Indonesia has introduced new rules to make halal certification easier for businesses through Government Regulation No. 42/2024 (GR 42/2024). This new regulation replaces the older
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
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
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
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
Substances prohibited from use in cosmetics as stipulated in the Regulation of the Food and Drug Supervisory Agency Number 17 of 2022, concerning Amendments to
Certificate of Free Sale, hereinafter abbreviated to CFS, means a certificate issued by the appropriate agency of a country that certifies that the Medical Devices,
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