Indonesia

In Indonesia, health product regulation is overseen by the Badan Pengawas Obat dan Makanan (BPOM), operating under the authority of Presidential Regulation No. 80 of 2017 and supported by a range of product-specific regulations. BPOM is responsible for the pre-market evaluation and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. Medical devices and in vitro diagnostics are additionally governed by Ministry of Health (Kementerian Kesehatan, or Kemenkes) Regulation No. 14 of 2021, which establishes a tiered risk-based classification system (Class A through D) and corresponding registration pathways. All health products must obtain a distribution permit (Izin Edar) before entering the Indonesian market, and BPOM conducts technical assessments that encompass safety, efficacy, and quality reviews prior to approval.

Applicants must appoint a local Indonesian legal entity as the registered license holder, meaning foreign manufacturers are required to partner with a locally incorporated distributor or subsidiary to submit registration dossiers. Indonesia generally accepts the ASEAN Common Technical Document (ACTD) format for pharmaceuticals and aligns with ASEAN Medical Device Directive (AMDD) frameworks for devices, though BPOM may request additional local data or Indonesian-language labeling. In recent years, BPOM has introduced reforms to accelerate market access, including an expedited pathway for priority and orphan products, an online e-registration portal (BPOM RI Online), and recognition of approvals from stringent regulatory authorities (SRAs) such as the US FDA, EMA, and TGA to support faster evaluation. Mandatory halal certification, coordinated through the Badan Penyelenggara Jaminan Produk Halal (BPJPH), has also become an increasingly important compliance consideration for applicable health products.

Public procurement of health products in Indonesia is centrally coordinated through the Ministry of Health (Kemenkes) and executed via the national e-procurement platform, LPSE (Layanan Pengadaan Secara Elektronik), administered by the National Public Procurement Agency (LKPP). The national health insurance program, Jaminan Kesehatan Nasional (JKN), managed by BPJS Kesehatan, is a dominant driver of public health product demand, and formulary inclusion through the National Formulary (Formularium Nasional, or Fornas) and the e-Catalogue (e-Katalog) system is essential for suppliers seeking sustained public sector volume. Products listed on the e-Katalog are available for direct purchase by government health facilities at negotiated prices, bypassing traditional tender processes, making listing a strategic priority. At the subnational level, provincial and district health offices manage their own procurement budgets, which can create variability in purchasing priorities and administrative requirements across Indonesia's 34 provinces.

The private sector represents a substantial and growing channel, served through private hospitals, clinic chains, pharmacy retailers, and independent distributors, with purchasing decisions made at the facility or group level rather than through centralized tenders. Donor-funded procurement also plays a meaningful role, particularly for communicable disease programs: the Global Fund supports HIV, tuberculosis, and malaria commodity procurement; Gavi co-finances vaccine introduction and supply; and USAID, through mechanisms such as GHSC-PSM, provides technical and supply chain assistance for select health commodities. Indonesia maintains an explicit local manufacturing preference policy under Government Regulation No. 29 of 2018 on industrial value, which awards scoring advantages in public tenders to products with local content (TKDN, or Tingkat Komponen Dalam Negeri) certification. This policy creates a significant incentive for foreign manufacturers to establish local production partnerships or technology transfer arrangements to remain competitive in the public procurement market.