In Vitro Diagnostics (IVD) Product Registration in Indonesia: Classification and Local Requirements
In Indonesia, the registration and approval of In Vitro Diagnostic (IVD) products are overseen by the Ministry of Health (MoH). All IVD devices must secure a registration number and a product license (marketing license) from the MoH before they can be legally imported and distributed. The registration process is considered relatively fast and cost-effective.
Classification and Review Timelines
IVD device classification in Indonesia is harmonized according to the ASEAN Medical Devices Directive (AMDD) and closely follows Global Harmonization Task Force (GHTF) guidelines. The classification determines the required documentation and the official timeline for approval:
| IVD Classification | Time Frame (Working Days) | Government Fee (Approx.) |
|---|
| Class A | 30 days | US$115 (IDR 1,500,000) |
| Class B | 60 days | US$230 (IDR 3,000,000) |
| Class C | 60 days | US$230 (IDR 3,000,000) |
| Class D | 90 days | US$340 (IDR 5,000,000) |
Note: For novel devices, the Director General may request a scientific review by an expert team, which will add time to the process but no additional fee.
Mandatory Local and Technical Requirements
For a foreign manufacturer to successfully register an IVD product, several requirements must be met:
- License Holder Requirement: The product license must be issued to a local, licensed distributor in Indonesia. This license is non-transferable and can only be held by one entity per product at a time. The local distributor acts as the sole authorized representative.
- Reference Country Approval: Reference country approval (such as from the EU, US, Japan, etc.) is required prior to submitting the IVD device registration application to the MoH.
- Technical Documentation:
- IVD Instruments: Require IEC 61010-1:2001 reports.
- Class II and Class III IVD Devices: Require performance/characteristic evaluation reports.
- Special Testing: Applications for high-risk IVD devices, specifically HIV reagents and kits, require performance test reports generated at the Indonesia Reference National Laboratory Hospital (RSCM).
Once issued, the IVD product license is valid for up to 5 years.
Anonymous
We are currently using a local distributor as our NIE holder, but we want to switch to another company as an Independent License Holder (ILH) in 2026 to ensure market flexibility. If our current distributor refuses to sign the Letter of Release (LoR), can we use the 'termination of contract' clause under the 2025 Omnibus-linked regulations to force a transfer of the AKL license within the Regalkes portal?