Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need Medical electrical evidence in Indonesia?
Describe your device to check whether Medical electrical evidence may apply, why, what facts are missing, and which official source to review.
1 maintained routes3 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 Medical electrical evidence check is screening
Checks whether electrical safety is dossier evidence or a separate national product certificate. Evidence is normally handled inside the medical-device registration route.
Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.
- Requirement family
- Medical electrical safety
- Regulatory object
- finished device
- Maintained rule status
- included in medical registration
- Useful product facts
- Power source, voltage, intended environment, patient connection, device type, and IEC/CB evidence.
Published Ditjen Farmalkes assessment guide (Pedoman Penilaian Alat Kesehatan dan PKRT): function/performance test evidence or a QC Certificate of Analysis for the finished device; electrically powered devices need electrical-safety testing per the IEC 60601 series (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), with the testing laboratory's ISO/IEC 17025 certificate; product-specific evidence quoted by the guide includes condoms (uji daya letup dan kebocoran) and sanitary pads (uji fluoresensi dan uji daya serap). PMK 14/2021 (as amended by PMK 8/2022 and 17/2024) was repealed in part by Permenkes 11/2025 (set 3 October 2025), which now carries the OSS health-sector business/product standards under PP 28/2025. PMK 54/2015 (device testing and calibration) was revoked by PMK 5/2026. Read the published assessment guidance subject to the current framework and the consistency condition for earlier implementing provisions in Permenkes 5/2026 Article 124.
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.
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
Wireless / radio
Komdigi telecommunications-device certification
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Adapters / components
SNI compulsory certification
Applies when the product, feature, component, or use is in scope.
No supporting source association
Halal / materials
Medical-device halal Class A
A transition is identified; the applicable date and current status must be checked.
Source association awaiting review
Halal / materials
Medical-device halal Class B
A transition is identified; the applicable date and current status must be checked.
Source association awaiting review
Halal / materials
Medical-device halal Class C
A transition is identified; the applicable date and current status must be checked.
Source association awaiting review
Radiation
BAPETEN radiation authorization
Applies when the product, feature, component, or use is in scope.
No supporting source association
Import CoC / PVoC
Kemenkes medical-device imports and special access
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Reviewed source associations
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.
Direktorat Jenderal Farmasi dan Alat Kesehatan
Pedoman Penilaian Alat Kesehatan dan PKRT — IEC 60601 electrical-safety evidence and BAPETEN Surat Izin Pemanfaatan Tenaga Nuklir
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)
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
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 maintained source associations, with reviewed, candidate and unresolved states shown separately.
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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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