Indonesia Medical Devices
Indonesia’s Ministry of Health (MoH), through a Circular Letter HK.02.02/E/1289/2023 on Medical Devices Post Market Testing, announced that as of September 22, 2023, medical devices would require in-country post-market testing. MoH recommends distributor license owners carry out independent post-market testing on circulated medical device products to ensure products continue to meet safety and quality requirements.
The self-conducted post-market testing should be carried out periodically, at least once every two years, conducted by an accredited test laboratory in Indonesia and reported to the MoH’s Directorate of Medical Devices Supervision through its website.
This post-market testing of medical devices is voluntary. Products that have submitted independent post-market testing test results will be rewarded and receive a priority benefit, such as inclusion in the top selection products section of the e-Katalog. Those who have passed the post-market evaluation process will also be listed and published on the Directorate of Medical Devices Supervision website.
Medical devices that are a priority for independent post-market testing are as follows:
• Ultrasound
• Continuous Ventilator
• Infusion Pump
• Syringe Pump
• Condom
• Disposable syringes
• IV cannula
• IV catheter
• Wing needle
• Fistula needle
• Infusion set with needle
• Sterile gauze
• HIV RDT test
• RDT Syphilis test
• RDT Hepatitis test
• Dengue RDT test
• Implanted devices (Risk Class C and D)
• Sterile devices
• Medical Device Software
Although it is not mandatory, industry players raised concerns regarding this new post-market testing requirement. For instance, requiring testing every two years in-country will incur more significant costs for license holders and/or manufacturers. Furthermore, many manufacturers believe that this testing should be performed by local authorities and not be a burden to the license holder.
For more information and/or to talk through how to connect with a local distributor in Indonesia, please contact Pepsi Maryarini (Pepsi.Maryarini@trade.gov)