In 2021, the Minister of Health (“ Minister ”) introduced Regulation No. 14 of 2021 on Business Activity and Product Standards for the Organization of Risk-Based Business Licensing Within the Healthcare Sector, which was subsequently amended by Regulation of the Minister No. 8 of 2022 (collectively referred to as “ Regulation 14/2021 ”). As its title suggests, Regulation 14/2021 set out various standards for healthcare sector business activities and products, as identified by Indonesian Standard Industrial Classification (Klasifikasi Baku Lapangan Usaha Indonesia– “ KBLI ”) codes, and addressed the implementation of risk-based licensing via an integrated electronic system.

Nine Standards for Healthcare Products and Activities Updated: November 2025 Transition Deadline Set
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