Advertising Approval and Compliance Rules for Medical Devices in Indonesia

1. Key takeaways

Medical device advertising in Indonesia requires prior approval. Kemenkes issues the Certificate of Advertisement Approval through the e-suka system: the PNBP fee is IDR 250,000, the processing time is 3 working days, and one approval covers one product. The dedicated rules for device advertising are set out in Permenkes No. 76/2013 (advertising of devices and PKRT).

• The core principle: objective, complete, non-misleading. This follows the same line as the definition of labelling in Permenkes 11/2025 — information must be presented objectively, completely and without misleading effect, whether in images, colours, text or a combination, in physical or electronic form (including links). Advertising obeys the same standard: claims must not exceed the approved intended use and performance claims.
• Five red lines appear repeatedly. ① Indication claims beyond the registered scope; ② absolute wording or efficacy guarantees (curative, 100% effective, first, and similar); ③ launching material without approval; ④ mixing professional-user and public-facing materials (promotion of professional-use devices should keep audience and content distinct); ⑤ missing Indonesian language (materials aimed at the Indonesian market must use Indonesian, consistent with the label).
• e-Katalog and e-commerce channels carry additional requirements. Permenkes 5/2026 formally regulates electronic commerce and emerging channels: distribution through electronic trading systems (e-commerce platforms or a company’s own digital channels) must connect with the National Health Information System (SIKN); e-prescriptions and electronic medical records must be integrated. New formats such as pharmaceutical vending machines are brought into regulation for the first time.
• Registration and advertisement approval are two independent approvals. Holding a marketing authorisation does not mean the advertisement may run. Advertising must be approved separately, and it is limited to the registered product and its approved uses.

2. Legal basis

The approval mechanics are documented in the Kemenkes Certificate Services Manual advertising approval entry, which records the operational parameters: IDR 250,000 PNBP, 3 working days, one product per approval, issued through the e-suka system. The substantive advertising rules for devices come from Permenkes No. 76/2013, which governs advertising of devices and PKRT. The content standard draws on Permenkes No. 11/2025, whose labelling definition requires information to be presented objectively, completely and without misleading effect in images, colours, text or their combination, physically or electronically. The channel rules come from Permenkes No. 5/2026, which brings electronic trading systems within the regulatory perimeter and requires connection to SIKN, integration of e-prescriptions and electronic medical records, and covers new distribution formats such as pharmaceutical vending machines. Together these instruments establish that an advertisement is a regulated object in its own right, distinct from the product registration it promotes.

3. Expert insights

The independence of the two approvals is where exporters lose money. Companies budget and plan around the marketing authorisation and assume that a registered product can be promoted freely. In the Indonesian framework the advertisement is approved separately, through its own application and its own fee, and its permitted content is bounded by the registered product and its approved uses. A launch campaign prepared in parallel with registration therefore has a hidden critical path: if the advertisement approval is not started in step, the marketing authorisation arrives and the campaign still cannot legally run.

The red lines are mostly content-discipline failures, not creative failures. Indication claims beyond the registered scope, absolute wording, efficacy guarantees, and audience mixing all stem from marketing teams writing for impact without sight of the registration file. The wording standard is strict precisely because the labelling definition in Permenkes 11/2025 is strict: whatever an advertisement says must remain objective, complete and non-misleading and must not exceed the approved intended use and performance claims. The language requirement adds an operational layer — materials for the Indonesian market must be in Indonesian, consistent with the label, so a translation step belongs inside the material workflow, not at its end.

Permenkes 5/2026 turns digital channels into regulated territory. Distribution through e-commerce platforms or a company’s own digital channels now requires connection with SIKN, with e-prescriptions and electronic medical records integrated, and formats such as pharmaceutical vending machines are regulated for the first time. This means promotional activity online can no longer be treated as informal space: the same approval and content discipline that applies to printed material extends to the digital estate, and channel compliance becomes part of advertising compliance rather than a separate commercial question.

4. Practical recommendations

• Make advertisement approval a mandatory gate in the launch-material release process. No promotional item should be published — at exhibitions, online, or in trade channels — before its approval is in hand.
• Start the e-suka application in parallel with registration, not after it. With 3 working days of processing and one product per approval, timing the application is easy; discovering the dependency late is expensive.
• Audit every claim against the registered intended use and performance claims. Maintain a claims matrix linking each marketing statement to its registration source, so absolute wording and out-of-scope indications are caught before printing.
• Separate professional-user materials from public-facing materials. Keep audience and content distinct for professional-use devices, and keep every Indonesian-market item in Indonesian, consistent with the label.
• Extend the same control to digital channels. Treat e-commerce listings and own-channel content as regulated advertising, and track the SIKN connection requirements introduced by Permenkes 5/2026.

5. Verification checklist

• □ Kemenkes Certificate Services Manual confirmed: advertisement approval entry, IDR 250,000 / 3 working days / 1 product (verified 26 October 2026)
• □ Permenkes No. 76/2013 confirmed: advertising of devices and PKRT
• □ Permenkes No. 11/2025 confirmed: labelling definition — objective, complete, non-misleading
• □ Permenkes No. 5/2026 confirmed: e-commerce and new-channel rules, SIKN connection
• □ All current promotional materials checked against the five red lines
• □ Advertisement approval obtained via e-suka for every product being actively promoted

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