The distribution of medical devices in Indonesia is a highly regulated and closely monitored activity by the government to ensure that every medical device circulating… Read More »The Medical Device Distribution Process in Indonesia
Selecting the correct legal structure is not merely an administrative formality when entering the Indonesian market; it is a foundational strategic decision that affects investment… Read More »Understanding the Difference Between PT PMA and PT PMDN
In the Republic of Indonesia, the circulation and commercialization of products that may affect public health such as processed food, cosmetics, traditional medicines, health supplements,… Read More »BPOM Nomor Izin Edar (NIE) for Product Registration
As Indonesia continues implementing mandatory halal certification under Law No. 33 of 2014 on Halal Product Assurance, businesses in the food, beverage, pharmaceutical, cosmetics, and… Read More »Halal Certification Procedure and Timeline in Indonesia
Introduction In the evolving digital economy, the Indonesian government enforces strict regulations on Electronic System Organizers (Penyelenggara Sistem Elektronik, “PSE”) through the Ministry of Communication… Read More »Electronic System Organizers (PSE) in Indonesia
In alignment with Indonesia’s commitment to enhance investment certainty and regulatory transparency, the Persetujuan Kesesuaian Kegiatan Pemanfaatan Ruang (PKKPR) officially referred to in English as… Read More »PKKPR for Business Licensing and Land Use Compliance
What is PBG? Definition and Legal Framework The Persetujuan Bangunan Gedung (PBG), or Building Approval, is a legally mandated regulatory instrument issued by the Indonesian… Read More »the Building Approval (PBG) in Indonesia
Introduction Hazard Analysis and Critical Control Points (HACCP) is a globally recognized food safety management system designed to prevent contamination risks in food production. HACCP… Read More »HACCP Certification: Ensuring Food Safety and Compliance
What is GMP? Good Manufacturing Practices (GMP) refer to a set of regulations and guidelines designed to Good Manufacturing Practices (GMP) are a set of… Read More »Understanding Good Manufacturing Practices (GMP) Indonesia
Introduction Pharmaceutical Wholesale Trade (Perdagangan Besar Farmasi or PBF) plays a crucial role in the distribution of pharmaceutical products in Indonesia. As a highly regulated… Read More »Pharmaceutical Wholesale Trade (PBF) in Indonesia
