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
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
Symbol Description ManufacturerThis Medical Device Symbols must be displayed alongside the name and address of the manufacturer, positioned next to the symbol Authorized representative in
The supervision of advertisements for medical devices and household health supplies (PKRT) circulating in the community must be conducted in accordance with the applicable marketing
Medical devices have risks ranging from low risk to high risk that can potentially cause serious injury, to permanent disability and even death. Therefore, medical
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
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