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

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.

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