Medical Devices & MOH Licensing
Overview
The circulation of medical devices and household health supplies (PKRT) in Indonesia is strictly regulated through registration systems at the Ministry of Health. We assist companies in processing marketing permits for both local (AKD) and imported (AKL) products, as well as formulation classification assistance (KFA) to ensure your products meet the required medical safety standards. In addition to marketing permit registration, we also assist in product registration into the LKPP E-Katalog system to open opportunities for your company in government procurement, providing broader market access with guaranteed administrative compliance.
Service Packages
Explore our comprehensive service packages tailored to your specific requirements.
Imported Medical Devices (AKL)
Imported Medical Device registration at MOH, including technical document review and principal coordination.
Domestic Medical Devices (AKD)
Local medical device registration service until AKD permit issuance.
PKRT Product Registration
PKRT Product registration including cleaners, disinfectants, and other hygiene products.
LKPP E-Katalog
Product registration assistance for LKPP E-Katalog for government procurement needs.
KFA (Medical Device Classification & Formulation)
Assistance in KFA preparation for medical device products before marketing permit registration.
Other Product Registration
Registration consultation services for special products not included in general categories.
Our Methodology
A structured and transparent workflow designed to deliver results within your target timeline.
Classification
Determination of AKL/AKD/PKRT category.
Dossier Prep
Preparation of technical docs & product files.
MOH Process
Submission via e-ALKES/OSS system.
Permit Issued
Official marketing permit received.
Official PNBP Fees
Detailed list of official government fees (PNBP) based on the selected package.
| Service Package | PNBP Fee (Rp) |
|---|---|
Schedule a Consultation
Please complete the form below to schedule a strategic briefing with our expert team.