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Does my medical device need Kemenkes medical-device imports and special access in Indonesia?

Describe your device to check whether Kemenkes medical-device imports and special access may apply, why, what facts are missing, and which official source to review.

8 maintained routes7 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this Kemenkes medical-device imports and special access check is screening

Separates reusable product approval from consignment, customs, PVoC, CoC, and HS-code documents. Applies when the product, feature, component, or use is in scope.

Requirement family: Import conformity and shipment certificates
Regulatory object: commercial or special circumstance imports
Maintained rule status: mandatory if feature
Useful product facts: HS code for every shipped object, shipment purpose, importer, origin, product certificate, and consignment details.

Permenkes 5/2026 (effective 4 May 2026) Article 58(4) requires an izin edar for medical-device and PKRT imports; Article 58(5) allows the Minister to issue an import letter in specified circumstances, with procedures to be set by the Minister under Article 58(7). Article 60 provides for customs/post-border checks. Article 62 governs special access without an izin edar, including purpose-specific approval and exceptions for personal use and other enumerated needs; assess the exact purpose rather than treating every special-access shipment as requiring the same permission. Article 125 repeals, among others, PMK 14/2016 (complementary goods, market testing and after-sales import recommendations), PMK 51/2014 and 7/2020 (special access), and PMK 60/2017 (import supervision). Earlier implementing provisions survive only insofar as consistent with the new regulation (Article 124). The older published export/import guide is historical operational context and does not by itself establish current letter names, sample re-testing requirements or an exemption. Business/distributor licensing also requires the applicable OSS standards under Permenkes 11/2025.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Indonesia routes to check

Check every Indonesia route →

Electrical safety

Medical electrical evidence

Evidence is normally handled inside the medical-device registration route.

Wireless / radio

Komdigi telecommunications-device certification

Applies when the product, feature, component, or use is in scope.

Adapters / components

SNI compulsory certification

Applies when the product, feature, component, or use is in scope.

Halal / materials

Medical-device halal Class A

A transition is identified; the applicable date and current status must be checked.

Halal / materials

Medical-device halal Class B

A transition is identified; the applicable date and current status must be checked.

Halal / materials

Medical-device halal Class C

A transition is identified; the applicable date and current status must be checked.

Radiation

BAPETEN radiation authorization

Applies when the product, feature, component, or use is in scope.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

Kementerian Kesehatan (JDIH)

Permenkes 5/2026 — current medical-device import and special-access requirements (Articles 58, 60, 62), implementing-rule transition and repeals (Articles 124–126), effective 4 May 2026

Kementerian Kesehatan (JDIH)

Permenkes 11/2025 — current OSS health-sector business/product standards repealing PMK 14/2021 in part (set 3 October 2025, status Berlaku)

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Indonesia scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Indonesia?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.