Medical Device Import Clearance in Indonesia: SKI, INSW and HS Codes

1. Key takeaways

The precondition for importing medical devices into Indonesia is simple and unforgiving: the marketing authorisation must come first, and import follows. Permenkes 5/2026, Article 50 paragraph (1) and Article 58 paragraph (4), make clear that devices may only be imported after the marketing authorisation has been obtained, and products sold without a licence must be removed from the market. The best practice that follows is to have the certificate in hand before the goods reach the port, not after. Demurrage, storage charges and return risks for uncertified goods arriving at port usually far exceed the waiting cost of securing the certificate in advance, and this is the most common avoidable loss in the Indonesian market. Around this core rule sit the SKI certificate, the INSW single window, HS code classification and a set of importer qualifications that foreign companies must satisfy through an Indonesian entity or a qualified local importer.

• Import requires a marketing authorisation first; selling without one leads to delisting of the products.
• SKI (Surat Keterangan Impor) is the document telling customs that the shipment consists of devices already holding marketing authorisation; it is applied for per batch, processed in 3 working days through e-suka, with a PNBP of IDR 250,000 and validity for 1 import.
• SKI cannot substitute for product registration and cannot be reused for other batches.
• All import activities, including second-hand or refurbished devices and SAS imports, must run through systems connected to INSW under Permenkes 5/2026.
• Importers need an NIB with the appropriate API classification (API-U for general importers, API-P for producer importers), plus product-level marketing authorisation and company-level IDAK.
• Foreign companies cannot apply directly for an import licence; they must establish an Indonesian legal entity or appoint a qualified local importer.

2. Legal basis

Three provisions of Permenkes No. 5/2026 anchor the import framework. Article 50 paragraph (1) and Article 58 paragraph (4) establish that import is permitted only after the marketing authorisation is obtained. Article 40 introduces supply chain resilience obligations: production facilities, distributors and drug management facilities must calculate and maintain a buffer stock of 10 percent to 30 percent of planned demand, and anticipated shortages must be reported to the government 6 months in advance. The INSW requirement sits in the same regulation, which directs that all import activities be conducted through systems connected to the Indonesia National Single Window, including imports of second-hand or refurbished devices and imports under the special access scheme; the relevant certificates are uploaded to the INSW portal and customs verifies on that basis. The importer licensing framework rests on the NIB with API-U or API-P classification under the current trade regulations, and the SKI entry follows the Kemenkes certificate service manual.

3. Expert insights

HS codes carry three distinct roles in the Indonesian device context. First, they determine tariff and trade control classification. Second, they drive halal obligation determination: industry practice shows that halal requirements have begun to be assessed at the customs stage according to HS code, and some products may encounter clearance problems before the matter even reaches the registration stage. Third, HS codes serve statistics and traceability. An incorrect classification therefore triggers three categories of risk at once: tax exposure, compliance exposure and clearance delay, and the halal dimension in particular can surface earlier in the supply chain than teams expect. Because the same code feeds all three functions, a classification reviewed only for tariff purposes is not fully reviewed, and the halal and traceability consequences should be checked explicitly at the same time.

The buffer stock obligation under Article 40 is a new operating constraint for distribution businesses. Maintaining a buffer of 10 percent to 30 percent of planned demand changes warehouse planning and cash-flow planning simultaneously, and the 6-month advance reporting duty for anticipated shortages makes demand forecasting a compliance activity rather than a purely commercial one. Combined with the pre-arrival certificate rule, the overall picture is that the Indonesian import regime rewards preparation and penalises improvisation at every step.

4. Practical recommendations

• Set certificate in hand as a hard gate for shipment: no goods leave the origin port before the marketing authorisation and the relevant certificates are secured.
• Apply for SKI per batch through e-suka, budgeting IDR 250,000 and 3 working days per consignment, and never reuse a SKI across batches.
• Verify the HS code classification of every product line against tariff, trade control and halal dimensions before the first shipment, and correct any legacy misclassifications.
• Confirm the importer’s NIB and API classification (API-U or API-P) and its company-level IDAK before appointing it, since foreign companies cannot hold the import licence directly.
• For refurbished or second-hand devices, plan explicitly for the INSW-connected route rather than assuming standard clearance applies.
• Build the buffer stock requirement of 10 percent to 30 percent of planned demand into warehouse and inventory planning, and establish an internal process to report anticipated shortages to the government 6 months ahead.
• Track the INSW upload of import-related certificates as a shipment deliverable, so customs verification is never waiting on paperwork.
• Where the distribution model involves multiple importers, standardise the document set and HS classifications across them so that clearance behaviour does not vary by counterparty.

5. Verification checklist

• □ Confirm Permenkes No. 5/2026, Article 40 (buffer stock and advance warning), Article 50 paragraph (1), and Article 58 paragraph (4) (licence before import).
• □ Confirm the SKI entry in the Kemenkes certificate service manual: per-batch application, 3 working days, PNBP 250,000, valid for 1 import.
• □ Confirm the INSW portal mechanism and the requirement that import activities run through INSW-connected systems.
• □ Confirm the importer licensing framework, NIB with API-U or API-P, against the current trade regulations, pending verification.
• □ Note that the link between HS codes and halal determination at customs is an industry practice observation, pending verification.

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