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
In accordance with Indonesian regulations, all products entering, circulating, and being traded within Indonesia must have halal certification. This requirement extends to various goods and
On November 24, 2019, the Indonesian government issued Government Regulation No. 80 of 2019 concerning Electronic System Trading (PPMSE). This regulation addresses crucial aspects of
General Requirements The requirements for medical device registration must be submitted using the following five forms: Distribution Permit Application Process Applicants submit medical device registration
What is ISO 13485 ISO 13485 is a quality management system (QMS) standard designed specifically for the medical device industry. Certification to this standard proves
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