or FDA carry real weight: they can significantly reduce the volume of supplementary data the assessor requests. What they cannot do is replace the clinical evidence itself. An approval letter is not a substitute for the documented clinical rationale behind the product as submitted in Indonesia, and treating it as one is a recurring cause of deficiency requests. The renewal obligation is the second decisive point. Class C renewal requires a PMS report, which means the licence holder must accumulate post-market data continuously from the day the first certificate is issued, not scramble to assemble material in the fifth year. In practice, many companies pass the first registration smoothly and then stall at renewal, and the root cause is almost always the same: PMS was never recorded from day one, so there is nothing credible to report when the renewal window opens. Typical Class C product categories include ventilators, orthopaedic fixation devices, haemodialysis equipment, some implants, high-frequency electrosurgical devices, and blood glucose meters with their test strips; the definitive class of any product follows from the classification rules, and this list serves only as an indication of magnitude.

4. Practical recommendations

• Run clinical evidence preparation and PMS data mechanism establishment as two parallel workstreams, both started during the registration stage rather than after certification.
• Decide early which form of clinical evidence the submission will rely on, whether trial data, a CER, or equivalence and literature review, and assemble the justification before drafting the dossier.
• Leverage existing CE or FDA approvals to reduce supplementary data requests, but build the clinical evidence file on its own merits rather than on the foreign approval alone.
• Identify at the outset whether the product may require local testing, and if so, engage a domestically accredited laboratory, a certified testing institution, or a Kemenkes-designated laboratory.
• Set up the PMS data collection process on the day the first certificate is issued, so that the renewal-stage PMS report can be compiled from genuine continuous records.
• 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, confirming against the actual Regalkes invoice.

5. Verification checklist

• □ Permenkes No. 11/2025 Annex 3: 36 working days for Class C new registrations, and a PMS report required at renewal.
• □ Permenkes No. 5/2026 Article 55 for classification.
• □ PNBP fee rates: IDR 3,000,000 for a new Class C registration, as reference values.
• □ Clinical evidence requirements based on the ASEAN CSDT and Kemenkes technical guidance.
• □ 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