Regulatory Affairs Update: Indonesia

Indonesia: Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through Electronic Systems

Indonesia Ministry of Health (MoH) shared Guidelines for the Circulation of Medical Devices and Household Health Supplies through Electronic Systems which was signed on 05 April 2024.

The guideline is intended as a reference for business actors, medical device and Household Health Supplies associations, and other stakeholders in implementing the circulation of medical devices and Household Health Supplies through electronic systems, including the implementation of supervision.

Indonesia MoH explains the provisions for business actors who distribute medical devices and Household Health Supplies products, the requirements for products that can be distributed via electronic systems, and the criteria for the types of the products. Apart from that, this guideline also contains information related to the supervision of medical devices and Household Health Supplies distributed through electronic systems to ensure that products in circulation meet safety, quality, efficacy, and benefit standards, as well as protecting the public from information that is not objective, incomplete, and misleading.

Refer to the following guidance in Indonesian here.

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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