How to Verify Indonesian Medical Device Licences via Regalkes

1. Key takeaways

Licence verification in Indonesia is free, fast and official: Kemenkes provides a public search function through the Regalkes portal, commonly referred to in the industry as the Info Alkes search. Any manufacturer, buyer or tender committee can and should use it, because a certificate that cannot be found and matched in the official record is not a certificate worth relying on.

• Kemenkes provides a public search function for device and PKRT registration information through the Regalkes portal. It is the official public source for verifying registered devices, PKRT products, industry data and distributor information.
• The search takes three steps. First, retrieve by certificate number (AKL or AKD prefix) or by product name. Second, check that three fields match: the licence holder name, the manufacturer name, and the product model or name. Third, check the validity status and the product risk class.
• If any one of the three fields does not match, be alert to certificate borrowing or a mismatched certificate, where the paper document and the official record tell different stories.
• The two moments when verification matters most are before selecting a licence holder, and before accepting delivery or entering a bid. Before selecting a licence holder, search how many AKLs the target company actually holds, whether their status is Active, and which risk classes they cover; that is more reliable than any introduction. Before accepting delivery or bidding, verify that the certificates the supplier provides are genuine and valid.
• The same public records support competitive landscape analysis: search by manufacturer to see which licence holders hold that manufacturer’s products in Indonesia and which categories they cover; search by licence holder to see whose products that company distributes.
• Some deeper searches require a third-party regulatory database (approximately 86,800 records as of 20 October 2026), which is a third-tier source.
• Verification costs nothing but attention: the search is public, the fields to check are fixed, and the check can be completed in minutes by a non-specialist, so the barrier to running it is organisational rather than technical.
• A certificate whose paper copy looks impeccable but whose official record is missing, expired or mismatched should be treated as absent, not as provisionally acceptable pending later clarification.

2. Legal basis

The verification function rests on the public search capability that Kemenkes operates through the Regalkes portal (regalkes.kemkes.go.id), together with Kemenkes statements on public registration information. The official record shows, for each registration, the licence holder, the manufacturer, the product designation, the validity status and the risk class, which is exactly the set of fields that the three-step check reads. Supplementary searches beyond the public portal, such as deeper competitive landscape analysis by manufacturer or by licence holder, may be performed with a third-party regulatory database; as of 20 October 2026 such databases held approximately 86,800 records, and they are a third-tier source to be used for orientation and scale reference rather than as an authority. The evidentiary logic is worth stating plainly: the official public record is the primary source for any certificate claim, and every other document, however polished, is secondary to what the official search returns.

3. Expert insights

Write certificate verification into the supplier qualification process as a precondition for payment. An expired certificate or a mismatched product name becomes a substantive risk at exactly the moments when money and obligations are already committed: at a hospital bid, where a disqualified certificate can invalidate the tender response, and at customs inspection, where documentation that does not match the official record stops the goods. The three-field match is deliberately simple enough to be run by a non-specialist in minutes, which means there is no operational excuse for skipping it; the cost of running the check is negligible, and the cost of skipping it is concentrated in the least recoverable moments of the commercial cycle. Where the public search cannot answer a question, such as the full portfolio of a large distributor, a third-party database can extend the picture, but the output should be labelled as a third-tier source and the decisive facts should still be confirmed in the official record. For portfolio analysis in particular, the combination works well in one direction: the official search confirms individual certificates beyond doubt, while the third-party database supplies the breadth that individual lookups cannot, and each source covers the weakness of the other when the findings are kept clearly separated by provenance.

4. Practical recommendations

• Run the three-step check on the Regalkes public search for every certificate relied upon: retrieve by AKL/AKD number or product name, match the licence holder name, the manufacturer name and the product model or name, then confirm the validity status and the risk class.
• Before selecting a licence holder, search the target company’s actual AKL holdings, their Active status and their risk class coverage, and treat that record as more reliable than any introduction or marketing material.
• Before accepting delivery or submitting a bid, verify that the supplier’s certificates are genuine and valid in the official record, and keep a dated screenshot or extract of the search result in the transaction file.
• Make certificate verification a precondition for payment in the supplier qualification process, so that no funds move before the official record confirms the certificate.
• Use the public records for competitive landscape analysis, searching by manufacturer and by licence holder, and use third-party databases for deeper searches only as a third-tier source for orientation and scale reference.
• Investigate immediately any mismatch among the three fields, since certificate borrowing or a mismatched certificate discovered before contracting is a cheap problem, while the same discovery at bid or customs stage is a costly one.

5. Verification checklist

• □ Regalkes public search function (regalkes.kemkes.go.id).
• □ Kemenkes statements on public registration information.
• □ Third-party regulatory database (approximately 86,800 records as of 20 October 2026) as a supplementary search means, a third-tier source.

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