1. Introduction Indonesia’s healthcare industry is growing rapidly, creating opportunities for both local and international medical device manufacturers and distributors. However, before entering the Indonesian
What is Medical Device Registration? Registering a medical device in Indonesia can feel complex, especially with the 2025 updates to Kemenkes regulations. This guide will
As technology advances, software is increasingly integrated into healthcare, whether embedded in physical devices or functioning independently as standalone medical applications. In Indonesia, medical device
The COVID-19 pandemic has made individuals more proactive about personal health. Home testing and monitoring devices (antigen/antibody self-test kits, digital thermometers, glucometers, pulse oximeters, etc.)
Indonesia imposes various import duties and taxes on cosmetics and medical devices. Understanding these rates is crucial for importers, distributors, and businesses looking to enter
You’ve invested millions in clinical trials across Europe or the U.S.—surely that should be enough to prove your medical device works, right? Not quite. In
Introduction The distribution permit (izin edar) for medical devices is a mandatory requirement before any medical product can be marketed in Indonesia. Its purpose is
The hCG Rapid Pregnancy Test falls under the category of in vitro diagnostic (IVD) medical devices, used to detect the hormone human chorionic gonadotropin (hCG)
Understanding whether your product qualifies as a medical device is a critical step in ensuring compliance with regulatory requirements. In Indonesia, medical devices encompass a
Why is Medical Device Distribution Important? The availability of medical devices is crucial for public health and the healthcare system. These devices not only support
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