Local Testing Requirements in Indonesia: Designated Categories, Institutions and Planning

1. Key takeaways

Indonesia does have local testing requirements — but they trigger by product category, not across the board. Once a product falls within a designated list, testing must be performed by accredited laboratories in Indonesia, certified testing institutions, or laboratories and testing institutions designated by Kemenkes. For everything outside the lists, local testing is not a default requirement — though it is never safe to assume a product will stay outside a reviewer’s discretion.

The category list matters commercially because local testing consumes time and budget that sit outside the registration cycle proper. Teams that identify category membership at project start can run testing in parallel with dossier writing; teams that discover it in a deficiency notice lose a full correction window.

• HIV-related products: must be tested at the Indonesian national reference laboratory (RSCM).
• Sanitary napkins, adult diapers, condoms and syringes: fluorescence testing required; testing institutions include Sucofindo and BPOM.
• Products with animal-derived materials (such as catgut): a disease-free certificate from the country of origin is required.
• Products involving radiation (such as X-ray equipment): a radiation safety certificate from the national nuclear energy agency (BAPETEN) is required.
• Software: a software verification report from the manufacturer or an independent laboratory is required.
• TTI screening IVDs: the one category with explicit textual support — sensitivity and specificity compliance documents plus a verification testing report from a minister-designated institution, required at renewal.
• Costs and durations: no unified public tariff; treat as an independent time and budget item.

2. Legal basis

The clearest textual anchor is Permenkes No. 11/2025, Appendix 3: for IVDs used in transfusion-transmitted infection (TTI) screening, the renewal stage requires supplementary sensitivity and specificity compliance documentation together with a verification testing report from a laboratory or testing institution designated by the Minister (see article 6). This is the only item on the practical category list with explicit provision behind it. The other categories rest on Kemenkes designations and current circulars; the category list itself — including RSCM, Sucofindo and BAPETEN — comes from industry public sources and is third-tier sourcing, subject to the official designation for the time being in force. The references below were verified on 26 October 2026.

On costs and durations, there is no unified public tariff: fees vary by product and test item, and queues form at the designated institutions. The practical estimate is therefore not a number but a planning posture — treat local testing as an independent time and budget item, not as a line inside the registration schedule, and take the testing institution’s current quotation as the governing figure.

3. Expert insights

Insight 1: the designated-institution rule is strict, and it bites the paperwork too. For products on the lists, the testing must come from accredited Indonesian laboratories, certified testing institutions, or laboratories and testing institutions designated by Kemenkes. A technically sound report from a foreign laboratory does not cure the gap, because the requirement is about who performs the test, not only what the test shows. This is why category screening has to happen before submission planning is finalised: the answer changes the budget, the calendar and the vendor list at once.

Insight 2: the TTI rule shows how specific the obligations can get. Permenkes 11/2025 Appendix 3 names the exact deliverables for TTI screening IVDs at renewal: sensitivity and specificity compliance documentation and a verification testing report from a minister-designated laboratory or testing institution. It is the one item with explicit provision behind it — everything else on the practical list is designation-based. The lesson generalises: where the regulation is explicit, the requirement is non-negotiable in form as well as substance, and where it is designation-based, the current list is the operative law of practice.

Insight 3: never assume that not being named means not being tested. Even for products outside the current lists, reviewers retain the authority to require supplementary testing for specific products. The practical defence is a three-step determination: first, check Kemenkes’ current designated testing list and institution roster; second, ask the licence holder whether they have submission experience with similar products — precedent is the most valuable intelligence here; third, confirm with the reviewing side during pre-submission communication. The three steps together replace assumption with evidence, at the cost of a few conversations.

4. Practical recommendations

• Screen the product against the designated categories at project start, before the submission plan and budget are fixed.
• Start testing scheduling before submission for categories clearly on the list, running it in parallel with dossier writing.
• Do not wait for the deficiency notice. Reacting after a correction round wastes an entire correction window and months of time.
• Check the current Kemenkes designated list and institution roster rather than relying on older industry summaries.
• Ask the licence holder for precedent submissions — prior experience with the same category is the best predictor of what the reviewer will request.
• Use pre-submission communication to confirm testing expectations where the product sits near a category boundary.
• Budget local testing as a standalone item with its own timeline, quoted by the testing institution for the time being.

The scheduling point deserves the emphasis it gets in practice. Testing capacity at designated institutions is finite and queues are real, so a slot reserved at project start is a schedule asset, not merely an administrative act. The difference between a parallel testing track and a reactive one is typically the difference between a submission that holds its date and a project that quietly loses a quarter.

5. Verification checklist

• □ Product screened against the current designated testing categories and institution roster
• □ HIV-related products routed to RSCM where applicable
• □ Fluorescence testing arranged at Sucofindo, BPOM or other accepted institutions for applicable categories
• □ Disease-free certificate from the country of origin obtained for animal-derived products such as catgut
• □ BAPETEN radiation safety certificate obtained for radiation-emitting products such as X-ray equipment
• □ Software verification report prepared by the manufacturer or an independent laboratory
• □ TTI screening IVDs: sensitivity and specificity documents plus designated-institution verification report ready for renewal
• □ Testing scheduled before submission, budgeted as an independent item against the institution’s current quotation

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