Kemenkes Certificate Fees: Surat Keterangan Services via e-suka in Indonesia
Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
Beyond registration PNBP, Kemenkes levies separate official fees for the various certificates (Surat Keterangan) it issues through the e-suka system, each charged per item. These certificates cover export, import, sampling, product information and promotional activities, and they are a routine part of operating a registered device portfolio in Indonesia rather than an occasional formality. Based on the official Service Manual for medical device and PKRT certificates, the main categories, timeframes, PNBP amounts and validity periods are set out below. All rates and validity periods are officially published values and remain subject to the schedule current at the time of application.
| Certificate type | Timeframe | PNBP | Validity |
| Certificate of free sale (CFS, for export) | 3 days | 500,000 | 2 years |
| Export certificate | 3 days | 500,000 | 2 years |
| Health certificate | 3 days | 500,000 | 2 years |
| Special access scheme (SAS) | 5 days | 750,000 | 1 import |
| Sample import certificate (for obtaining marketing authorisation) | 3 days | 250,000 | 1 import |
| Raw material import certificate | 3 days | 250,000 | 2 years |
| Spare parts import certificate | 3 days | 250,000 | Until the marketing authorisation expiry date |
| Import certificate (SKI, customs) | 3 days | 250,000 | 1 import |
| Product information certificate | 3 days | 250,000 | 2 years |
| Recommendation letter / other information | 3 days | 250,000 | 2 years |
| Import authorisation certificate | 3 days | 250,000 | 1 import |
| Advertising approval certificate | 3 days | 250,000 | 1 product |
- The certificates most frequently used by Chinese companies are SAS for emergency import of unregistered products, sample import for registration purposes, SKI for per-batch clearance of registered products, spare parts import for after-sales supply, and advertising approval for promotional materials.
- Most certificates are issued within 3 days; SAS takes 5 days.
- Paid amounts are per item, so recurring certificate needs translate directly into recurring per-shipment costs.
2. Legal basis
The fee schedule and processing times derive from the official Kemenkes Service Manual for Medical Device and PKRT Certificates (Pedoman Pelayanan Surat Keterangan Alat Kesehatan dan PKRT, published in a bilingual edition, available through regalkes.kemkes.go.id and sertifikasialkes.kemkes.go.id). Applications are lodged through the e-suka system at esuka.binfar.kemkes.go.id. Certificates connected to import and export activities, including SAS, raw material and spare parts certificates, are uploaded to the INSW portal, where customs verifies them. All amounts in the table are officially published values and are subject to the schedule applicable at the time, pending verification.
The application process runs in seven steps: first, the company registers and obtains an account on e-suka; second, it submits online and uploads the required documents; third, a reviewer checks completeness and correctness, and non-compliant submissions are returned or rejected; fourth, once the documents are complete, the payment bill (SPB) is generated; fifth, payment is made to the designated bank and the payment receipt is uploaded; sixth, after payment verification the certificate is issued; and seventh, import and export related certificates, such as SAS, raw material and spare parts certificates, are uploaded to the INSW portal.
3. Expert insights
The cost structure of these certificates is deceptively simple. Each certificate carries a modest PNBP, but the frequency of use determines the real burden. SKI in particular is applied for per batch, at IDR 250,000 each with a 3-working-day processing time. For products imported at high frequency, the SKI processing time and fee must be built into the per-shipment logistics cost and the customs lead time; otherwise the delivery cycle is systematically underestimated, and the error compounds across every shipment of the year. The same frequency logic applies to spare parts certificates for after-sales supply, where each import event triggers a fresh application. Validity periods add a second planning dimension: certificates valid for 2 years can be renewed on a predictable cycle, while single-import certificates must be re-applied for at every consignment, which makes their processing time a fixed component of the delivery schedule rather than an occasional inconvenience.
The SAS category deserves separate attention. At IDR 750,000 with a 5-day timeframe and validity for a single import, it serves emergency imports of products that are not yet registered. It is not a substitute for registration but a bridge for specific urgent situations, and reliance on it as a recurring channel is inconsistent with the licence-based import framework described elsewhere in this guide. For planning purposes, the honest use of SAS is a documented emergency with a defined path to registration, not a standing alternative to holding a marketing authorisation.
4. Practical recommendations
- Map your import calendar against the certificate categories before the first shipment, identifying which certificates are recurring (SKI, spare parts) and which are one-off (sample import for registration).
- Include SKI fees and the 3-working-day processing time in the per-shipment logistics cost and the clearance lead time for every high-frequency product.
- Register the company account on e-suka early, so that account setup does not delay the first certificate application.
- Prepare document packages to the completeness and correctness standard of the reviewer, since non-compliant submissions are returned or rejected and the timeline restarts.
- Track the SPB payment step and upload receipts promptly, because the certificate is only issued after payment verification.
- Where shipments depend on certificates uploaded to the INSW portal, confirm the upload has completed before goods arrive at the border.
- Use SAS only for genuine emergency imports of unregistered products, and treat it as a bridge rather than a distribution channel.
5. Verification checklist
- □ Confirm the fee schedule against the Kemenkes Service Manual for Medical Device and PKRT Certificates, bilingual edition, available via regalkes.kemkes.go.id and sertifikasialkes.kemkes.go.id.
- □ Confirm the e-suka system address at esuka.binfar.kemkes.go.id and the current account registration procedure.
- □ Confirm the INSW portal upload mechanism for import and export related certificates, including SAS, raw material and spare parts certificates.
- □ Note that all rates and validity periods are officially published values, pending verification against the schedule current at the time of application.
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
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us