on

Indonesia

IVDs regulated by Ministry of Health as medical devices
4 risk classes (A-D) aligned with ASEAN MDD
All IVDs require registration; some additional requirements for HIV and COVID tests
MoH total review timeline: 45-80 working days based on risk class

We handle the entire registration process, ensuring your medical devices comply with local regulations.

We handle the entire registration process, ensuring your medical devices comply with local regulations.

We handle the entire registration process, ensuring your medical devices comply with local regulations.

We handle the entire registration process, ensuring your medical devices comply with local regulations.