Indonesia To Streamline Approval Process for More Than Two Dozen Low-Risk Medical Devices

Even as it pushes to more tightly regulate its growing medical device market, Indonesia is making it easier to register some non-sterile risk medical devices that do not require special skills and are considered low-risk.

Among the 34 devices that will be eligible for the streamlined registration process announced in July by Indonesia’s Ministry of Health are canes, crutches, ice bags, elastic bandages, arm slings, medical adhesive tape, and several dozen other devices often used at home and without the assistance of medical professionals.

In lieu of registering such devices in full, companies who already hold distributor licenses in Indonesia will be eligible, under the new system, to obtain what the Ministry has dubbed Distribution Permit Notifications. The new registration protocols are still being developed but are likely to be fully operational and available through Indonesia’s online registration platform by the end of this year.