IDAK 2026: New Medical Device Distribution Permit Rules in Indonesia If your company distributes medical devices in Indonesia — or plans to — the rules
A Production Certificate is a primary requirement for manufacturing Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies (PKRT). According to the Indonesian
There are 16 categories of medical devices and in vitro diagnostic medical devices that are limited based on their function and application in the health
Medical devices that do not meet standards and/or requirements may be subject to sanctions in the form of an order to withdraw from circulation and
The branch of a health equipment distributor is a business unit of a Health Equipment Distributor that has obtained a Certificate of Good Distribution Practice
Graha Bintara 4th Floor (ICI INSIGHTOF), Jl. Wolter Monginsidi No.43, Kebayoran Baru, Jakarta Selatan, Indonesia 12180
