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Indonesia: Ministry of Health issued Circular Letter for Medical Devices Post Market Testing

On July 21, 2023, the Ministry of Health (MoH) issued Circular Letter HK.02.02/E/1289/2023 pertaining to Medical Devices Post Market Testing. In the framework of implementing Government Regulation of the Republic of Indonesia Number 5 Year 2021 (Implementation of Risk-Based Business Licensing), and to ensure that medical device products in circulation meets the requirements of safety, quality, and efficacy, it is necessary to implement routine supervision through License Holder reporting related to compliance with standards business implementation.

In this regard, MoH conveys several things as follows:

  1. License holders are expected to conduct post-market testing of products in circulation independently to ensure products keep continue to meet safety, quality, and efficacy requirements.
  2. Post-market testing is carried out periodically at least 1 time in 2 years in accredited test laboratories and reporting the post-market test results to the Directorate of Medical Device Supervision of MoH electronically.
  3. The post-market test result reports of the product will be a consideration for the selection of products in the e-Catalogue.

Based on the initial information received, this post-market test will be applied to all medical devices that have obtained approval licenses from the MoH and distributed in Indonesia territory.

Since the socialization has not been carried out by the Indonesia MoH, there is no clear information yet regarding who will be the accredited laboratory to carry out the test, how many products that must do the post-market test, and what is the type of testing required by the MoH. It would be expected that further details will be announced by the MOH in the future to give clear guidance to the stakeholders related to this announcement.

For further information on this draft, please refer to this link: reference document here

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