Indonesia: MOH Announces Post-Market Testing for Medical Devices

The Indonesian Ministry of Health urges the relevant License Holders to monitor regularly and report on the compliance of standard business licensing implementation in conjunction with the framework implementation of Government Regulations, No. 5/2021, Implementation of Risk-Based Business Licensing, and ensuring marketed medical devices meet up the standard quality, safety, and efficacy. The circular letter has mentioned a few messages as follows:

• The License Holders must independently carry out post-market testing on the marketed medical devices to make sure all products meet the required standards for quality, safety, and efficacy.

• The post-market testing is carried out a minimum of once periodically by the accredited laboratories and submit the post-market testing result to the MOH.

• The reports from the post-market testing will be taken into account for product selection for the e-Katalog.

This article will be updated for possible new updates on selected medical devices to undergo the post-market testing or enforcement date announced by the ministry. As for now, there are no specific instructions directed to a certain group of medical devices.

Source: Kementerian Kesehatan Republik Indonesia (KemKes)