The distribution of medical devices in Indonesia, including blood glucose monitoring systems, is regulated under Law No. 36 of 2009 on Health and Minister of
The distribution of medical devices in Indonesia, including oximeters, is regulated under Law No. 36 of 2009 on Health and Minister of Health Regulation No.
The Ministry of Health has issued an announcement to ensure the smooth importation of medical devices into Indonesia, specifically addressing the importation process for dermal
Medical device distributors in Indonesia are required to comply with CDAKB guidelines to obtain or renew their distribution licenses (IDAK). Achieving this compliance often involves
What is CDAKB? In Indonesia, Good Distribution Practices for Medical Devices, known as Cara Distribusi Alat Kesehatan yang Baik (CDAKB), establish standards for the distribution
A Distribution Permit Number (NIE) is an official license issued by the relevant authorities to distribute products in the market. The NIE ensures that the
Changes to medical devices and in vitro diagnostic devices with existing distribution permits can be classified as either significant or insignificant. This classification depends on
In the healthcare industry, manufacturers, distributors, and importers must maintain product quality and safety standards. They hold significant responsibility for recalling and destroying medical devices
Medical devices can be grouped and then registered in one application for distribution permit regThe registration requirements for grouped medical devices must comply with Regulation
The era of globalization has led to ease in and out of the goods including medical devices and household-health products. Rapidly growing technology of medical
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