BPOM Medical Device Regulations — Indonesian Regulatory Framework
In Indonesia, medical devices are regulated by the National Agency of Drug and Food Control (BPOM — Badan Pengawas Obat dan Makanan). All medical devices must obtain a Distribution Permit (Izin Edar / IE) before they may be lawfully sold or distributed in Indonesia. The regulatory framework is implemented under Ministry of Health (Permenkes) regulations and aligns with the ASEAN AMDD classification scheme (Class A, B, C, D).
Key requirements:
- Indonesian Local Representative (AKMD): Foreign manufacturers must appoint an Indonesian company or individual registered with BPOM as the local representative responsible for the IE application.
- Distribution Permit (Izin Edar): Required for Class B, C, and D devices; Class A devices may follow a streamlined notification process.
- Quality system evidence: ISO 13485 certificate or equivalent GMP evidence is typically required for Class B–D.
- Post-market surveillance: Mandatory adverse event reporting, field safety corrective action coordination, and periodic post-market studies.
📅 Effective / published: Ongoing regulatory framework; updates issued via Permenkes regulations
Foreign manufacturers must not sell directly to Indonesian buyers without a registered AKMD. The AKMD holds the IE and is jointly responsible with the manufacturer for product safety and regulatory compliance. Ensure all labelling includes Indonesian-language content as required.
View official source (BPOM) ↗