Sponsors and manufacturers intending to export medicines and medical devices to Indonesia should be aware of new and emerging halal certification requirements under Indonesia's Halal Product Assurance framework.
Indonesia has progressively implemented mandatory halal certification under Law No. 33 of 2014 on Halal Product Assurance, with responsibility for certification now held by the Halal Product Assurance Organising Agency (BPJPH). These requirements expand the range of goods subject to halal obligations and are being phased in across product sectors, including medical products.
What this means for medicines and medical devices
Indonesia has introduced specific regulatory requirements for halal medical products, building on Presidential Regulation No. 6 of 2023 and Regulation of the Minister of Health No. 3 of 2024 (Permenkes 3/2024). These measures formally integrate halal considerations into manufacturing methods for drugs, biological products, and medical devices, as well as inclusion of material origin information for medical devices.
Under these regulations:
- Certain medicines and medical devices, including those containing or using animal‑derived materials, may be required to obtain halal certification from BPJPH.
- Compliance obligations extend beyond documentation and may affect product design, materials, manufacturing processes, packaging, quality management systems and staff training.
- The Indonesian Government is authorised to conduct external audits and inspections through regulatory and halal certification bodies to verify compliance with halal manufacturing requirements.
Mandatory halal certification for medical products is being phased in, with requirements expected to apply progressively from 2026, depending on device type and risk classification.
What sponsors and manufacturers should do
Sponsors and manufacturers exporting to Indonesia should:
- Consider whether their medical products contain, use or are processed with animal‑derived materials or other ingredients relevant to halal status.
- Monitor Indonesian regulatory developments and implementation timelines closely.
- Engage early with Indonesian regulatory counterparts or local representatives where halal certification may be required.
- Ensure appropriate documentation is in place and implement a halal assurance and certification process, where required under Indonesian regulations.
The Australian Government continues to engage with Indonesia to support Australian exporters and provide updated information as requirements evolve.
Industry webinar
On Friday 22 May 2026 at 2:30pm AEST, the Department of Foreign Affairs and Trade (DFAT), with the support of the Department of Agriculture, Fisheries and Forestry (DAFF), Austrade and the Department of Industry, Science and Resources (DISR), will host a one-hour industry briefing on Indonesia's import requirements for halal and non-halal products.
If you wish to attend, you can register here:
