The Indonesian Ministry of Health has issued Regulation of the Minister of Health of the Republic of Indonesia No. 5 Year 2026 regarding Health Supplies (Perbekalan Kesehatan).
This landmark framework serves as an umbrella regulation governing the comprehensive, end-to-end management of health supplies in Indonesia. Its scope encompasses pharmaceutical products, medical devices, household health products (PKRT), cosmetics, health supplements, traditional medicines, and food for special medical purposes (PKMK).
Read the full regulation here: [pdf]
The regulation is provided in Indonesian. English translation is not available.
Purpose of the Regulation
To establish a comprehensive regulatory framework governing the full lifecycle management of health supplies in Indonesia.
To support national health resilience, supply chain readiness, digital integration, and the prioritization of domestic products and local manufacturing.
Scope of Application
This Regulation applies to health supplies in Indonesia, including:
- Pharmaceutical products
- Medical devices
- Household health products (PKRT)
- Cosmetics
- Health supplements
- Traditional medicines
- Food for special medical purposes (PKMK)
Key Highlights
The Minister of Health Regulation No. 5 Year 2026 governs the entire lifecycle management of health supplies, covering:
- Strategic planning
- Production
- Procurement
- Distribution
- Circulation
- Market supervision
The regulation places a strong emphasis on:
- Strengthening national health resilience
- Ensuring supply chain readiness
- Driving digital integration
- Prioritizing domestic products and local manufacturing
Medical Device Requirements
With respect to the medical device sector, the regulation introduces and consolidates several critical compliance and operational aspects, including:
- Compliance with Good Manufacturing Practice (CPB) and Good Distribution Practice (CDB)
- Medical device classification based on risk classes
- Licensing and product registration requirements
- Import and export provisions
- Emergency Use Authorization (EUA) and Special Access Importation pathways
- Integration with the National Health Information System
Local Production and Technology Transfer
The regulation actively incentivizes local production and technology transfer initiatives, including contract manufacturing arrangements and the phased substitution of imported products with locally manufactured alternatives where feasible.
Implications to Clients
Clients should take note of the following implications:
- A heightened government preference toward domestically manufactured medical devices and products featuring higher Local Content Certification (TKDN)
- Potential impact on procurement activities and e-catalogue participation for imported products
- Increased regulatory expectations related to quality system compliance, supply chain traceability, and digital reporting obligations
- A strategic need to assess long-term localization or technology transfer strategies for imported products in Indonesia
- Sustained market access and opportunities for innovative or high-technology medical devices that cannot yet be produced by local manufacturers
- Availability of special importation pathways for research, exhibition, donation, emergency use, and healthcare service purposes
Effective Date
04 May 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Indonesia, please contact sales@andamanmed.com.