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.