{SPECIAL ARTICLE} Indonesia New Drug Registration Overview

All drug products which will be marketed in Indonesia shall be registered to National Agency of Drug and Food Control (NADFC – or locally known as BPOM). Before BPOM issued Marketing Authorization for drug products, BPOM will perform Pre-Market Control to assess the efficacy, safety and quality of…

{SPECIAL ARTICLE} Indonesian medical device regulation overview

In this report, below items related to registration of medical device in Indonesia are explained. Regulation to be applied for medical device in Indonesia. Classification of medical device and production certificates in Indonesia Common Submission Dossier Templates (CSTD) for each Medical Device Class The registration procedure, labelling and…