INDONESIA · MEDICAL DEVICES

Indonesia Medical Device Regulation 2026: Key Changes Under MoH Regulation No. 5/2026

Indonesia medical device regulation 2026 brings a major new health-supplies framework through Permenkes No. 5 Tahun 2026, effective from 4 May 2026.

The regulation is broader than medical device registration alone. It covers the planning, production, supply, circulation, control and supervision of health supplies, including medical devices and household health supplies (PKRT).

For overseas manufacturers, the most important point is the integration of product registration, import, local distribution, public procurement and post-market reporting. Permenkes No. 5/2026 also replaces earlier regulations, including the previous medical device marketing-authorisation framework under Permenkes No. 62/2017.

Risk-based classification remains the foundation

Indonesia continues to classify medical devices according to risk: Class A for low risk, Class B for low-to-moderate risk, Class C for moderate-to-high risk, and Class D for high risk.

The basic risk-based approach remains familiar, but manufacturers should assess products under the current framework rather than relying only on older registration references. Intended use, principal function and mode of action remain central to classification.

Marketing authorisation remains central to import and supply

Imported medical devices and PKRT must hold the appropriate Indonesian marketing authorisation, or izin edar, before normal commercial import. Permenkes No. 5/2026 connects import procedures with electronic systems integrated with the Indonesia National Single Window.

Manufacturers should align the registered product, Indonesia medical device importer, HS code and local regulatory structure before shipment. Limited special-access or import-certificate mechanisms apply in specific circumstances; they should not be treated as substitutes for normal commercial registration.

Local distribution and licence-holder structure still matter

Distribution must be carried out through appropriately licensed facilities or distributors. Overseas manufacturers should therefore plan their local regulatory and distribution structure before filing.

The choice of local licence holder, importer and distribution arrangement can affect registration, future supply, distributor changes and post-market responsibilities. This is particularly important where manufacturers want to maintain regulatory control separately from commercial distribution.

Domestic-content policy is becoming more relevant to market access

Permenkes No. 5/2026 emphasises domestic production and locally produced components. Government and healthcare procurement must prioritise domestic components, using domestic-content value (TKDN) or domestic marketing authorisation in accordance with applicable rules.

The regulation reinforces electronic-catalogue procurement and provides for substituting imported products with domestic alternatives, taking account of production capacity and whether healthcare needs can be met. For manufacturers targeting public-sector sales, TKDN, local production strategy and e-Katalog planning should therefore sit alongside product registration.

Digital reporting extends beyond initial registration

The framework places importance on integrated health-information reporting. Production facilities, distributors and relevant healthcare facilities must report supply activities through health-information systems integrated with Indonesia’s national health information system.

Ongoing compliance consequently requires operational coordination after approval. Manufacturers should establish who maintains supply records and handles applicable reporting, and ensure their local regulatory-holder structure can support those responsibilities. Availability planning should also account for potential supply disruptions.

What Indonesia medical device regulation 2026 means for overseas manufacturers

Permenkes No. 5/2026 brings several parts of the product lifecycle into one broader framework. A practical market-entry plan should connect risk classification and registration with local regulatory-holder structure, import arrangements, distribution compliance, public procurement and ongoing reporting.

The exact pathway still depends on the device class, intended use and commercial model. For manufacturers entering Indonesia for the first time, these decisions are best made before the registration application is filed.

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