Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices

The Ministry of Health has outlined requirements for clinical trials conducted in Indonesia in Regulation No. 63, 2017 published on December 28, 2017.

Included are details on the required elements of a clinical trial application, and description of the application review process conducted by a Ministry of Health appointed Health Research Ethics Committee.  The local clinical trial standards, CUKAKB “Cara Uji Klinis Alat Kesehatan yang Baik”, are based on ISO 14155.

The new Rules are viewed as preparation for increasing the requirement for local clinical trial data for high risk Class C/D and novel medical devices registration applications in Indonesia.