Special Access Scheme and Import Permit Letters for Medical Devices in Indonesia

1. Key takeaways

The Special Access Scheme (SAS) is a channel provided by Kemenkes for devices that do not yet hold a marketing authorisation, operating on a per-batch basis for importation. Applications are made through the e-suka system, the assessment takes 5 working days, the PNBP fee is Rp750,000, and each approval is valid for a single importation. SAS is best understood by contrast with the SKI, which serves already-licensed products at the customs stage, and by the family of related letters available in the same system for samples, raw materials and spare parts. None of these instruments substitutes for product registration, and the reforms under Permenkes No. 5/2026 have tightened the channel further by requiring import activities to run through systems connected to the Indonesian National Single Window (INSW). For companies supplying the Indonesian market, the practical question is rarely whether these letters exist, but which one fits the situation at hand and how each one interacts with the registration timeline that sits behind it.

• SAS is the Kemenkes channel for devices without a marketing authorisation, granted per batch, applied through e-suka.
• SAS parameters: 5 working days assessment, PNBP Rp750,000, validity limited to one importation.
• SKI (Surat Keterangan Impor) serves licensed products per import batch: Rp250,000, 3 working days, one importation.
• Both SAS and SKI are per-batch, non-reusable for other batches, and never a substitute for registration.
• Related e-suka letters cover sample imports (Rp250,000, 3 working days), raw material imports (Rp250,000, valid 2 years) and spare part imports (Rp250,000, validity following the marketing authorisation expiry date).
• Under Permenkes No. 5/2026, all import activities, including SAS and second-hand or refurbished devices, must be processed through systems connected to INSW.

2. Legal basis

The SAS, SKI and the related import letters are defined in the Kemenkes manual on certificate letter services for medical devices and PKRT (Pedoman Pelayanan Surat Keterangan), which sets out the entry conditions, assessment durations and PNBP rates for each instrument. The parameters are explicit: SAS for unlicensed devices at Rp750,000 with a 5-working-day assessment and validity of one importation; SKI for licensed products at Rp250,000 with a 3-working-day assessment and validity of one importation; the sample import certificate letter for samples imported in order to obtain a marketing authorisation at Rp250,000 and 3 working days; the raw material import letter at Rp250,000 with a validity of 2 years; and the spare parts import letter at Rp250,000, whose validity follows the expiry date of the corresponding marketing authorisation, with one application corresponding to one marketing authorisation. The INSW integration requirement derives from Permenkes No. 5/2026, which requires all import activities, including SAS and second-hand or refurbished devices, to be processed through systems connected to the Indonesian National Single Window. The procedural framework also intersects with Permenkes No. 11/2025. All applications run through the e-suka system at esuka.binfar.kemkes.go.id.

3. Expert insights

The distinction between SAS and SKI is the first thing to fix in any import plan. SKI is the customs clearance document for a product that already holds a marketing authorisation, applied for at every import batch at Rp250,000 within 3 working days and valid for one importation. SAS is the exception channel for a product that has no marketing authorisation, at Rp750,000 within 5 working days and likewise valid for one importation. What the two share defines their limits: both are applied for per batch, neither can be reused for any other batch, and neither can replace product registration. Typical SAS scenarios include urgent clinical needs, compassionate use, exhibition samples, and products that have not completed registration but have a clear use requirement. In each of these cases the approval covers exactly one importation, so the operational cost of relying on SAS scales directly with the number of batches, which is precisely why it works for isolated needs and fails as a supply model.

The correct reading of SAS is that it is a limited exception before registration, not a bypass of registration. The practical consequence of the Permenkes 5/2026 reform is that the data linkage between the SAS application and the customs stage is now tighter, and the space for the pattern of goods arriving first and the certificate being sorted out afterwards has been further compressed. That makes the channel safer to use but far less forgiving of improvised planning. The sample, raw material and spare parts letters, meanwhile, are the everyday tools of the after-sales and local assembly scenarios, and companies that service installed bases in Indonesia rely on them routinely rather than exceptionally.

4. Practical recommendations

• Match the instrument to the situation: SKI for licensed products at customs, SAS only for unlicensed products with a genuine, limited use requirement.
• Remember that each SAS approval covers one importation only; a new approval is needed for every subsequent batch.
• Use the related e-suka letters deliberately: the sample import certificate letter for registration samples, the raw material import letter within its 2-year validity, and the spare parts import letter tied to the matching marketing authorisation.
• File all applications through the e-suka system and expect tighter data linkage with customs under the INSW integration required by Permenkes 5/2026.
• Do not plan commercial supply on SAS. If a product needs repeated SAS use, the registration planning is at fault, and proper registration should be started immediately rather than continuing to rely on the exception channel.
• Treat SAS as a rescue instrument for emergencies, never as a substitute market-entry strategy.

5. Verification checklist

• □ Kemenkes manual on certificate letter services (Pedoman Pelayanan Surat Keterangan): SAS, SKI and sample, raw material and spare parts import entries with their rates.
• □ Permenkes No. 5/2026 on the INSW integration requirement for all import activities.
• □ Permenkes No. 11/2025.
• □ e-suka system: esuka.binfar.kemkes.go.id.
• □ Data verified as of October 26, 2026, pending verification against current official publications.

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