MOH Indonesia Medical Device Registration
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Plan Indonesia medical device and IVD access with the correct local class, product route, eligible applicant, technical evidence and lifecycle controls.
How to register a medical device in Indonesia
Indonesia medical device registration: separate the product and local business permissions
The Indonesian Ministry of Health administers device and IVD market authorization. Imported devices generally use the applicable NIE/AKL product authorization, while domestic products have their own route. The local applicant/distributor must hold the appropriate Indonesian business and distribution permissions; an overseas manufacturer does not itself become an Indonesian distributor merely by applying for product registration.
Use the Regalkes portal and current instruments for the application category, technical requirements and electronic process. Assign a local authorized party with documented manufacturer authority, file access, complaint escalation and maintenance responsibilities.
Risk class, dossier and grouping
| Workstream | Requirement or decision |
|---|---|
| Classification | A, B, C or D under the Indonesian device/IVD rules |
| Grouping | Single, family, system or applicable IVD category with justified model scope |
| Local establishment | Eligible business/distribution activities, authorization and applicable CDAKB controls |
| Technical evidence | Route-specific CSDT, risk, performance, quality and reference evidence |
| Product information | Bahasa Indonesia content and labels consistent with the authorization |
Prepare intended use, manufacturer/sites, models, quality certificates, device description, test evidence, clinical/performance evidence where applicable, labels and required free-sale/reference documents. A prior FDA or CE dossier can support the evidence but is not automatically a complete Indonesian submission. See classification and regulatory requirements.
Software and AI: current technical requirements
KMK HK.01.07/MENKES/951/2026, effective September 7, 2026, adopts guidance for medical-device software and AI. Assess the product boundary, intended clinical role, software verification/validation, cybersecurity, version identification and the applicable clinical evidence. Certain imported software has specific local-validation conditions; do not turn that into a universal local clinical trial requirement for every device.
Use our current software/AI update alongside the official text if applicable. Changes in software, algorithms, intended use or population require a regulatory-impact assessment before treating them as routine commercial updates.
Halal implementation and labels
Halal obligations are separate from the Ministry’s medical-device authorization. Assess the current product/material/process scope under PP 42/2024 and BPJPH measures, including any non-halal disclosure treatment. They are not limited to a simple “contains animal material” test.
BPJPH’s 2026 implementation notice includes Class A medical devices in the phase moving into mandatory application from October 18, 2026 following the October 17 phase endpoint. Confirm the specific product and foreign-certificate arrangements. Do not invent a Class D/biological deadline or assume that every halal certificate expires after four years.
Control the approved mark or required disclosure, source-material evidence and Bahasa labeling/IFU. A halal statement does not replace product authorization, and a product licence does not settle halal compliance.
Maintenance and launch planning
Read the actual product-licence term and current renewal/change process. Plan renewal early; an internal nine-month preparation target is not automatically a universal statutory filing deadline. If representation changes, assess the formal holder/authorization procedure, dossier access and continued supply rather than assuming every case is an automatic transfer or mandatory cancellation.
Maintain postmarket monitoring, complaints, adverse-event reporting, field actions, distribution records and changes. Separate government fees, local services, translations, testing and certificates in the budget. A useful schedule distinguishes evidence generation, local readiness, authority processing and responses. Pure Global can coordinate those workstreams within a defined device-specific scope.
Regulatory Update · Oct 1, 2026Indonesia Software Medical Device GuidelineRegulatory Update · Feb 24, 2026Indonesia Halal Certification for Medical Devices under Perpres No. 6/2023Blog · Aug 24, 2026Medical Device Registration Verification 2026Blog · Nov 5, 2025Indonesia's Medical Device and IVD Import MarketVideo · Aug 11, 2025How to Register a Medical Device in IndonesiaRegulatory Update · Oct 20, 2026Singapore HSA Integration and HTA ScopeRegulatory Update · Oct 17, 2026TFDA Clinical Trial E-SubmissionsCase Study · Aug 5, 2026Vietnam IVD Registration for an Oncology AssayBlog · Oct 5, 2026China GMP inspection preparationBlog · Sep 6, 2026One Device, Three UDI Databases
Faster submissions. Predictable costs. Local support.
We provide turnkey regulatory support in Indonesia, all for a flat annual fee:
Dossier preparation and submission, powered by AI assisted workflows and regulatory experts.
In country representation, with Pure Global serving as your Local Authorized Representative.
Post market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post approval modifications, and renewals.
Frequently asked questions
The eligible Indonesian applicant/distributor needs the appropriate local permissions. Define the overseas manufacturer’s authorization and the local entity’s activities separately from the product NIE/AKL application.
No. Assess the applicable product, materials, process and non-halal disclosure framework under current rules. Halal compliance is separate from medical-device authorization and has class/product-specific implementation conditions.
BPJPH’s current notice includes Class A medical devices in the phase moving into mandatory application from October 18, 2026 after the October 17 endpoint. Confirm the specific product and applicable certification/disclosure arrangements.
No. Assess the change’s effect on intended use, algorithm, clinical performance, version, risk and applicable software/AI guidance. Determine the appropriate notification, change or new-authorization route before implementation.
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